Clinical Trials in China / NCT07244406
Recruiting
Phase 2
Assessment of Senl_B19 CAR-T Cells in Relapsed/Refractory CD19+ B-ALL
NCT07244406 · tracked via the Priya Life Science China tracker
Condition(s) studied
B-ALL
Investigational drug(s) / intervention(s)
S1904 CD19 CAR-T
S1904 CD19 CAR-T: Autologous CD19-targeting CAR T cells
Study summary
To evaluate the efficacy and safety of S1904 in patients with relapsed or refractory CD19+B-ALL.
Eligibility
Inclusion Criteria:
* 1.Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart; 2.Male or female subjects. Age between 3 and 25 years (inclusive) at the time of ICF signing; 3.Confirmed diagnosis of relapsed/refractory B-ALL at ICF signing; 4.\>5% blasts on screening bone marrow biopsy/aspirate; 5.CD19+ malignant cells by flow cytometry (bone marrow or peripheral blood) at screening; 6.Patients with Ph+ ALL are eligible if they meet the relapsed/refractory criteria and have either: failed ≥2 TKI regimens (unless they have a T315I mutation), demonstrated TKI intolerance, or have a contraindication to TKIs; 7.Estimated survival time\>3 months.
Exclusion Criteria:
* 1.Relapse of isolated extramedullary disease; 2.Burkitt lymphoma/leukemia; 3.Active acute or moderate-to-severe chronic GVHD within 4 weeks prior to ICF signing. Or, any systemic GVHD treatment within 4 weeks prior to infusion; 4.No uncontrolled active infection at the time of ICF signing or apheresis.; 5.Prior receipt of any CAR-T therapy or other cellular/gene therapy before screening; 6.Received investigational drugs or systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever longer) prior to apheresis; 7.Active interstitial lung disease/pneumonitis at the time of ICF signing; 8.Subjects whom the Investigator considers unable to comply with the study protocol or who are otherwise not an appropriate candidate for the study for any reason;
Primary outcome measure(s)
- Objective response rate after S1904 infusion [Effectiveness] — 3 months
Independent Review Committee (IRC)-assessed ORR (CR + CRi) at Month 3 post-infusion, as per ALL Response Criteria.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University People's Hospital | Beijing | China | Recruiting |
More Hebei Senlang Biotechnology Inc., Ltd. trials in China
Other trials for the same condition
The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors
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JY231(JY231) Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma/ Leukemia
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07244406 on ClinicalTrials.gov ↗ ← All trials in China