NCT06593145

CAR T Cells in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms

Application of the Autologous CAR T Cells (Tarcidomgen Kimleucel) in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: FamiCordTx · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

One arm, open label study to assess the clinical use of Investigational Medicinal Product FCTX-CL19-1 (scientific name: Tarcidomgen Kimleucel) containing autologous anti-CD19 CAR T cells with a preliminary determination of the safety of intravenous IMP administration in patients diagnosed with refractory and relapsed CD19 + B cell neoplasms.

Detailed description

The aim of the study is to determine the safety of therapy with the study medicinal product FCTX-CL19-1 (Tarcidomgen Kimleucel) with preliminary determination of efficacy, as part of a phase I clinical trial in patients with relapsed and refractory B-cell CD19+ tumors. The hypothesis of the study assumes that the use of the newly developed product FCTX-CL19-1 (Tarcidomgen Kimleucel) containing autologous anti-CD19 CAR T cells is safe and will lead to remission of B-cell cancer resistant to current treatment.

Conditions

• Acute Lymphoblastic Leukemia (ALL)
• Mantle Cell Lymphoma (MCL)
• Large B-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	FCTX-CL19-1 (Tarcidomgen Kimleucel)	It will be administered only by Investigators during hospitalization. Each patient will receive one administration of IMP on Day 0: * administration route - intravenous * cell dose: 0,2 x 106 -2 x 106 CAR T cells per kilogram of patient body weight

Timeline

• Start date: 2023-05-24
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

2 sites across 1 country: Poland