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CompletedNCT02111850Updated Mar 29, 2022Results posted

T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-DP0401 Positive

A Phase 1/2 interventional study of Anti-MAGE-A3-DP4 T Cell Receptor (TCR) Peripheral Blood Lymphocytes (PBL) and Cyclophosphamide in Cervical Cancer, Renal Cancer and Urothelial Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-03-29.

Sponsored by National Cancer Institute (NCI) · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
21
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Background:

The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with metastatic cancer that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patient s white blood cells with a retrovirus that has the gene for anti-Melanoma antigen family A, 3 (MAGE-A3)-DP0401/0402 incorporated in the retrovirus.

Objective:

The purpose of this study is to determine a safe number of these cells to infuse and to see if these particular tumor-fighting cells (anti-MAGE-A3-DP0401/0402 cells) cause tumors to shrink and to be certain the treatment is safe.

Eligibility:

  • Adult's age 18-70 with metastatic cancer expressing the MAGE-A3 molecule.

Design:

  • Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed
  • Leukapheresis: If the patients meet all of the requirements for the study, they will undergo leukapheresis to obtain white blood cells to make the anti-MAGE-A3-DP0401/0402 cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.}
  • Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the anti-MAGE-A3-DP0401/0402 cells and aldesleukin. They will stay in the hospital for approximately 4 weeks for the treatment.
  • Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking.
Read the detailed description

Background:

  • We have constructed a single retroviral vector that contains both and $ \<= chains of a T cell receptor (TCR) that recognizes the DP0401/0402 restricted Melanoma antigen family A, 3 (MAGE-A3) tumor antigen, which can be used to mediate genetic transfer of this TCR with high efficiency.
  • In co-cultures with HLA-DP0401/0402 and MAGE-A3 double positive tumors, the anti- MAGE-A3- DP0401/0402 restricted (anti-MAGE-A3-DP4) TCR transduced T cells secreted significant amounts of Interferon gamma (IFN-y) with high specificity.

Objectives:

Primary objectives:

  • Determine a safe dose of the administration of autologous cluster of differentiation 4 (CD4) cells transduced with an anti-MAGE-A3-DP0401/0402 restricted (MAGE-A3-DP4) TCR and aldesleukin to patients following a nonmyeloablative but lymphoid depleting preparative regimen.
  • Determine if this approach will result in objective tumor regression in patients with metastatic cancer expressing MAGE-A3-DP4.
  • Determine the toxicity profile of this treatment regimen.

Eligibility:

Patients who are human leukocyte antigens (HLA)-DP0401/0402 positive and 18 years of age or older must have

  • Metastatic cancer whose tumors express the MAGE-A3-DP4 antigen.
  • Previously received and have been a non-responder to or recurred following at least one first line treatment for metastatic disease.

Patients may not have:

  • Contraindications for high dose aldesleukin administration.

Design:

  • PBMC obtained by leukapheresis will be enriched for CD4 cells and transduced with the retroviral vector supernatant encoding the anti-MAGE-A3-DP4 TCR.
  • The study will begin in a standard phase 1 dose escalation. After the maximum tolerated dose (MTD) cell dose has been determined, patients will be enrolled into the phase 2 portion of the trial at the MTD established during the phase 1 portion of the study. In the phase 2 portion, patients will be entered into two cohorts: cohort 1 will include patients with metastatic melanoma; cohort 2 will include patients with renal cancer and other types of metastatic cancer.
  • Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of ex vivo tumor reactive, TCR gene-transduced peripheral blood mononuclear cells (PBMC) plus intravenous (IV) aldesleukin.
  • Patients will undergo complete evaluation of tumor response every 1-6 months until off study criteria are met.
  • For each of the 2 strata evaluated in the phase 2 portion, the study will be conducted using a phase 2 optimal design where initially 21 evaluable patients will be enrolled. For each of these two arms of the trial, if 0 or 1 of the 21 patients experiences a clinical response, then no further patients will be enrolled but if 2 or more of the first 21 evaluable patients enrolled have a clinical response, then accrual will continue until a total of 41 evaluable patients have been enrolled in that stratum.
  • For both strata, the objective will be to determine if the treatment regimen is able to be associated with a clinical response rate that can rule out 5% (p0=0.05) in favor of a modest 20% partial response (PR) + complete response (CR) rate (p1=0.20).
02

Conditions studied

  • Cervical Cancer
  • Renal Cancer
  • Urothelial Cancer
  • Melanoma
  • Breast Cancer

Keywords

  • Gene Therapy
  • Tumor Regression
  • Immunotherapy
  • Adoptive Cell Therapy
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 883 are open to participants now.

