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RECRUITING
NCT06593145
PHASE1

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

Sponsor: FamiCordTx

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2023-05-24

Completion Date

2025-06

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

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

Locations (2)

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego - Centralny Szpital Kliniczny

Warsaw, Ul. Banacha 1a, Poland

Uniwersyteckie Centrum Kliniczne Gdańskiego Uniwersytetu Medycznego - Katedra i Klinika Hematologii i Transplantologii

Gdansk, Ul. Smoluchowskiego 17, Poland