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

Phase 1

• Conditions: T-cell Acute Lymphoblastic Leukemia; T-cell Non-Hodgkin Lymphoma
• Interventions: Drug: anti-CD5 CAR T cells

• Registration Number: NCT04594135
• Lead Sponsor: iCell Gene Therapeutics

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.

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 Timeline

• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-20
• Study Start: 2020-12-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-27
• Last Update Posted: 2021-03-02
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
anti-CD5 CAR T cells	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Disease Free Survival (DFS)	up to 2 years	Disease Free Survival (DFS)
Incidence of treatment-emergent adverse events	up to 6 months	Incidence of treatment-emergent adverse events
Progression-Free Survival (PFS)	up to 2 years	Progression-Free Survival (PFS)
Overall Survival (OS)	up to 2 years	Overall Survival (OS)

Trial Locations

Locations (1)

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China