This study's enrollment of 21 is below the median of 54 across 2,765 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Metastatic or locally advanced refractory/recurrent cancer that expresses Melanoma antigen family A, 3 (MAGE-A3) as assessed by one of the following methods: Reverse transcription polymerase chain reaction (RT-PCR) on tumor tissue defined as 30,000 copies of MAGE-A3 per 10\^6 glyceraldehyde 3-phosphate dehydrogenase (GAPDH) copies, or by immunohistochemistry of resected tissue defined as 10% or greater of tumor cells being 2-3+ for MAGE-A3, or serum antibody reactive with MAGE-A3. Metastatic cancer diagnosis will be confirmed by the Laboratory of Pathology at the National Cancer Institute (NCI).
  2. Patients must have previously received prior first line standard therapy (or effective salvage chemotherapy regimens) for their disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred.
  3. Patients must be human leucocyte antigen (HLA)-DP4 positive.
  4. Patients with 3 or fewer brain metastases that are less than 1 centimeter (cm) in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.
  5. Greater than or equal to 18 years of age and less than or equal to age 70.
  6. Ability of subject to understand and the willingness to sign the Informed Consent Document.
  7. Willing to sign a durable power of attorney
  8. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1
  9. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment.

  10. Serology:

    • Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)
    • Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be hepatitis C hepatitis C virus (HCV) ribonucleic acid (RNA) negative.
  11. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus.

  12. Hematology

    • Absolute neutrophil count greater than 1000/mm\^3 without the support of filgrastim
    • White blood cell (WBC) greater than or equal to 3000/mm\^3
    • Platelets count greater than or equal to 100,000/mm\^3
    • Hemoglobin > 8.0 g/dl

  13. Chemistry:

    • Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than or equal to 2.5 times the upper limit of normal
    • Serum creatinine less than or equal to 1.6 mg/dl
    • Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.

  14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). Patients must have

    progressing disease after prior treatment. Note: Patients who have previously received ipilimumab and have documented gastrointestinal (GI) toxicity must have a normal colonoscopy with normal colonic biopsies.

  15. Subjects must be co-enrolled in protocol 03-C-0277.

Exclusion criteria

EXCLUSION CRITERIA:

  1. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
  2. Active systemic infections, (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses
  3. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
  4. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
  5. Concurrent systemic steroid therapy.
  6. History of severe immediate hypersensitivity reaction to any of the agents used in this study.
  7. History of any cardiac events including coronary revascularization or ischemic symptoms.

  8. Documented left ventricular ejection fraction (LVEF) of less than or equal to 45% testing is required in patients who are

    • greater than or equal to 65 years old
    • Clinically significant atrial and or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or have a history of ischemic heart disease, or chest pain.

  9. Documented forced expiratory volume (FEV1) less than or equal to 60% predicted tested in patients with:

    • A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2 years).
    • Symptoms of respiratory dysfunction
  10. Patients who are receiving any other investigational agents.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    1/Phase I Experimental Therapy

    Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + Anti-Melanoma antigen family A, 3 (MAGE-A3)-DP4 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + high-dose aldesleukin

    Biological: Anti-MAGE-A3-DP4 T Cell Receptor (TCR) Peripheral Blood Lymphocytes (PBL) · Drug: Cyclophosphamide · Drug: Fludarabine · Drug: Aldesleukin

