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Status unknownNCT02685670MatchCARTUpdated Mar 16, 2017

Competitive Transfer of αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T Cells for B-cell Leukemia/Lymphoma

A Phase 1/2 interventional study of anti-CD19 CAR-T and Fludarabine in Hematopoietic/Lymphoid Cancer, Adult Acute Lymphoblastic Leukemia in Remission and B-cell Adult Acute Lymphoblastic Leukemia, sponsored by The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 5 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-03-16.

Sponsored by The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
5 Years to 70 Years
Sex
All
01

Study summary

This is a single-arm open-label phase I/II study to determine the relative superiority of αCD19-TCRζ-CD28 and αCD19-TCRζ-CD137 CAR-T Cells in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma. Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically against cancer cells, has emerged as a promising therapeutic strategy. Clinical trials utilizing CARs against B cell malignancies have demonstrated remarkable potential. In this trial, all subjects will be competitively infused with αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T cells in equal number to test a hypothesis that CD137-costimulation can promote the persistence and engraftment of CAR-T cells and this superiority can lead to improved progression-free survival.

Read the detailed description

Primary objectives

  1. To determine the safety and feasibility of adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma

Secondary objectives

  1. To measure the efficacy of anti-tumor responses after CD19CAR T cell infusion
  2. To determine if CD19CAR T cells engineered with 4-1BB signaling domain is superior to that with CD28 signaling domain for their homing and persistence after CD19CAR T cell infusion
02

Conditions studied

  • Hematopoietic/Lymphoid Cancer
  • Adult Acute Lymphoblastic Leukemia in Remission
  • B-cell Adult Acute Lymphoblastic Leukemia
  • B-cell Chronic Lymphocytic Leukemia
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Stage III Adult Diffuse Large Cell Lymphoma
  • Stage III Chronic Lymphocytic Leukemia
  • Stage III Grade 1 Follicular Lymphoma
  • Stage III Grade 2 Follicular Lymphoma
  • Stage III Grade 3 Follicular Lymphoma
  • Stage III Mantle Cell Lymphoma
  • Stage IV Adult Diffuse Large Cell Lymphoma
  • Stage IV Chronic Lymphocytic Leukemia
  • Stage IV Grade 1 Follicular Lymphoma
  • Stage IV Grade 2 Follicular Lymphoma
  • Stage IV Grade 3 Follicular Lymphoma
  • Stage IV Mantle Cell Lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine is the lead sponsor of 3 studies on the registry; none are open to participants now.

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

04

Who can participate

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

Inclusion criteria

  1. 5 Years to 70 Years, Male and female;
  2. Expected survival > 12 weeks;
  3. Performance score 0-2;
  4. Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions;

    • Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment;
    • Disease recurrence after stem cell transplantation;
    • Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy
  5. Creatinine \< 2.5 mg/dl;
  6. ALT/AST \< 3x normal;
  7. Bilirubin \< 2.0 mg/dl;
  8. Adequate venous access for apheresis, and no other contraindications for leukapheresis;
  9. Take contraceptive measures before recruit to this trial;
  10. Written voluntary informed consent is given.

Exclusion criteria

Exclusion Criteria:

  1. Patients with symptoms of central nervous system
  2. Accompanied by other malignant tumor
  3. Active hepatitis B or C, HIV infection
  4. Any other diseases could affect the outcome of this trial
  5. Suffering severe cardiovascular or respiratory disease
  6. Poorly controlled hypertension
  7. A history of mental illness and poorly controlled
  8. Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration
  9. Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
  10. Reaching a steady dose if receiving anticoagulant therapy before assignment
  11. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
  12. Pregnant or lactating women
  13. Subject suffering disease affects the understanding of informed consent or comply with study protocol.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Mixed CD19CAR transfer

    All subjects will be infused with αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T cells in equal number

    Biological: anti-CD19 CAR-T · Drug: Fludarabine · Drug: Cyclophosphamide

Interventions

  • Biologicalanti-CD19 CAR-T

    Ex vivo-expanded autologous T cells modified to express CD19 CAR

  • DrugFludarabine
  • DrugCyclophosphamide
06

What researchers measure

Primary outcomes

  1. Safety (incidence of adverse events defined as dose-limited toxicity)

    Time frame: 30 days

Secondary outcomes

  1. Overall complete remission rate

    Time frame: 8 weeks

  2. Survival of CAR T cells in circulation measured by flow cytometry and PCR

    Time frame: 1 year

  3. Duration of remission

    Time frame: 1 year

  4. Overall survival

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Henan Province of TCM
    Zhengzhou, Henan, China
    • Zhi Cheng, M.D. · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02685670
Lead sponsor
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Collaborators
Xinqiao Hospital of Chongqing, Xuzhou Medical University
Responsible party
Chengzhi (Director of Department of Hematology, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine) — Principal investigator
First posted
Feb 19, 2016
Start date
Feb 2016
Primary completion
Dec 2017 (estimated)
Completion
Dec 2019 (estimated)
Last update
Mar 16, 2017

Study contacts

Zhi Cheng, M.D.
Contact
clinicaltrials.chengzhi@outlook.com
+(86)-139-3852-6995
Zhi Cheng, M.D.
principal investigator · The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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