CD4-specific CAR T Cells (CD4 CAR T Cells) for Relapsed/Refractory T Cell Malignancies

iCell Gene Therapeutics

Status and phase: Unknown; Phase 1

Conditions: T Cell Lymphoma in Relapse; Refractory T-Cell Lymphoma

Treatments: Biological: CD4 CAR T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04162340

ICG155-001

Details and patient eligibility

About

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD4 CAR T cells in patients with relapsed and/or refractory T cell lymphoma.

Full description

CD4-specific CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD4 antigen. CD4+ T cell lymphomas are a subset of leukemias and lymphomas that are positive for the surface protein CD4. The purpose of this study is to evaluate the efficacy and safety of CD4 CAR T cells.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed written informed consent; Patients volunteer to participate in the research
• Diagnosis is mainly based on the World Health Organization (WHO) 2008
• Patients have exhausted standard therapeutic options
• Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
• Female must be not pregnant during the study

Exclusion criteria

• Patients declining to consent for treatment
• Prior solid organ transplantation
• Potentially curative therapy including chemotherapy or hematopoietic cell transplant
• Any drug used for GVHD must be stopped >1 week

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 1 patient group

CD4 CAR T cells

Experimental group

Description:

Dose escalation phase: CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells with an escalation approach, 2e6 to 5e6 CAR-T cells/kg

Treatment:

Biological: CD4 CAR T cells