  • Experimental
    2/Phase II Experimental Therapy

    Non-myeloablative lymphodepleting preparative regimen of cyclophosphamide and fludarabine + Anti-Melanoma antigen family A, 3 (MAGE-A3)-DP4 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + high-dose aldesleukin

    Biological: Anti-MAGE-A3-DP4 T Cell Receptor (TCR) Peripheral Blood Lymphocytes (PBL) · Drug: Cyclophosphamide · Drug: Fludarabine · Drug: Aldesleukin

Interventions

  • BiologicalAnti-MAGE-A3-DP4 T Cell Receptor (TCR) Peripheral Blood Lymphocytes (PBL)

    Day 0: cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes

  • DrugCyclophosphamide

    Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5 % in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hour.

    Also known as: Cytoxan

  • DrugFludarabine

    Days -7 to -3: Fludarabine 25 mg/m\^2 /day intravenous piggy-back (IVPB) daily over 30 minutes for 5 days.

    Also known as: Fludara

  • DrugAldesleukin

    Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).

    Also known as: Proleukin

06

What researchers measure

Primary outcomes

  1. Maximum Tolerated Cell Dose (MTD) of Cluster of Differentiation 4 (CD4) Cells Transduced With an Anti-MAGE-A3-DP0401/0402 Restricted (MAGE-A3-DP4) T Cell Receptor and Aldesleukin

    Highest dose at which less than or equal to 1 of 6 patients experienced a dose-limiting toxicity (DLT) (all grade 3 and greater toxicities with the exception of myelosuppression and grade 3 fever, for example) or the highest dose level studied if DLTs are not observed at any of the dose levels.

    Time frame: Before progression to next-higher dose level, at least two weeks

  2. Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)

    Percentage of participants who have a clinical response to treatment (objective tumor regression) measured by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter of target lesions. Progression is at least a 20% increase in the sum of longest diameter of target lesions or the appearance of one or more new lesions. And stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.

    Time frame: 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x2 years, then per principal investigator discretion, approximately 6 years

  3. Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment

    Aggregate of all adverse events with Grades ≥1 that are possibly, probably, and/or definitely related to treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse events.

    Time frame: 6 weeks after cell infusion

Secondary outcomes

  1. Number of Engineered T Cell Receptor (TCR) Cells That Survived at 4 Weeks

    T cell receptor (TCR) and vector presence was quantitated in peripheral blood mononuclear cells (PBMC) samples using flow cytometry. It is a process by which cells are suspended in a liquid so they can be counted.

    Time frame: 4 weeks

Other outcomes

  1. Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).

    Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

    Time frame: Date treatment consent signed to date off study, an average of 17 months

  2. Number of Participants With Dose-limiting Toxicity (DLT)

    A dose-limiting toxicity (DLT) is all grade 3 and greater toxicities with the exception of myelosuppression, aldesleukin expected toxicities, expected chemotherapy toxicities, immediate hypersensitivity reactions occurring within 2 hours of cell infusion, grade 3 fever, grade 3 metabolic laboratory abnormalities without significant clinical sequela that resolve within grade 2 within 7 days, and grade 3 autoimmunity that resolves to less than or equal to a grade 2 autoimmune toxicity within 10 days.

    Time frame: Before progression to next-higher dose level, approximately 2 weeks

07

Results

Posted Mar 29, 2022

Participant flow

Phase 1 Dose Escalation
Participant flow — Phase 1 Dose Escalation
MilestonePhase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 OtherPhase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
Started11112111600
Completed11111111600
Not completed00001000000
Withdrew: Participant found to be ineligible and not treated.00001000000
Phase 2 Maximum Tolerated Dose
Participant flow — Phase 2 Maximum Tolerated Dose
MilestonePhase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 OtherPhase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
Started00000000051
Completed00000000051
Not completed00000000000

Outcome measures

PrimaryMaximum Tolerated Cell Dose (MTD) of Cluster of Differentiation 4 (CD4) Cells Transduced With an Anti-MAGE-A3-DP0401/0402 Restricted (MAGE-A3-DP4) T Cell Receptor and Aldesleukin

Highest dose at which less than or equal to 1 of 6 patients experienced a dose-limiting toxicity (DLT) (all grade 3 and greater toxicities with the exception of myelosuppression and grade 3 fever, for example) or the highest dose level studied if DLTs are not observed at any of the dose levels.

