RecruitingPhase 2NCT06179524

CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/Refractory B-ALL

Phase II Clinical Study of CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/refractory B-cell Acute Lymphoblastic Leukemia(B-ALL) Under 25 Years of Age (inclusive)


Sponsor

Beijing Yongtai Ruike Biotechnology Company Ltd

Enrollment

100 participants

Start Date

Jan 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase II clinical study to evaluate the safety and efficacy of CAR-T-19 injection in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.


Eligibility

Max Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of immunotherapy called CAR-T cell therapy for children and young adults with B-cell acute lymphoblastic leukemia (B-ALL) — a blood cancer that has come back or stopped responding to treatment. CAR-T cells are made from the patient's own immune cells, reprogrammed to attack cancer cells that carry a protein called CD19. **You may be eligible if...** - You are 25 years old or younger - You have been diagnosed with B-cell leukemia (CD19-positive) that has relapsed (come back) or is not responding to current treatments - You are in reasonably good health despite your leukemia - You or a legal guardian can provide informed consent **You may NOT be eligible if...** - Your leukemia cells do not have the CD19 marker - You have active, uncontrolled infections (including active HIV or hepatitis) - You have severe organ problems (heart, liver, kidney, or lung) - You are pregnant or breastfeeding 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

BIOLOGICALCAR-T-19 cell injection

The functional component of CAR-T-19 cell injection is T cells that have been genetically modified to express anti CD19 chimeric antigen receptors.


Locations(1)

Hematology Hospital of the Chinese Academy of Medical Sciences

Tianjin, China

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NCT06179524