NCT05596266

CD5 CAR-T Therapy for Refractory/Relapsed CD5+ T-cell Acute Lymphoblastic Leukemia

A Phase I Study of CD5 CAR-T for Refractory/Relapsed CD5+ T-ALL Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, interventional, single arm, open label, clinical study to evaluate the safety and tolerability of CD5 CAR-T cells in refractory/relapsed CD5+ T-ALL patients who have no available curative treatment options.

Detailed description

T-acute lymphoblast leukemia (T-ALL) is a neoplastic lymphoid leukemia characterized by the proliferation of immature precursor T cells. The combined chemotherapy has significantly improved the prognosis of T-acute lymphoblast leukemia/lymphoma. However, once the disease appears to be relapsed/refractory, there is limited treatment options, and the overall prognosis is extremely poor. Therefore, exploring safe and effective treatments is a critical unmet medical need. The patients will receive infusion of CAR T-cells targeting CD5 to examine the safety and, possibly the efficacy of CD5 CAR T-Cells in CD5+ relapsed or refractory acute leukemia.

Conditions

• T-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CD5 CAR-T	CD5 CAR-T will be administered by I.V. infusion.

Timeline

• Start date: 2022-10-25
• Primary completion: 2024-12-31
• Completion: 2025-10-25
• First posted: 2022-10-27
• Last updated: 2022-10-27

Locations

1 site across 1 country: China