TerminatedNCT01273181Updated Oct 28, 2015Results posted

MAGE-A3/12 Metastatic Cancer Treatment With Anti-MAGE-A3/12 TCR-Gene Engineered Lymphocytes

A Phase 1/2 interventional study of PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes and Aldesleukin in Metastatic Cancer, Metastatic Renal Cancer and Metastatic Melanoma, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-28.

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

Phase: Phase 1/2
Study type: Interventional
Enrollment: 9
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

Background:

MAGE-A3/12 is a type of protein commonly found on certain types of cancer cells, particularly in metastatic cancer. Researchers have developed a process to take lymphocytes (white blood cells) from cancer patients, modify them in the laboratory to target cancer cells that contain MAGE-A3/12, and return them to the patient to help attack and kill the cancer cells. These modified white blood cells are an experimental treatment, but researchers are interested in determining their safety and effectiveness as a possible treatment for cancers that involve MAGE-A3/12.

Objectives:

To evaluate the safety and effectiveness of anti-MAGE-A3/12 lymphocytes as a treatment for metastatic cancers that have not responded to standard treatment.

Eligibility:

Individuals at least 18 years of age who have been diagnosed with metastatic melanoma, renal cell cancer, or another type of metastatic cancer that has not responded to standard treatment.

Design:

Participants will be screened with a full medical history and physical examination, as well as blood and urine tests, tumor samples, and imaging studies.
Participants will have leukapheresis to collect enough white blood cells for modification in the laboratory.
Seven days before the start of anti-MAGE-A3/12 treatment, participants will have chemotherapy with cyclophosphamide and fludarabine to suppress the immune system in preparation for the treatment.
After the last dose of chemotherapy, participants will receive the anti-MAGE-A3/12 cells as an infusion for 20 to 30 minutes, followed by a dose of interleukin-2 to keep the anti-MAGE-A3/12 cells alive and active as long as possible. Participants will also receive filgrastim to encourage the production of blood cells.
Participants will remain in the hospital to be monitored for possible side effects, and after release from the hospital will have regular followup exams with blood samples and imaging studies to evaluate the effectiveness of the treatment....

Read the detailed description

Background

We have constructed a single retroviral vector that contains both alpha and beta chains of a T cell receptor (TCR) that recognizes the MAGE-A3/12 tumor antigen, which can be used to mediate genetic transfer of this TCR with high efficiency (> 30%) without the need to perform any selection.

In co-cultures with human leukocyte antigen serotype within HLA-A serotype group (HLA-A2) and MAGE-A3/12 double positive tumors, anti-MAGE-A3/12 TCR transduced T cells secreted significant amounts of Interferon (IFN)-gamma with high specificity.

Objectives:

Primary objectives:

Determine if the administration of anti-MAGE-A3/12 engineered peripheral blood lymphocytes and aldesleukin to patients following a nonmyeloablative but lymphoid depleting preparative regimen will result in clinical tumor regression in patients with metastatic cancer that expresses the MAGE-A3/12 antigen.
Determine the toxicity profile of this treatment regimen

Secondary objectives:

-Determine the in vivo survival of TCR gene-engineered cells.

Eligibility:

Patients who are human leukocyte antigen (HLA)-A*0201 positive and 18 years of age or older must have:

metastatic cancer whose tumors express the MAGE-A3/12 antigen;
previously received and have been a non-responder to or recurred following standard care for metastatic disease;

Patients may not have:

-contraindications for high dose aldesleukin administration.

Design:

PBMC obtained by leukapheresis (approximately 10\^10) cells) will be cultured in the presence of anti-CD3 (OKT3) and aldesleukin in order to stimulate T-cell growth.

Transduction is initiated by exposure of approximately 10\^7 to 5 X 10\^8 cells to retroviral vector supernatant containing the anti-MAGE-A3/12 TCR genes.

The study will begin by evaluating the safety of two ranges of cells, 5 x 10\^9 - 3 x 10\^10, and greater than 3 x 10\^10- 1 x 10\^11 in a standard phase I dose escalation fashion using a 3+3 design. Once this safety has been confirmed, patients will be enrolled into the phase 2 portion of the trial using up to 1 x 10\^11 cells. In the phase 2 portion, patients will be entered into two cohorts based on histology: cohort 1 will include patients with metastatic melanoma or renal cell cancer; cohort 2 will include patients with 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 (720,000 IU/kg every (q)8h for a maximum of 15 doses).

