RecruitingPhase 1NCT06593145

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


Sponsor

FamiCordTx

Enrollment

6 participants

Start Date

May 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating CAR T-cell therapy — a treatment where your own immune cells are genetically reprogrammed to attack cancer — for people with hard-to-treat blood cancers that carry a marker called CD19. **You may be eligible if...** - You are between 18 and 65 years old - You have relapsed or treatment-resistant acute lymphocytic leukemia (B-ALL), large B-cell lymphoma (including DLBCL), or mantle cell lymphoma - Your cancer cells test positive for the CD19 protein - You have received at least 2 previous lines of treatment (for lymphoma) or have relapsed after a stem cell transplant (for leukemia) - Your heart, lungs, liver, kidneys are functioning well enough - Your general health score (ECOG) is 0 or 1 **You may NOT be eligible if...** - Your cancer does not express CD19 - Your organ function is below required levels - Your heart pumping function (ejection fraction) is below 50% - Your blood oxygen level is below 93% without supplemental oxygen - You weigh less than 40 kg or more than 130 kg Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFCTX-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

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NCT06593145


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