Time frame:
Before progression to next-higher dose level, at least two weeks
Reported as:
Number · cells
Maximum Tolerated Cell Dose (MTD) of Cluster of Differentiation 4 (CD4) Cells Transduced With an Anti-MAGE-A3-DP0401/0402 Restricted (MAGE-A3-DP4) T Cell Receptor and Aldesleukin
cellsAll Participants on Phase 1
Maximum Tolerated Cell Dose (MTD) of Cluster of Differentiation 4 (CD4) Cells Transduced With an Anti-MAGE-A3-DP0401/0402 Restricted (MAGE-A3-DP4) T Cell Receptor and Aldesleukin100,000,000,000
PrimaryPercentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)

Percentage of participants who have a clinical response to treatment (objective tumor regression) measured by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter of target lesions. Progression is at least a 20% increase in the sum of longest diameter of target lesions or the appearance of one or more new lesions. And stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.

Time frame:
6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x2 years, then per principal investigator discretion, approximately 6 years
Reported as:
Number · percentage of participants
Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)
percentage of participantsPhase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 OtherPhase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
Complete Response0000010000000
Partial Response0000000022.2200
Progression100100100100100010010077.880100
Stable Disease00000000000
PrimaryNumber of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment

Aggregate of all adverse events with Grades ≥1 that are possibly, probably, and/or definitely related to treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse events.

