NCT04767308

Safety and Efficacy of CT125A Cells for Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies

A Single-center, Single-arm Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Fully Human Anti-CD5 Chimeric Antigen Receptor T Cells (CT125A Cells) for the Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Current treatments for relapsed/refractory hematopoietic malignancies such as B-cell lymphomas (BCLs) and peripheral T-cell lymphomas (PTCLs) are far from satisfactory. CD5 is widely expressed in multiple subtypes of BCLs and PTCLs but rarely found in normal tissues except certain types of lymphocytes. Chimeric antigen receptor (CAR) T cells against CD5 offer another potential therapeutic option for patients with relapsed/refractory CD5 positive hematopoietic malignancies. In the current study, the safety and efficacy of a novel CAR T cell therapy, termed CT125A cells, are evaluated in patients with relapsed/refractory CD5+ hematopoietic malignancies. The endogenous CD5 in CT125A cells is knocked out via CRISPR/Cas9 genome editing technology to prevent fratricide during CAR T cells manufacturing.

Conditions

• CD5+ Relapsed/Refractory Hematopoietic Malignancies
• Chronic Lymphocytic Leukemia (CLL)
• Mantle Cell Lymphoma (MCL)
• Diffuse Large B-cell Lymphoma (DLBCL)
• Follicular Lymphoma (FL)
• Peripheral T-cell Lymphomas (PTCL)

Interventions

Type	Name	Description
BIOLOGICAL	CT125A cells	Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to manufacture CT125A cells, during which cyclophosphamide and fludarabine will be administered for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with CT125A cells by intravenous (IV) infusion. The initial dose of 1×10\^6 CAR+ T cells/kg will be infused on day 0.
DRUG	Cyclophosphamide, fludarabine	Subjects will be given IV infusion of cyclophosphamide 500 mg/m2/day and fludarabine 30 mg/m2/day on days -4, -3 and -2

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-09-01
• Completion: 2023-12-01
• First posted: 2021-02-23
• Last updated: 2021-02-23