RecruitingPhase 1Phase 2NCT06834529

CAR2219 CAR-T Cells for the Treatment of R/R B Cell Leukemia and Lymphoma

Safety and Efficacy of CAR2219 CAR-T Cells in Treatment of Relapsed/refractory CD19/CD22 Positive B Cell Leukemia and Lymphoma


Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Enrollment

20 participants

Start Date

Jan 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm study to evaluate the safety and efficacy of CAR2219 CAR-T cells in the treatment of relapsed/refractory CD19/CD22 positive B cell Leukemia and Lymphoma.


Eligibility

Min Age: 14 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests CAR2219, a next-generation CAR T-cell therapy that targets two proteins on leukemia and lymphoma cells (CD19 and CD22) at once, to reduce the chance that cancer cells escape by losing one target. It is designed for patients whose B-cell blood cancers have relapsed or are no longer responding to other treatments. **You may be eligible if...** - You are willing to give informed consent - You have B-cell leukemia or lymphoma (such as B-ALL, CLL, DLBCL, follicular lymphoma, or others) that is relapsed or refractory (come back or stopped responding) - Your cancer cells test positive for CD19 and/or CD22 - You have relapsed within 12 months after first remission, or never achieved remission, or relapsed after prior treatments **You may NOT be eligible if...** - Your cancer has spread to the brain or spinal fluid without treatment - You have severe organ dysfunction - You are pregnant - You have an active, serious infection 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

GENETICCAR2219-T cells

Genetic: CAR2219-T cells Each subject will be infused with single dose of CD2219-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 5×10\^5 /kg, the medium dose is 1×10\^6 /kg, and the high dose is 2×10\^6 /kg. Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD2219-CAR-T cells. Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD2219-CAR-T cells.


Locations(1)

the Fifth Medical Center of Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT06834529


Related Trials