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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2023

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Number of adverse events after anti-CD5 CAR T cells cell infusion
    • Time Frame: 2 years particularly the first 28 days after infusion
    • Determine the toxicity profile of anti-CD5 CAR T cell therapy

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • iCell Gene Therapeutics
  • Collaborator
    • iCAR Bio Therapeutics Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hongyu Zhang, MD/PhD, Principal Investigator, Peking University Shenzhen Hospital, China
  • Overall Contact(s)
    • Kevin G Pinz, MS, 6315386218, kevin.pinz@icellgene.com

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