Condition or disease | Intervention/treatment | Phase |
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B Cell Lymphoma Acute Lymphoblastic Leukemia | Genetic: Third generation CAR-T cells | Phase 1 |
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. CAR consists of single chain variable fragment (scFv) and activation domain of T cell. In preclinical study, the researchers constructed a third generation CAR containing CD137 and CD28 costimulatory domains.
This study aims to evaluate the safety and effectiveness of anti-CD22 CAR-T cells in patients with relapsed or refractory B-cell Malignancies.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Anti-CD22 CAR-T Therapy in Patients With Relapsed/Refractory B-cell Malignancies: a Single-center, Open-label, Single-arm Clinical Study |
Actual Study Start Date : | August 5, 2019 |
Estimated Primary Completion Date : | June 30, 2022 |
Estimated Study Completion Date : | December 30, 2022 |
Arm | Intervention/treatment |
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Experimental: Third generation CAR-T cells
Patients receive CD22 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity.
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Genetic: Third generation CAR-T cells
Patients receive CD22 CAR-T cells transduced with a lentiviral vector on day 0 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:
Pathological and histological examination confirmed CD22+ B-cell malignancies, and patients met the following criteria for refractory or relapsed B-cell malignancies.
A.Refractory/relapsed B-cell lymphoblastic leukemia (Meeting one of the following)
i. Recurrence within 6 months after first remission.
ii. Primary refractory disease which cannnot achieve complete remission (CR) after 2 cycles of standardized chemotherapy regimen.
iii. Failure to achieve CR or relapse after one line or multiple lines of salvage chemotherapy.
iv. Not suitable for hematopoietic stem cell transplantation (HSCT), or abandon HSCT due to various restrictions, or relapse after HSCT.
B.Refractory/relapsed B-cell lymphoma (Meeting 1 of the first 4 items plus item 5)
i. Tumor shrinkage less than 50% or disease progression after 4 cycles of standard chemotherapy.
ii. Achieved CR after standard chemotherapy, but relapsed within 6 months.
iii. 2 or more relapses after CR.
iv. Not suitable for HSCT, or abandon HSCT due to various restrictions, or relapse after HSCT.
v. Subjects must have received adequate treatment in the past, including anti-CD20 monoclonal antibody and combination chemotherapy with anthracyclines.
B-cell malignancies include the following three types
A. B-cell acute lymphoblastic leukemia (B-ALL)
B. Indolent B-cell lymphoma (CLL, FL, MZL, LPL, HCL)
C. Invasive B-cell lymphoma (DLBCL, BL, MCL)
Having a measurable or evaluable lesion
A. Patients with lymphoma require a single lesion≥15mm or 2 or more lesions≥10mm.
B. Patients with leukemia require persistent positive or positive relapse of bone marrow MRD.
Patient's main organs functioning well
A. Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin≤34.2μmol/L
B. Renal function: Creatinine < 220μmol/L.
C. Pulmonary function: Indoor oxygen saturation≥95%.
D. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥40%.
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 | June 28, 2019 | ||||||||
First Posted Date ICMJE | July 5, 2019 | ||||||||
Last Update Posted Date | August 7, 2019 | ||||||||
Actual Study Start Date ICMJE | August 5, 2019 | ||||||||
Estimated Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Number of participants with adverse events [ Time Frame: 3 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 | Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy for Relapsed Refractory B-cell Malignancies | ||||||||
Official Title ICMJE | Efficacy and Safety of Anti-CD22 CAR-T Therapy in Patients With Relapsed/Refractory B-cell Malignancies: a Single-center, Open-label, Single-arm Clinical Study | ||||||||
Brief Summary | This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of anti-CD22 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. CAR consists of single chain variable fragment (scFv) and activation domain of T cell. In preclinical study, the researchers constructed a third generation CAR containing CD137 and CD28 costimulatory domains. This study aims to evaluate the safety and effectiveness of anti-CD22 CAR-T cells in patients with relapsed or refractory B-cell Malignancies. |
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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: Third generation CAR-T cells
Patients receive CD22 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity.
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Study Arms ICMJE | Experimental: Third generation CAR-T cells
Patients receive CD22 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity.
Intervention: Genetic: Third generation 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 |
50 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 30, 2022 | ||||||||
Estimated Primary Completion Date | June 30, 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 | NCT04007978 | ||||||||
Other Study ID Numbers ICMJE | WHUH-CART-CD22-01 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | MEI HENG, Wuhan Union Hospital, China | ||||||||
Study Sponsor ICMJE | Wuhan Union Hospital, China | ||||||||
Collaborators ICMJE | Wuhan Bio-Raid Biotechnology Co., Ltd. | ||||||||
Investigators ICMJE |
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PRS Account | Wuhan Union Hospital, China | ||||||||
Verification Date | August 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |