NCT03881774

Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies

Clinical Study of Cord Blood Derived CAR-T Cells in Patients With Refractory/Relapsed B Cell Leukemia/Lymphoma Who Are Failed for Autologous CAR-T Cells or Autologous CAR-T Can Not be Prepared

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 4 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Evaluation the safety and efficacy of cord blood-derived CAR-T cells in patients with relapsed/refractory B cell leukemia/lymphoma whose disease relapsed after autologous CAR-T cells therapy or who fail to preparation for autologous CAR-T cells

Detailed description

CAR-T cells therapy is the preferred option for relapsed/refractory B cell leukemia/lymphoma. However, some patients will relapse after CAR-T cells therapy, and because of previous multicycles chemotherapy it's very difficult to abtain enough lymphocytes for preparation of antologous CAR-T cells. The exploration of alternative source of lymphocytes for CAR-T cells preparation has important clinical implications for such patients. We evaluated the efficacy and safety of cord blood-derived CAR-T cells in such patients, and to explore effective treatment options for such patients.

Conditions

• Refractory
• Relapsed
• B Cell Lymphoma
• B Cell Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CAR-T cells	collecting cord blood for CAR-T cells culture; three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CAR-T cell with a dose of 0.5-3x106/kg

Timeline

• Start date: 2019-02-27
• Primary completion: 2021-01-31
• Completion: 2022-01-31
• First posted: 2019-03-19
• Last updated: 2019-03-21

Locations

2 sites across 1 country: China