Patients will undergo complete evaluation of tumor with physical examination, computed tomography (CT) of the chest, abdomen and pelvis and clinical laboratory evaluation four to six weeks after treatment. If the patient has stable disease (SD) or tumor shrinkage, repeat complete evaluations will be performed every 1-3 months. After the first year, patients continuing to respond will continue to be followed with this evaluation every 3-4 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 II 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 combination of high dose aldesleukin, lymphocyte depleting chemotherapy, and anti-MAGE-A3/12 TCR-gene engineered lymphocytes 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).

Conditions studied

Metastatic Cancer
Metastatic Renal Cancer
Metastatic Melanoma

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Keywords

Immunotherapy
Gene Therapy
Metastatic Cancer
Clinical Response
Metastatic Melanoma
Metastatic Renal Cell Cancer

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 9 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma 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.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Metastatic cancer that expresses MAGE-A3/12 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-A3/12 per 106 GAPDH copies, or by immunohistochemistry of resected tissue defined as 10% or greater of cells being 2-3+, or serum antibody reactive with MAGE-A3/12. Metastatic cancer diagnosis will be confirmed by the Laboratory of Pathology at the National Cancer Institute (NCI).

Patients with melanoma or renal cell cancer must have previously received high dose aldesleukin and have been either non-responders (progressive disease) or have recurred. Patients with other histologies, must have previously received at least one systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred.

Greater than or equal to 18 years of age.

Willing to sign a durable power of attorney

Able to understand and sign the Informed Consent Document

Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1.

Life expectancy of greater than three months.

Patients of both genders must be willing to practice birth control for four months after receiving the preparative regimen.

Patients must be human leukocyte antigen (HLA)-A*0201 positive

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 hepatitis C antibody unless antigen negative.

Hematology:

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

Chemistry:

Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less 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.

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).

Exclusion criteria

EXCLUSION CRITERIA:

Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.

Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.

Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).

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).

Concurrent Systemic steroid therapy

History of severe immediate hypersensitivity reaction to any of the agents used in this study.

History of coronary revascularization or ischemic symptoms

Any patient known to have an left ventricular ejection fraction (LVEF) less than or equal to 45%.

Documented LVEF of less than or equal to 45% tested in patients with:

History of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block
Age greater than or equal to 60 years old

Documented forced expiratory volume 1 (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

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 9 participants (actual)

Study arms

Experimental
Ph I:Anti-MAGE A3/12 TCR PBL 5x10e9
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV) Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes : Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days. Note for phase I: The study will begin by evaluating the safety of two ranges of cells, 5x10\^9-3x10\^10, and greater than 3x10\^10-1x10\^11 in a standard phase I dose escalation fashion using a 3+3 design.
Biological: PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes · Drug: Aldesleukin · Drug: Cyclophosphamide · Drug: Fludarabine
Experimental
Ph I:Anti-MAGE A3/12 TCR PBL 3x10e10
Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV) Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes : Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days. Note for phase I: The study will begin by evaluating the safety of two ranges of cells, 5x10\^9-3x10\^10, and greater than 3x10\^10-1x10\^11 in a standard phase I dose escalation fashion using a 3+3 design.
Biological: PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes · Drug: Aldesleukin · Drug: Cyclophosphamide · Drug: Fludarabine
Experimental
Ph II:Anti-MAGE TCR PBL MTD+HD IL-2
Phase II:Anti-MAGE A3/12 TCR PBL MTD + HD IL-2, Melanoma, RCC Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV) Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes : Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days. Note for phase II:patients will be entered into two cohorts based on histology:cohort 1 will include patients with metastatic melanoma or renal cell cancer; cohort 2 will include patients with other types of metastatic cancer.
Biological: PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes · Drug: Aldesleukin · Drug: Cyclophosphamide · Drug: Fludarabine
Experimental
Ph II:Anti-MAGE A3/12 TCR PBL MTD
Phase II: Anti-MAGE A3/12 TCR PBL MTD + HD-IL2 Other Cancer Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV) Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes : Fludarabine : 25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days. Note for phase II:patients will be entered into two cohorts based on histology:cohort 1 will include patients with metastatic melanoma or renal cell cancer; cohort 2 will include patients with other types of metastatic cancer.
Biological: PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes · Drug: Aldesleukin · Drug: Cyclophosphamide · Drug: Fludarabine

Interventions

BiologicalPG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes
DrugAldesleukin
720,000 IU/kg every 8 hours for a maximum of 15 doses
Also known as: IL-2
DrugCyclophosphamide
60 mg/kg/day x 2 days intravenous (IV)over 1 hour.
DrugFludarabine
25 mg/m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.

