Senl_B19 (S1904) CD19 CAR-T for relapsed or refractory CD19+ B-ALL in children and young adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.