Time frame:
6 weeks after cell infusion
Reported as:
Number · adverse events
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
adverse eventsPhase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 OtherPhase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
Grade 2 Anemia - Probable00000000020
Grade 2 Anorexia - Probable00000000010
Grade 2 Anxiety - Probable00000000010
Grade 2 Blood bilirubin increased - Probable00000000010
Grade 2 Chills - Probable00000000020
Grade 2 Colitis, infectious (e.g., Clostridium difficile) - Probable000000000010
Grade 2 Cough - Possible00000000010
Grade 2 Creatinine increased - Probable00000000020
Grade 2 Diarrhea - Probable00000000010
Grade 2 Dyspnea - Probable00000000020
Grade 2 Epistaxis - Probable00000000010
Grade 2 Fatigue - Probable10000101020
Grade 2 Fever - Probable000000000020
Grade 2 Hemoglobin - Definite00000000030
Grade 2 Hypokalemia - Probable00000000020
Grade 2 Hypophosphatemia - Probable00000000030
Grade 2 Hypotension - Probable00001000120
Grade 2 Hypoxia - Probable00000000020
Grade 2 Laryngeal hemorrhage - Probable00000000010
Grade 2 Leukocytes (total white blood cell) - Definite00000000020
Grade 2 Lymphocyte count decreased - Probable00000000020
Grade 2 Lymphopenia - Definite00000000020
Grade 2 Nasal congestion - Probable00000000010
Grade 2 Nausea - Probable00000000010
Grade 2 Neutrophils/granulocytes - Definite00000000010
Grade 2 Pain: Head/Headache - Possible00000000010
Grade 2 Platelet count decreased - Probable00000000010
Grade 2 Platelets - Definite00000000020
Grade 2 Pruritis - Probable00000000010
Grade 2 Psychosis (hallucinations/delusions) - Probable00000000010
Grade 2 Purpura - Probable00000000010
Grade 2 Rash maculo-papular - Probable00000000010
Grade 2 Rash/desquamation - Possible00000000010
Grade 2 Rash/desquamation - Probable00000000010
Grade 2 Renal/Genitourinary - Other, renal insufficiency - Probable00000000100
Grade 2 Wheezing - Probable00000000010
Grade 2 White blood cell decreased - Probable00000000030
Grade 3 SGPT (Serum glutamic pyruvic transaminase) - Possible00000000010
Grade 3 SGOT (Serum glutamic oxaloacetic transaminase) - Possible00000000010
Grade 3 SGOT (Serum glutamic oxaloacetic transaminase) - Probable00001000000
Grade 3 Anemia - Probable00000000050
Grade 3 Bilirubin (hyperbilirubinemia) - Possible00000000100
Grade 3 Confusion - Probable00000000100
Grade 3 Creatinine - Possible00000000010
Grade 3 Creatinine - Probable00001000000
Grade 3 Dyspnea (shortness of breath) - Possible00000000100
Grade 3 Dyspnea (shortness of breath) - Probable00000000020
Grade 3 Febrile neutropenia - Possible00000000010
Grade 3 Febrile neutropenia - Probable00000000010
Grade 3 Febrile neutropenia (fever of unknow origin) - Definite00000000010
Grade 3 Febrile neutropenia (fever of unknow origin) - Probable10000011221
Grade 3 Hemoglobin - Definite00000001661
Grade 3 Hemoglobin - Probable10120110000
Grade 3 Hypophosphatemia - Probable00000000020
Grade 3 Hypotension - Probable01000000020
Grade 3 Hypoxia - Possible00000000100
Grade 3 Hypoxia - Probable00000000010
Grade 3 Infection - Probable11101100310
Grade 3 Leukocytes (total white blood cell) - Definite00000000020
Grade 3 Lymphocyte count decreased - Probable00000000060
Grade 3 Lymphopenia - Definite00000000020
Grade 3 Neutrophil count decreased - Probable00000000040
Grade 3 Neutrophils/granulocytes - Definite00000000010
Grade 3 Neutrophils/granulocytes - Probable01000000000
Grade 3 PTT (Partial Thromboplastin Time) - Probable00001000000
Grade 3 Platelet count decreased - Probable00000000030
Grade 3 Platelets - Definite00000000030
Grade 3 Platelets - Probable01100000000
Grade 3 Potassium, serum-low (hypokalemia) - Possible00000000010
Grade 3 Psychosis (hallucinations/delusions) - Possible00000010000
Grade 3 Rash/desquamation - Possible00000000010
Grade 3 Renal failure - Probable00001010100
Grade 3 Renal/Genitourinary - Other, oliguria - Probable00010010100
Grade 3 Sodium, serum-low (hyponatremia) - Probable00000000100
Grade 3 Supraventricular and nodal arrhythmia: Atrial fibrillation - Possible00001000000
Grade 3 Supraventricular and nodal arrhythmia: Atrial fibrillation - Probable00000000200
Grade 3 Urine output decreased - Probable00000000010
Grade 3 White blood cell decreased - Probable00000000040
Grade 4 SGPT (Serum glutamic pyruvic transaminase) - Probable00000000100
Grade 4 SGOT (Serum glutamic oxaloacetic transaminase) - Probable00000000100
Grade 4 Creatinine - Probable00000000100
Grade 4 Dyspnea (shortness of breath) - Probable00000000100
Grade 4 Hemoglobin - Probable01001000000
Grade 4 Hypoxia - Probable00000000100
Grade 4 Leukocytes (total white blood cell) - Definite00000000010
Grade 4 Leukocytes (total white blood cell) - Probable11112000000
Grade 4 Lymphocyte count decreased - Probable00000000030
Grade 4 Lymphopenia - Definite00000001641
Grade 4 Lymphopenia - Probable11112110000
Grade 4 Neutrophil count decreased - Probable00000000020
Grade 4 Neutrophils/granulocytes - Definite00000001631
Grade 4 Neutrophils/granulocytes - Probable10112110000
Grade 4 Platelet count decreased - Probable00000000030
Grade 4 Platelets - Definite00000001621
Grade 4 Platelets - Probable10012110000
Grade 4 White blood cell decreased - Probable00000000020
SecondaryNumber of Engineered T Cell Receptor (TCR) Cells That Survived at 4 Weeks

T cell receptor (TCR) and vector presence was quantitated in peripheral blood mononuclear cells (PBMC) samples using flow cytometry. It is a process by which cells are suspended in a liquid so they can be counted.

