Treatment of Relapsed and/or Chemotherapy Refractory B-cell Malignancy by Tandem CAR T Cells Targeting CD19 and CD20
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|ClinicalTrials.gov Identifier: NCT03097770|
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : December 16, 2019
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells.
PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with B-cell leukemia or lymphoma that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic/Lymphoid Cancer Adult Acute Lymphoblastic Leukemia in Remission B-cell Adult Acute Lymphoblastic Leukemia B-cell Chronic Lymphocytic Leukemia Prolymphocytic 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||Biological: anti-CD19/20-CAR vector-transduced T cells||Phase 1 Phase 2|
To assess the efficacy of TanCAR19/20 T cells in relapsed or refractory NHL, defined as overall response rate (ORR).
I. To evaluate the safety and tolerability of TanCAR19/20 T cells. II. To evaluate time to response (TTR), duration of overall response (DOR), progression free survival (PFS) and overall survival (OS).
III. To determine in vivo expansion and persistence of TanCAR19/20 T cells.
OUTLINE: Patients are assigned to 1 group according to order of enrollment. Patients receive anti-CD19/20-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on day1 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of CD19/CD20 tanCAR T Cells in Relapsed and/or Chemotherapy Refractory B-cell Leukemias and Lymphomas|
|Actual Study Start Date :||April 1, 2017|
|Actual Primary Completion Date :||May 10, 2019|
|Estimated Study Completion Date :||April 30, 2020|
Experimental: anti-CD19/20 CAR T cells
Patients receive anti-CD19/20-CAR retroviral vector-transduced autologous or donor-derived T cells on day 1 in the absence of disease progression or unacceptable toxicity.
Biological: anti-CD19/20-CAR vector-transduced T cells
genetically engineered lymphocyte therapy
Other Name: genetically engineered lymphocyte therapy
- Occurrence of study related adverse events [ Time Frame: Until week 24 ]defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
- Anti-tumor responses to tanCART19/20 cell infusions [ Time Frame: up to 96 weeks ]
- In vivo existence of TanCART19/20 [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097770
|Contact: weidong han, Drfirstname.lastname@example.org|
|Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: weidong han, Dr 86-10-66937463 email@example.com|