RecruitingPhase 1NCT05836896

A Phase I Trial to Establish the Safety and Maximum Tolerated Dose of High-affinity Autologous BCMA-targeting Chimeric Antigen Receptor (CAR) T-cells in Patients With Relapsed and Refractory B-cell Malignancies

A Phase I Trial to Establish the Safety and Maximum Tolerated Dose of High-affinity Autologous BCMA-targeting CAR T-cells in Patients With Relapsed and Refractory B-cell Malignancies


Sponsor

Technische Universität Dresden

Enrollment

16 participants

Start Date

Feb 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this phase I study is to determine whether MDC-CAR-BCMA001 (BCMA directed CAR T-cells) is safe and tolerable in the treatment of relapsed and refractory B-cell malignancies


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase I study is testing a new type of CAR T-cell therapy — immune cells from the patient's own blood that are engineered to target a protein called BCMA on cancer cells — in patients with advanced multiple myeloma or diffuse large B-cell lymphoma (DLBCL) that has relapsed or stopped responding to multiple prior treatments. The study is primarily focused on establishing safety and the right dose. **You may be eligible if...** - You are 18 or older with either multiple myeloma or aggressive B-cell lymphoma that has relapsed or stopped responding to treatment - For myeloma: you have received at least 2 prior lines of therapy including specific drug classes - For lymphoma: your cancer has relapsed or failed standard salvage chemotherapy, autologous transplant, or other approved therapies - Your general health allows participation (ECOG score 0–2) - Your organ function meets minimum requirements **You may NOT be eligible if...** - You have active uncontrolled infections - You have severe heart, lung, or liver problems - Your cancer has spread to the brain - You have other serious medical conditions that make the treatment too risky 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

GENETICMDC-CAR-BCMA001 (BCMA directed CAR T-cells)

Single-dose intravenous infusion of MDC-CAR-BCMA001 at the respective dose level following a conditioning chemotherapy


Locations(1)

Technische Universität Dresden, NCT/UCC, Early Clinical Trial Unit

Dresden, Germany

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NCT05836896


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