RecruitingPhase 1NCT06879340

Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies

A Phase 1 Multicenter, Open Label Trial Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies


Sponsor

University of Kansas Medical Center

Enrollment

54 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This multicenter phase 1 trial with "3 + 3" dose escalation design seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of chimeric antigen receptors targeting the B cell surface antigens CD19/20/22 following administration of a chemotherapy lymphodepletion regimen in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) or Non-Hodgkin's lymphoma (NHL). The overall goals of this study are to estimate maximum tolerated dose (MTD) level, establish the overall safety profile and evaluate initial efficacy of administering duo-CAR-T cell treatment in this patient population.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests DuoCAR20.19.22-D95, an experimental CAR-T cell therapy that targets three proteins (CD20, CD19, and CD22) found on certain B-cell blood cancers. CAR-T therapy involves modifying a patient's own immune cells in a lab to attack cancer cells. This trial is for patients whose B-cell cancer has returned or stopped responding to previous treatments. **You may be eligible if:** - You are an adult with a B-cell blood cancer (such as B-cell lymphoma or leukemia) that has relapsed or not responded to prior therapies - Your cancer has been confirmed by biopsy - You have had at least one prior treatment that did not work - You are in good enough health to tolerate the therapy - Women of childbearing potential must have a negative pregnancy test **You may NOT be eligible if:** - You are pregnant - You have active, uncontrolled infection - You have serious organ dysfunction (heart, liver, kidneys) - You have not had at least one prior line of treatment - You have a condition that makes CAR-T therapy unsafe 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDuoCAR20.19.22-D95

Patient derived autologous T cells, lentiviral transduced to generate, using the Miltenyi CliniMACS Prodigy® closed transduction system, a Duo-CAR-T cells targeting cell surface antigens CD19/20/22.

DRUGFludarabine (Conditional therapy)

Lymphodepletion chemotherapy

DRUGCyclophosphamide (Conditional therapy)

Lymphodepletion chemotherapy


Locations(1)

University of Kansas Cancer Center

Westwood, Kansas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06879340


Related Trials