NCT05513612

Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies

Safety and Efficacy Study of Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shanghai Pudong Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 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 hematopoietic and lymphoid malignancies.

Detailed description

Chimeric antigen receptor (CAR)-modified 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, efficacy, pharmacokinetic, and pharmacodynamic of the CAR-T cells will be assessed.

Conditions

• Acute Myeloid Leukemia (AML)
• B-cell Non-Hodgkin's Lymphoma (B-NHL)
• Multiple Myeloma (MM)
• T-Cell Leukemia/Lymphoma, Adult
• B-cell Acute Lymphoblastic Leukemia (B-ALL)

Interventions

Type	Name	Description
BIOLOGICAL	Autologous CAR-T cells	CAR-T cells will be infused intravenously.
DRUG	Fludarabine	Administered according to package insert
DRUG	Cyclophosphamide	Administered according to package insert

Timeline

• Start date: 2020-08-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2022-08-24
• Last updated: 2023-03-01

Locations

1 site across 1 country: China