RecruitingEarly Phase 1NCT07470073

A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Cell Injection in CD19 and / or CD20 Positive Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia in Adolescents, Children and Adults


Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

18 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single arm, open label, dose exploring clinical trial to evaluate the safety, efficacy, cellular metabolic dynamics, and pharmacodynamics of ct1190b cells in relapsed / refractory B-cell acute lymphoblastic leukemia.


Eligibility

Min Age: 12 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called Universal CAR-T cells — lab-engineered immune cells designed to attack leukemia cells carrying the proteins CD19 and/or CD20 — in adolescents and adults with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), a fast-growing blood cancer that has not responded to or came back after standard treatment. **You may be eligible if...** - You are between 12 and 75 years old - You have B-ALL that has not responded to standard chemotherapy, or came back after achieving remission - Your leukemia cells test positive for CD19 and/or CD20 - At least 5% of your bone marrow or blood is made up of leukemia cells (blasts) - You have adequate kidney, liver, heart, and lung function **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active HIV, syphilis, hepatitis B, or hepatitis C - You have an active uncontrolled infection (including active tuberculosis) - You have an active autoimmune disease - You have a history of severe neurological conditions (seizures, stroke, severe brain injury) - You received a stem cell transplant within the past 12 weeks - You have received certain chemotherapy or immune therapy drugs within a specified washout window before cell infusion 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

BIOLOGICALCT1190B cell injection

The active ingredient of the drug in this study is the chimeric antigen receptor targeting cd19/cd20 (car-cd19/cd20 for short) modified allogeneic T cells. In order to reduce the rejection of GVHD and host immune cells, TCR and B2M were knocked out, and the related modifications were also carried out to reduce the host NK cell immune rejection.


Locations(1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT07470073


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