What researchers measure

Primary outcomes

Toxicity Profile
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time frame: 2 years
Clinical Tumor Regression (Complete Response (CR) + Partial Response (PR)) in Patients With Metastatic Cancer
Tumor regression response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Time frame: 2 years

Results

Posted Mar 27, 2013

Participant flow

Phase I, Dose 1

Participant flow — Phase I, Dose 1
Milestone	Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9	Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10	Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC	Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Started	3	0	0	0
Completed	2	0	0	0
Not completed	1	0	0	0
Withdrew: Study termination	1	0	0	0

Phase I, Dose 2

Participant flow — Phase I, Dose 2
Milestone	Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9	Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10	Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC	Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Started	0	3	0	0
Completed	0	2	0	0
Not completed	0	1	0	0
Withdrew: Death during treatment	0	1	0	0

Phase 2, Dose 1

Participant flow — Phase 2, Dose 1
Milestone	Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9	Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10	Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC	Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Started	0	0	2	0
Completed	0	0	1	0
Not completed	0	0	1	0
Withdrew: Study termination	0	0	1	0

Phase 2, Dose 2

Participant flow — Phase 2, Dose 2
Milestone	Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9	Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10	Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC	Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Started	0	0	0	1
Completed	0	0	0	0
Not completed	0	0	0	1
Withdrew: Death during treatment	0	0	0	1

Outcome measures

PrimaryToxicity Profile

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.

Time frame:: 2 years
Reported as:: Number · Participants

Toxicity Profile
Participants	Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9	Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10	Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC	Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Toxicity Profile	3	3	2	1

PrimaryClinical Tumor Regression (Complete Response (CR) + Partial Response (PR)) in Patients With Metastatic Cancer

Tumor regression response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.

Time frame:: 2 years
Reported as:: Number · Participants

Clinical Tumor Regression (Complete Response (CR) + Partial Response (PR)) in Patients With Metastatic Cancer
Participants	Anti-MAGE TCR PBL 5x10e9 +HD IL-2	Anti-MAGE TCR PBL 5x10e10 +HD IL-2	Anti-MAGE TCR PBL+HD IL-2, Mel, RCC	Anti-MAGE TCR PBL +HD IL-2, Other
Complete Response	1	0	0	0
Partial Response	1	2	0	0

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9	—	2/3 (66.7%)	3/3 (100%)
Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10	—	1/3 (33.3%)	3/3 (100%)
Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC	—	2/2 (100%)	2/2 (100%)
Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer	—	1/1 (100%)	1/1 (100%)

Most frequent serious events

Showing 10 of 16

Most frequent serious events
Event	Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9	Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10	Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC	Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
Somnolence/depressed level of consciousnessNervous system disorders	1/3	1/3	0/2	1/1
Death not associated with CTCAE termGeneral disorders	0/3	1/3	0/2	1/1
Renal failureRenal and urinary disorders	0/3	0/3	0/2	1/1
ALT/SGPT (serum glutamic pyruvic transaminase)Metabolism and nutrition disorders	2/3	0/3	0/2	0/1
AST/SGOT (serum glutamic oxaloacetic transaminase)Metabolism and nutrition disorders	2/3	0/3	0/2	0/1
SeizureNervous system disorders	0/3	1/3	1/2	0/1
Speech impairment (e.g. dysphasia or aphasia)Nervous system disorders	0/3	0/3	1/2	0/1
HypoxiaRespiratory, thoracic and mediastinal disorders	0/3	0/3	1/2	0/1
HemoglobinBlood and lymphatic system disorders	1/3	0/3	0/2	0/1
Left ventricular diastolic dysfunctionCardiac disorders	1/3	1/3	0/2	0/1

