Safety and Efficacy Study of Chimeric Antigen Receptor T (CAR-T) Cells in the Treatment of Relapsed/Refractory Hematological Malignancies

NCT05528887 Phase 1 RECRUITING

The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed/refractory hematological malignancies.

Details

Lead sponsor	The Affiliated People's Hospital of Ningbo University
Phase	Phase 1
Status	RECRUITING
Enrolment	10
Start date	2021-09-16
Completion	2026-06

Conditions

• Relapsed/Refractory Hematological Malignancies
• Lymphoma
• Myeloma
• Leukemia

Interventions

• Autologous CAR-T cells
• Fludarabine
• Cyclophosphamide

Primary outcomes

• TEAEs — 4 weeks
  Incidence and severity of Treatment Emergent Adverse Event.
• TRAEs — 4 weeks
  Incidence and severity of Treatment Related Adverse Events.
• AESIs — 4 weeks
  Incidence and severity of AEs of Special Interest.

Countries

China