RecruitingPhase 2NCT07244406

Assessment of Senl_B19 CAR-T Cells in Relapsed/Refractory CD19+ B-ALL

A Phase II, Open-Label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Senl_B19 Autologous Anti-CD19 CAR-T Cells in Subjects With Relapsed or Refractory CD19-Positive B-Cell Acute Lymphoblastic Leukemia


Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Enrollment

59 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy and safety of S1904 in patients with relapsed or refractory CD19+B-ALL.


Eligibility

Min Age: 3 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new CAR-T cell therapy (a type of treatment where your own immune cells are engineered to fight cancer) for children and young adults with relapsed or treatment-resistant B-cell acute lymphoblastic leukemia (ALL), a type of blood cancer. **You may be eligible if...** - You are 3 to 25 years old - You have been diagnosed with B-cell ALL that has come back or stopped responding to treatment - Your cancer cells test positive for the CD19 marker - You are in reasonably good health aside from the cancer **You may NOT be eligible if...** - You have active, uncontrolled infections (including HIV, active hepatitis) - You have had prior CAR-T therapy targeting CD19 - You have significant organ dysfunction - You have untreated or active cancer in the brain or spinal fluid 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

BIOLOGICALS1904 CD19 CAR-T

Autologous CD19-targeting CAR T cells


Locations(1)

Peking University People's Hospital

Beijing, China

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NCT07244406


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