Time frame:
4 weeks
Reported as:
Median · cells/uL
Number of Engineered T Cell Receptor (TCR) Cells That Survived at 4 Weeks
cells/uLPhase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 OtherPhase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
Number of Engineered T Cell Receptor (TCR) Cells That Survived at 4 Weeks1.0792 (NA to NA)1.9656 (NA to NA)2.8676 (NA to NA)—0.17248 (NA to NA)2.8 (NA to NA)0 (0 to 0)6.79 (NA to NA)31.9 (2.99 to 142.1)84.86 (11.32 to 158.41)24.95 (NA to NA)
Other pre-specifiedNumber of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Time frame:
Date treatment consent signed to date off study, an average of 17 months
Reported as:
Count of participants · Participants
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).
ParticipantsPhase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 OtherPhase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).11112111651
Other pre-specifiedNumber of Participants With Dose-limiting Toxicity (DLT)

A dose-limiting toxicity (DLT) is all grade 3 and greater toxicities with the exception of myelosuppression, aldesleukin expected toxicities, expected chemotherapy toxicities, immediate hypersensitivity reactions occurring within 2 hours of cell infusion, grade 3 fever, grade 3 metabolic laboratory abnormalities without significant clinical sequela that resolve within grade 2 within 7 days, and grade 3 autoimmunity that resolves to less than or equal to a grade 2 autoimmune toxicity within 10 days.

Time frame:
Before progression to next-higher dose level, approximately 2 weeks
Reported as:
Count of participants · Participants
Number of Participants With Dose-limiting Toxicity (DLT)
ParticipantsPhase 1
Number of Participants With Dose-limiting Toxicity (DLT)0

Adverse events

Collected over Date treatment consent signed to date off study, an average of 17 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-21/1 (100%)0/1 (0%)1/1 (100%)
Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-21/1 (100%)0/1 (0%)1/1 (100%)
Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-20/1 (0%)0/1 (0%)1/1 (100%)
Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-21/1 (100%)0/1 (0%)1/1 (100%)
Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-21/2 (50%)0/2 (0%)2/2 (100%)
Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-20/1 (0%)0/1 (0%)1/1 (100%)
Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-21/1 (100%)1/1 (100%)1/1 (100%)
Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-21/1 (100%)0/1 (0%)1/1 (100%)
Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-25/6 (83.3%)3/6 (50%)6/6 (100%)
Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other4/5 (80%)3/5 (60%)5/5 (100%)
Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma1/1 (100%)1/1 (100%)1/1 (100%)
Most frequent serious events
Showing 10 of 19
Most frequent serious events
EventPhase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 OtherPhase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
Febrile neutropeniaBlood and lymphatic system disorders0/10/10/10/10/20/11/10/11/62/51/1
HemoglobinInvestigations0/10/10/10/10/20/11/10/10/61/50/1
Psychosis (hallucinations/delusions)Psychiatric disorders0/10/10/10/10/20/11/10/10/60/50/1
Renal failureRenal and urinary disorders0/10/10/10/10/20/11/10/11/60/50/1
Renal/Genitourinary - Other (Oliguria)Renal and urinary disorders0/10/10/10/10/20/11/10/10/60/50/1
Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders0/10/10/10/10/20/10/10/12/61/50/1
HypoxiaRespiratory, thoracic and mediastinal disorders0/10/10/10/10/20/10/10/12/61/50/1
Supraventricular and nodal arrhythmia: Atrial fibrillationCardiac disorders0/10/10/10/10/20/10/10/12/60/50/1
ALT, SGPT (serum glutamic pyruvic transaminase)Investigations0/10/10/10/10/20/10/10/11/61/50/1
AST, SGOT (serum glutamic oxaloacetic transaminase)Investigations0/10/10/10/10/20/10/10/11/61/50/1
Most frequent other events
Showing 10 of 51
Most frequent other events
EventPhase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 OtherPhase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
Fatigue (asthenia, lethargy, malaise)General disorders1/10/10/10/10/21/10/11/10/61/50/1
Febrile neutropeniaBlood and lymphatic system disorders1/10/10/10/10/20/10/11/11/61/50/1
HemoglobinInvestigations1/11/11/11/11/21/10/11/16/63/51/1
HypotensionVascular disorders0/11/10/10/11/20/10/10/11/63/50/1
InfectionInfections and infestations1/11/11/10/11/21/10/10/12/60/50/1
Leukocytes (total WBC)Investigations1/11/11/11/12/20/10/10/10/61/50/1
LymphopeniaInvestigations1/11/11/11/12/21/11/11/16/63/51/1
Neutrophils/granulocytes (ANC/AGC)Investigations1/11/11/11/12/21/11/11/16/63/51/1
PlateletsInvestigations1/11/11/11/12/21/11/11/16/63/51/1
Potassium, serum-low (hypokalemia)Metabolism and nutrition disorders0/10/10/10/10/20/10/10/10/60/51/1

