RecruitingPhase 1NCT05989204

TmCD19-IL18 in CD19+ Cancers

Phase I Trial of TmCD19-IL18 CAR T Cells in Patients With Relapsed or Refractory CD19+ Cancers

Sponsor

University of Pennsylvania

Enrollment

24 participants

Start Date

Nov 13, 2023

Study Type

INTERVENTIONAL

Conditions

Non-Hodgkin Lymphoma

Summary

This is a Phase I, open-label dose finding study to assess the safety and feasibility, pharmacokinetics, and preliminary efficacy of TmCD19-IL18 CAR T cells in patients with CD19+ cancers. This study will take place in two parts: a Dose-Finding Phase to determine the maximum tolerate dose (MTD), followed by a Dose Expansion Phase. In the Dose-Finding Phase, dose levels will be evaluated using a 3+3 dose escalation design to determine the MTD. Cumulative safety experience and manufacturing feasibility data from the Dose-Finding Phase will then be used to identify the dose level that can be progressed into the Dose Expansion Phase.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a type of engineered immune cell therapy (CAR T-cells) that targets CD19 — a protein found on certain blood cancer cells — in people whose lymphoma or leukemia has not responded to or has come back after standard treatments. **You may be eligible if...** - You have a CD19-positive blood cancer (such as B-cell non-Hodgkin lymphoma or leukemia) confirmed by lab testing - Your cancer has relapsed or is not responding to standard treatments - You are able to sign an informed consent **You may NOT be eligible if...** - Your cancer does not express CD19 - You have already received CD19-directed therapy recently (within 6 months) without a sufficient break - Your overall health makes you unable to tolerate cell therapy 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

BIOLOGICALTmCD19-IL18

autologous Chimeric Antigen Receptor (CAR) T cells directed against the human CD19 antigen that also express human Interleukin 18 (IL-18)

Locations(1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT05989204

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