NCT07244406RecruitingPhase 2
Assessment of Senl_B19 CAR-T Cells in Relapsed/Refractory CD19+ B-ALL
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
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
To evaluate the efficacy and safety of S1904 in patients with relapsed or refractory CD19+B-ALL.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 10 Jan 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- NCT number
- NCT07244406
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 59
- From 10 Jan 2025 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Who the study is looking for
- 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.
Age in the registry: 3 years to 25 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.