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 OtherPhase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 MelanomaTotal
<=18 years000000000000
Between 18 and 65 years1111211145119
>=65 years000000002002
Age, Continuous
Age, Continuous(years)Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 OtherPhase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 MelanomaTotal
Mean64 ± 063.2 ± 059.3 ± 045.9 ± 056.9 ± 1.5627.7 ± 044 ± 035.2 ± 056.03 ± 8.0841.84 ± 15.4841.8 ± 049.54 ± 12.69
Sex: Female, Male
Sex: Female, Male(Participants)Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 OtherPhase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 MelanomaTotal
Female0110111041010
Male1001100124111
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 OtherPhase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 MelanomaTotal
Hispanic or Latino000000000011
Not Hispanic or Latino1111211164019
Unknown or Not Reported000000000101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 OtherPhase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 MelanomaTotal
American Indian or Alaska Native000000000000
Asian000000000000
Native Hawaiian or Other Pacific Islander000000000000
Black or African American000000000000
White1111211165020
More than one race000000000000
Unknown or Not Reported000000000011
Region of Enrollment
Region of Enrollment(participants)Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 OtherPhase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 MelanomaTotal
United States1111211165121
08

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
09

References and documents

Publications

  • Morgan RA, Dudley ME, Yu YY, Zheng Z, Robbins PF, Theoret MR, Wunderlich JR, Hughes MS, Restifo NP, Rosenberg SA. High efficiency TCR gene transfer into primary human lymphocytes affords avid recognition of melanoma tumor antigen glycoprotein 100 and does not alter the recognition of autologous melanoma antigens. J Immunol. 2003 Sep 15;171(6):3287-95. doi: 10.4049/jimmunol.171.6.3287. PubMed 12960359 ↗
  • Suri A. Cancer testis antigens--their importance in immunotherapy and in the early detection of cancer. Expert Opin Biol Ther. 2006 Apr;6(4):379-89. doi: 10.1517/14712598.6.4.379. PubMed 16548764 ↗
  • Robbins PF, Morgan RA, Feldman SA, Yang JC, Sherry RM, Dudley ME, Wunderlich JR, Nahvi AV, Helman LJ, Mackall CL, Kammula US, Hughes MS, Restifo NP, Raffeld M, Lee CC, Levy CL, Li YF, El-Gamil M, Schwarz SL, Laurencot C, Rosenberg SA. Tumor regression in patients with metastatic synovial cell sarcoma and melanoma using genetically engineered lymphocytes reactive with NY-ESO-1. J Clin Oncol. 2011 Mar 1;29(7):917-24. doi: 10.1200/JCO.2010.32.2537. Epub 2011 Jan 31. PubMed 21282551 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 22, 2018
  • Informed consent form · Jun 27, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02111850
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Steven Rosenberg, M.D. (Principal Investigator, National Cancer Institute (NCI)) — Principal investigator
First posted
Apr 11, 2014
Start date
Feb 7, 2014
Primary completion
Mar 24, 2021
Completion
Mar 24, 2021
Results posted
Mar 29, 2022
Last update
Mar 29, 2022

Study contacts

Steven A Rosenberg, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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