NCT05528887

Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: The Affiliated People's Hospital of Ningbo University · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

CAR-T cells targeted CD19 have demonstrated unprecedented successes. Besides CD19, many other molecules such as CD123, BCMA, and CD7 may be potential in developing the corresponding CAR-T cells to treat patients with hematopoietic and lymphoid malignancies. UTC Therapeutics Inc. have developed an efficient platform for constructing CAR-T cells that can remodel of tumor microenvironment and enhance the anti-tumor immune response and persistence of CAR-T cells. In this study, all eligible subjects will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by investigational treatment, CAR-T cells. Safety and efficacy of the CAR-T cells will be assessed.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Autologous CAR-T cells	D0: CAR-T cells will be infused intravenously.
DRUG	Fludarabine	D-5 to D-3: Fludarabine (30 mg/m\^2/day) will be administered intravenously for 3 days.
DRUG	Cyclophosphamide	D-5 to D-3: Cyclophosphamide (500 mg/m\^2/day) will be administered intravenously for 3 days.

Timeline

• Start date: 2021-09-16
• Primary completion: 2024-06-01
• Completion: 2026-06-01
• First posted: 2022-09-06
• Last updated: 2022-09-06

Locations

1 site across 1 country: China