Actively Recruiting
A Phase II Clinical Study Evaluating Senl_B19 Autologous Anti-CD19 CAR-T Cells for Relapsed or Refractory CD19-Positive B-Cell Acute Lymphoblastic Leukemia
Led by Hebei Senlang Biotechnology Inc., Ltd. · Updated on 2025-11-24
59
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of S1904, an autologous anti-CD19 CAR-T cell therapy, in children and young adults aged 3 to 25 years with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL). This Phase II, open-label, multicenter study aims to assess the treatment effects and further characterize safety in this patient group. Participants will receive a single intravenous infusion of S1904 CAR-T cells at a dose of 1 million cells per kilogram of body weight. The treatment involves using the patient's own modified immune cells to target CD19-positive leukemia cells. There are no placebo or comparator groups, and the study is designed to monitor the response to this experimental therapy. During the study, participants will undergo evaluations including bone marrow biopsies and flow cytometry to confirm disease status and CD19 expression. Researchers will measure the objective response rate three months after infusion to assess effectiveness. Safety and treatment tolerability will also be closely monitored throughout the trial, which is expected to continue until the end of 2028.
CONDITIONS
Brief Title
Assessment of Senl_B19 CAR-T Cells in Relapsed/Refractory CD19+ B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willingness to follow all study visits and procedures
- Male or female aged between 3 and 25 years at consent
- Confirmed diagnosis of relapsed or refractory CD19-positive B-ALL
- More than 5% blasts in bone marrow biopsy or aspirate at screening
- Presence of CD19-positive malignant cells by flow cytometry
- For Ph+ ALL patients, must have relapsed/refractory disease with failed or intolerance to at least two TKI treatments or contraindication to TKIs
- Estimated survival time greater than 3 months
You will not qualify if you...
- Relapse limited to isolated extramedullary disease
- Diagnosis of Burkitt lymphoma or leukemia
- Active acute or moderate-to-severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to consent or systemic GVHD treatment within 4 weeks before infusion
- Uncontrolled active infection at consent or apheresis
- Prior receipt of any CAR-T or other cellular/gene therapy before screening
- Receipt of investigational drugs or systemic anti-tumor therapy within 4 weeks or 5 half-lives before apheresis
- Active interstitial lung disease or pneumonitis at consent
- Investigator judgment deeming participant unable to comply or unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until disease progression or discontinuation
Participants receive a single intravenous infusion of autologous CD19-targeting CAR T cells (S1904).
1 infusion visit and follow-up visits over 3 months
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
Research Team
X
Xiaojun Huang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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