Most frequent other events

Showing 10 of 29

Most frequent other events
Event	Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9	Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10	Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC	Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer
HemoglobinBlood and lymphatic system disorders	1/3	2/3	2/2	1/1
Leukocytes (total WBC)Blood and lymphatic system disorders	3/3	3/3	2/2	1/1
LymphopeniaBlood and lymphatic system disorders	3/3	3/3	2/2	1/1
Neutrophils/granulocytes (ANC/AGC)Blood and lymphatic system disorders	3/3	3/3	2/2	1/1
PlateletsBlood and lymphatic system disorders	3/3	3/3	2/2	1/1
Febrile neutropeniaInfections and infestations	3/3	3/3	1/2	0/1
Albumin, serum-low (hypoalbuminemia)Metabolism and nutrition disorders	1/3	2/3	1/2	1/1
Phosphate, serum-low (hypophosphatemia)Metabolism and nutrition disorders	3/3	2/3	1/2	1/1
Potassium, serum-low (hypokalemia)Metabolism and nutrition disorders	1/3	0/3	0/2	1/1
Acute vascular leak syndromeVascular disorders	1/3	0/3	0/2	1/1

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9	Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10	Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC	Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	3	3	2	0	8
>=65 years	0	0	0	1	1

Age, Continuous
Age, Continuous(years)	Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9	Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10	Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC	Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer	Total
Mean	51.0 ± 11.4	39.7 ± 16.9	62.0 ± 0.0	71.0	51.9 ± 15.2

Sex: Female, Male
Sex: Female, Male(Participants)	Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9	Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10	Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC	Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer	Total
Female	2	1	1	1	5
Male	1	2	1	0	4

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9	Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10	Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC	Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer	Total
Hispanic or Latino	0	0	0	0	0
Not Hispanic or Latino	3	3	2	1	9
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9	Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10	Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC	Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	00	0	0	0
White	3	3	2	1	9
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9	Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10	Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC	Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer	Total
United States	3	3	2	1	9

Study locations

1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland 20892, United States

References and documents

Publications

Rosenberg SA. Progress in human tumour immunology and immunotherapy. Nature. 2001 May 17;411(6835):380-4. doi: 10.1038/35077246. PubMed 11357146 ↗
Berendt MJ, North RJ. T-cell-mediated suppression of anti-tumor immunity. An explanation for progressive growth of an immunogenic tumor. J Exp Med. 1980 Jan 1;151(1):69-80. doi: 10.1084/jem.151.1.69. PubMed 6444236 ↗
Gattinoni L, Powell DJ Jr, Rosenberg SA, Restifo NP. Adoptive immunotherapy for cancer: building on success. Nat Rev Immunol. 2006 May;6(5):383-93. doi: 10.1038/nri1842. PubMed 16622476 ↗
Abate-Daga D, Hanada K, Davis JL, Yang JC, Rosenberg SA, Morgan RA. Expression profiling of TCR-engineered T cells demonstrates overexpression of multiple inhibitory receptors in persisting lymphocytes. Blood. 2013 Aug 22;122(8):1399-410. doi: 10.1182/blood-2013-04-495531. Epub 2013 Jul 16. PubMed 23861247 ↗
Morgan RA, Chinnasamy N, Abate-Daga D, Gros A, Robbins PF, Zheng Z, Dudley ME, Feldman SA, Yang JC, Sherry RM, Phan GQ, Hughes MS, Kammula US, Miller AD, Hessman CJ, Stewart AA, Restifo NP, Quezado MM, Alimchandani M, Rosenberg AZ, Nath A, Wang T, Bielekova B, Wuest SC, Akula N, McMahon FJ, Wilde S, Mosetter B, Schendel DJ, Laurencot CM, Rosenberg SA. Cancer regression and neurological toxicity following anti-MAGE-A3 TCR gene therapy. J Immunother. 2013 Feb;36(2):133-51. doi: 10.1097/CJI.0b013e3182829903. PubMed 23377668 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01273181
Lead sponsor: National Cancer Institute (NCI)
Responsible party: Steven Rosenberg, M.D. (Principal Investigator, National Institutes of Health Clinical Center (CC)) — Principal investigator
First posted: Jan 10, 2011
Start date: Dec 2010
Primary completion: Dec 2012
Completion: Dec 2012
Results posted: Mar 27, 2013
Last update: Oct 28, 2015

Study contacts

Steven A Rosenberg, M.D.

principal investigator · National Cancer Institute (NCI)

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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