RecruitingPhase 1NCT06420089

CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL)

CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) to Enhance Immunotherapy Against T Cell Non-Hodgkin Lymphoma (NHL): a First-in-human Phase I Clinical Trial


Sponsor

Vittoria Biotherapeutics

Enrollment

30 participants

Start Date

Oct 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label phase I study to determine the safety and recommended phase 2 dose (RP2D) of Senza5 CART5 cells in patients with relapsed or refractory CD5 positive nodal T cell NHL. RP2D will be based on the safety, tolerability, pharmacokinetics, and preliminary efficacy of Senza5 CART5 cells. This trial will evaluate up to 5 dose levels using the Bayesian Optimal Interval (BOIN) design enrolling 3 patients in each cohort to assess safety and achieve therapeutic levels so that the RP2D of Senza5 CART5 cells given as a single IV infusion can be determined.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called Senza5 CART5 for people with certain types of T-cell lymphoma (a cancer of immune cells) that have come back or stopped responding to treatment. This approach deletes a protein (CD5) from the therapy cells so they don't accidentally attack each other. **You may be eligible if...** - You have a confirmed diagnosis of relapsed or treatment-resistant CD5-positive T-cell lymphoma - Your cancer cells show at least 50% CD5 expression - You have received at least one prior treatment - You are in reasonably good physical condition **You may NOT be eligible if...** - You have leukemic (blood-circulating) forms of T-cell cancer rather than lymphoma - Your organs are not healthy enough to tolerate the treatment - You are pregnant or breastfeeding - You have active infections that are not under control 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

DRUGSenza5 CART5

The Senza5 CART5 drug product consists of a dual population of engineered autologous T cells: CD5 knockout (KO)cells and CD5KO-CART5 cells


Locations(2)

Columbia University Irving Medical Center

New York, New York, United States

University of Pennsylvania - Abramson Caner Center

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06420089


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