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 :
Completed
First Posted : March 31, 2017
Last Update Posted : September 2, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | March 26, 2017 | ||||
First Posted Date ICMJE | March 31, 2017 | ||||
Last Update Posted Date | September 2, 2020 | ||||
Actual Study Start Date ICMJE | April 1, 2017 | ||||
Actual Primary Completion Date | May 10, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Anti-tumor responses to tanCART19/20 cell infusions [ Time Frame: up to 96 weeks ] | ||||
Original Secondary Outcome Measures ICMJE |
Anti-tumor responses to tanCART19/20 cell infusions [ Time Frame: up to 24 weeks ] | ||||
Current Other Pre-specified Outcome Measures |
In vivo existence of TanCART19/20 [ Time Frame: 2 years ] | ||||
Original Other Pre-specified Outcome Measures |
in vivo existence of tanCART19/20 [ Time Frame: 1 year ] | ||||
Descriptive Information | |||||
Brief Title ICMJE | Treatment of Relapsed and/or Chemotherapy Refractory B-cell Malignancy by Tandem CAR T Cells Targeting CD19 and CD20 | ||||
Official Title ICMJE | Clinical Study of CD19/CD20 tanCAR T Cells in Relapsed and/or Chemotherapy Refractory B-cell Leukemias and Lymphomas | ||||
Brief Summary | 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. |
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Detailed Description | PRIMARY OBJECTIVES: To assess the efficacy of TanCAR19/20 T cells in relapsed or refractory NHL, defined as overall response rate (ORR). SECONDARY OBJECTIVES: 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Biological: anti-CD19/20-CAR vector-transduced T cells
genetically engineered lymphocyte therapy
Other Name: genetically engineered lymphocyte therapy
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Study Arms ICMJE | 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.
Intervention: Biological: anti-CD19/20-CAR vector-transduced T cells
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Publications * | Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
100 | ||||
Original Estimated Enrollment ICMJE |
20 | ||||
Actual Study Completion Date ICMJE | January 31, 2020 | ||||
Actual Primary Completion Date | May 10, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria Patients eligible for inclusion in this study have to meet all of the following criteria:
Exclusion Criteria: Patients eligible for this study must not meet any of the following criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years to 70 Years (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03097770 | ||||
Other Study ID Numbers ICMJE | CHN-PLAGH-BT-020 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Han weidong, Chinese PLA General Hospital | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Chinese PLA General Hospital | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Chinese PLA General Hospital | ||||
Verification Date | December 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |