Condition or disease | Intervention/treatment | Phase |
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Acute Lymphoblastic Leukemia B Cell Lymphoma | Genetic: Second generation humanized CAR-T cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Relapsed or Refractory B-cell Malignancies by Humanized CD19 Chimeric Antigen Receptor (CAR)-Modified T Cells |
Actual Study Start Date : | May 27, 2019 |
Estimated Primary Completion Date : | July 1, 2022 |
Estimated Study Completion Date : | December 31, 2022 |
Arm | Intervention/treatment |
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Experimental: Second generation humanized CAR-T cells
Patients receive humanized CD19 CAR-T cells transduced with a lentiviral vector on days 0/1/2 in the absence of disease progression or unacceptable toxicity.
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Genetic: Second generation humanized CAR-T cells
Patients receive humanized CD19 CAR-T cells transduced with a lentiviral vector on days 0/1/2 in the absence of disease progression or unacceptable toxicity.
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Ages Eligible for Study: | 14 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
B cell hematological malignancies include the following three categories:
A. B-cell acute lymphocytic leukemia (B-ALL);
B. Indolent B-cell lymphoma (CLL, FL, MZL, LPL);
C. Aggressive B-cell lymphoma (DLBCL, BL, MCL);
Exclusion Criteria:
Contact: Yu Hu, M.D., Ph.D | 86-13986183871 | dr_huyu@126.com | |
Contact: Heng Mei, M.D., Ph.D | 86-13886160811 | hmei@hust.edu.cn |
China, Hubei | |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting |
Wuhan, Hubei, China, 430022 | |
Contact: Yu Hu, M.D., Ph.D 86-13986183871 dr_huyu@126.com | |
Contact: Heng Mei, M.D., Ph.D 86-13886160811 hmei@hust.edu.cn |
Principal Investigator: | Heng Mei, M.D., Ph.D | Wuhan Union Hospital, China |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 1, 2019 | ||||||||
First Posted Date ICMJE | July 5, 2019 | ||||||||
Last Update Posted Date | August 7, 2019 | ||||||||
Actual Study Start Date ICMJE | May 27, 2019 | ||||||||
Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Number of participants with adverse events [ Time Frame: 5 years ] Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Humanized CD19 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With B-cell Malignancies | ||||||||
Official Title ICMJE | Treatment of Relapsed or Refractory B-cell Malignancies by Humanized CD19 Chimeric Antigen Receptor (CAR)-Modified T Cells | ||||||||
Brief Summary | This is a single arm, open-label study to evaluate the safety and efficacy of humanized anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies. | ||||||||
Detailed Description | Chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) have the capabilities to recognize tumor associated antigen and kill tumor cells specifically. CAR-T therapy showed great effect on patients with relapsed or refractory B cell malignancies. To improve the efficacy and safety, the researchers designed a second-generation humanized CAR, consisting of humanized CD19 single chain variable fragment (scFv) and CD137 costimulatory domain. This study aims to evaluate the safety and effectiveness of humanized anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
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 | Genetic: Second generation humanized CAR-T cells
Patients receive humanized CD19 CAR-T cells transduced with a lentiviral vector on days 0/1/2 in the absence of disease progression or unacceptable toxicity.
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Study Arms ICMJE | Experimental: Second generation humanized CAR-T cells
Patients receive humanized CD19 CAR-T cells transduced with a lentiviral vector on days 0/1/2 in the absence of disease progression or unacceptable toxicity.
Intervention: Genetic: Second generation humanized CAR-T cells
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Publications * | Not Provided | ||||||||
* 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 | Recruiting | ||||||||
Estimated Enrollment ICMJE |
10 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2022 | ||||||||
Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 14 Years to 70 Years (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04008251 | ||||||||
Other Study ID Numbers ICMJE | CART-huCD19-01 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Wuhan Sian Medical Technology Co., Ltd | ||||||||
Study Sponsor ICMJE | Wuhan Sian Medical Technology Co., Ltd | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Wuhan Sian Medical Technology Co., Ltd | ||||||||
Verification Date | July 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |