CD5CAR-T: Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies
Study Details
Study Description
Brief Summary
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD5 CART cells in patients with relapsed and/or refractory T cell lymphoma or leukemia.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 1 |
Detailed Description
Anti- CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD5 antigen. CD5+ T cell lymphomas or leukemia are a subset of leukemias and lymphomas that are positive for the surface protein CD5. The purpose of this study is to evaluate the efficacy and safety of anti-CD5 CAR T cells.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: anti-CD5 CAR T cells Experimental: anti-CD5 CAR T cells Dose escalation phase: anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells with an escalation approach, 1e6 to 5e6 CAR-T cells/kg |
Drug: anti-CD5 CAR T cells
anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells
|
Outcome Measures
Primary Outcome Measures
- Number of adverse events after anti-CD5 CAR T cells cell infusion [2 years particularly the first 28 days after infusion]
Determine the toxicity profile of anti-CD5 CAR T cell therapy
Secondary Outcome Measures
- Incidence of treatment-emergent adverse events [up to 6 months]
Incidence of treatment-emergent adverse events
- Disease Free Survival (DFS) [up to 2 years]
Disease Free Survival (DFS)
- Progression-Free Survival (PFS) [up to 2 years]
Progression-Free Survival (PFS)
- Overall Survival (OS) [up to 2 years]
Overall Survival (OS)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed written informed consent; Patients volunteer to participate in the research
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Diagnosis is mainly based on the World Health Organization (WHO) 2008
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Patients have exhausted standard therapeutic options
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Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
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Female must be not pregnant during the study
Exclusion Criteria:
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Patients declining to consent for treatment
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Prior solid organ transplantation
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Potentially curative therapy including chemotherapy or hematopoietic cell transplant
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Any drug used for GVHD must be stopped >1 week
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Peking University Shenzhen Hospital | Shenzhen | Guangdong | China |
Sponsors and Collaborators
- iCell Gene Therapeutics
- iCAR Bio Therapeutics Ltd.
- Peking University Shenzhen Hospital
Investigators
- Principal Investigator: Hongyu Zhang, MD/PhD, Peking University Shenzhen Hospital, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ICG190-001