RecruitingPhase 2NCT06608732

Combination of Inaticabtagene Autoleucel With Autologous Hematopoietic Stem Cell Transplantation for Adolescents or Adults With MRD-Positive B-Cell Acute Lymphoblastic Leukemia in Initial Complete Remission.

Clinical Study of Inaticabtagene Autoleucel Combined With Autologous Hematopoietic Stem Cell Transplantation for Adolescents or Adults With MRD-Positive B-Cell Acute Lymphoblastic Leukemia in Initial Complete Remission.


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

20 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluate the safety and efficacy of Inaticabtagene autoleucel combined with autologous hematopoietic stem cell transplantation in adolescents or adults with MRD-positive initial complete remission in B-cell acute lymphoblastic leukemia.


Eligibility

Min Age: 16 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy called inaticabtagene autoleucel combined with a stem cell transplant for adolescents and adults with B-cell acute lymphoblastic leukemia (a blood cancer) who are in remission but still have detectable cancer cells (called MRD-positive, or minimal residual disease). The goal is to eliminate those remaining cancer cells and prevent relapse. **You may be eligible if...** - You are newly diagnosed with B-cell ALL and achieved remission after initial chemotherapy - You still have detectable cancer cells (MRD positive) in your bone marrow after consolidation therapy - You are physically well enough for a stem cell transplant - Your organs are functioning adequately **You may NOT be eligible if...** - You have Burkitt lymphoma/leukemia or certain other subtypes of leukemia - You have significant organ dysfunction - You are not a candidate for autologous stem cell transplantation 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

BIOLOGICALInaticabtagene autoleucel

CNCT19 combined with autologous hematopoietic stem cell transplantation,Dose: (0.5 -2)x 10\^6/kg CNCT19 Cell Injection via intravenous infusion.


Locations(1)

National Institute of Hematology, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

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NCT06608732


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