Senl_B19 (S1904) CD19 CAR-T for relapsed or refractory CD19+ B-ALL in children and young adults
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
This trial will test S1904 (Senl_B19) CD19 CAR-T cells in children and young adults aged 3–25 with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 59 (estimated) |
| Ages | 3 Years to 25 Years |
| Sex | All |
| Sponsor | Hebei Senlang Biotechnology Inc., Ltd. Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07244406 on ClinicalTrials.gov |
What this trial studies
This is a Phase 2, single-arm interventional trial of S1904 (Senl_B19) CD19-directed CAR-T cells in pediatric and young adult patients with relapsed or refractory CD19+ B-ALL. Eligible participants are 3–25 years old with confirmed relapsed/refractory disease, >5% blasts on bone marrow and CD19 expression by flow cytometry, and an estimated survival >3 months. The primary objective is to measure the efficacy (remission rates) of S1904, with secondary objectives to further characterize safety and durability of response. Treatment, monitoring for cytokine release syndrome and neurotoxicity, and follow-up occur at the trial site under sponsor oversight.
Who should consider this trial
Good fit: Ideal candidates are patients aged 3–25 with relapsed or refractory CD19-positive B-ALL, marrow blasts >5%, reasonable performance status and an expected survival beyond three months, with Ph+ patients eligible only after meeting specific TKI-failure or intolerance criteria.
Not a fit: Patients with isolated extramedullary relapse, Burkitt lymphoma/leukemia, active moderate-to-severe graft-versus-host disease, or CD19-negative disease are unlikely to benefit from this CD19-targeted therapy.
Why it matters
Potential benefit: If successful, S1904 could induce remissions and offer a new treatment option for children and young adults whose CD19+ B-ALL has returned or not responded to prior therapies.
How similar studies have performed: Other CD19-directed CAR-T therapies have produced high remission rates in relapsed/refractory B-ALL, so the overall approach is established though this specific product is new.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Beijing
- Peking University People's Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Xiaojun Huang — Peking University People's Hospital
- Study coordinator: Xiaojun Huang
- Email: xjhrm@medmail.com.cn
- Phone: 010-88325229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.