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

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

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.

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