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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

CD4 CAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.

CD4 CAR T cells

Kevin Pinz, MS

Yupo Ma, MD/PhD

Hongyu Zhang, MD/PhD

Fang Liu, MD/PhD

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.

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.

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

Determine the toxicity profile of CD4 CAR T cell therapy

Incidence of treatment-emergent adverse events

Disease Free Survival (DFS) (IMWG criteria)

Progression-Free Survival (IMWG criteria)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CD4-specific CAR T Cells (CD4 CAR T Cells) for Relapsed/Refractory T Cell Malignancies	NCT04162340	T Cell Lymphoma... Refractory T-Ce...	CD4 CAR T cells	18 Years -	iCell Gene Therapeutics
CD4-specific CAR T Cells (CD4 CAR T Cells) for Relapsed/Refractory T Cell Malignancies	NCT04162340	T Cell Lymphoma... Refractory T-Ce...	CD4 CAR T cells	18 Years -	iCell Gene Therapeutics

Spots Global Cancer Trial Database for cd4 car t cells