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NCT04594135 Clinical Trial

Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies

T-cell Acute Lymphoblastic Leukemia Clinical Trial

— CD5CAR-T  

Official title:
Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04594135
Other study ID # ICG190-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 1, 2020
Est. completion date November 30, 2023

Study information
Verified date February 2021
Source iCell Gene Therapeutics
Contact Kevin G Pinz, MS
Phone 6315386218
Email kevin.pinz@icellgene.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date November 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 8 Years and older
Eligibility Inclusion Criteria: 1. Signed written informed consent; Patients volunteer to participate in the research 2. Diagnosis is mainly based on the World Health Organization (WHO) 2008 3. Patients have exhausted standard therapeutic options 4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks 5. Female must be not pregnant during the study Exclusion Criteria: 1. Patients declining to consent for treatment 2. Prior solid organ transplantation 3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant 4. Any drug used for GVHD must be stopped >1 week

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Peking University Shenzhen Hospital Shenzhen Guangdong

Sponsors (3)
Lead Sponsor Collaborator
iCell Gene Therapeutics iCAR Bio, Peking University Shenzhen Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of adverse events after anti-CD5 CAR T cells cell infusion Determine the toxicity profile of anti-CD5 CAR T cell therapy 2 years particularly the first 28 days after infusion
Secondary Incidence of treatment-emergent adverse events Incidence of treatment-emergent adverse events up to 6 months
Secondary Disease Free Survival (DFS) Disease Free Survival (DFS) up to 2 years
Secondary Progression-Free Survival (PFS) Progression-Free Survival (PFS) up to 2 years
Secondary Overall Survival (OS) Overall Survival (OS) up to 2 years
See also
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Not yet recruiting NCT06420076 - Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells Phase 1/Phase 2
Recruiting NCT04033302 - Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies Phase 1/Phase 2
Recruiting NCT05995028 - Universal 4SCAR7U Targeting CD7-positive Malignancies Phase 1
Recruiting NCT05596266 - CD5 CAR-T Therapy for Refractory/Relapsed CD5+ T-cell Acute Lymphoblastic Leukemia Phase 1
Completed NCT01950286 - Hyper-CVAD Treatment of Adult T-cell Acute Lymphoblastic Leukemia in Sweden. N/A
Completed NCT02518113 - A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL Phase 1/Phase 2
Recruiting NCT03081910 - Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen Phase 1
Recruiting NCT05290155 - Anti-CD7 CAR-T Cell Therapy for Relapse and Refractory CD7 Positive T Cell Malignancies Phase 1
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Recruiting NCT04972942 - Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma Phase 1
Recruiting NCT06316427 - Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Acute Lymphoblastic Leukemia/Lymphoma Phase 1/Phase 2
Recruiting NCT05277753 - NGS-MRD Assessment of Combination Immunotherapies Targeting T-ALL Phase 1
Not yet recruiting NCT06390319 - Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL) Phase 2
Recruiting NCT05679895 - Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL Phase 1
Active, not recruiting NCT04984356 - A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL Phase 1/Phase 2
Recruiting NCT05832125 - Registry of Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia
Withdrawn NCT04860817 - A Study of Anti-CD7 CAR-T Cells in Pediatric and Young Adult Patients With Relapse and Refractory T-ALL/ T-LBL Early Phase 1
Recruiting NCT04934774 - Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances Phase 1
Enrolling by invitation NCT05509855 - A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007