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

NCT06593145 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • FamiCordTx

    lead INDUSTRY

Principal Investigators

  • Emilian Snarski · FamiCordTx S.A.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-24
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06593145 on ClinicalTrials.gov