Actively Recruiting
Assessment of Senl_B19 CAR-T Cells in Relapsed/Refractory CD19+ B-ALL
Led by Hebei Senlang Biotechnology Inc., Ltd. · Updated on 2025-11-24
59
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of S1904 in patients with relapsed or refractory CD19+B-ALL.
CONDITIONS
Official 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 comply with study requirements
- Male or female subjects aged 3 to 25 years inclusive at consent
- Confirmed diagnosis of relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) at consent
- More than 5% blasts on screening bone marrow biopsy or aspirate
- CD19-positive malignant cells by flow cytometry at screening
- For Ph+ ALL patients: relapsed/refractory status plus either failure of 2 or more TKI regimens (unless T315I mutation), TKI intolerance, 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 within 4 weeks prior to consent or systemic GVHD treatment within 4 weeks prior to infusion
- Uncontrolled active infection at time of 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, whichever is longer
- Active interstitial lung disease or pneumonitis at time of consent
- Investigator considers the participant unable to comply with the study protocol or inappropriate for the study for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
Research Team
X
Xiaojun Huang
CONTACT
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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