NCT07244406 Assessment of Senl_B19 CAR-T Cells in Relapsed/Refractory CD19+ B-ALL
| NCT ID | NCT07244406 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hebei Senlang Biotechnology Inc., Ltd. |
| Condition | B-ALL |
| Study Type | INTERVENTIONAL |
| Enrollment | 59 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 59 participants in total. It began in 2025-01-10 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the efficacy and safety of S1904 in patients with relapsed or refractory CD19+B-ALL.
Eligibility 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;
Contact & Investigator
Xiaojun Huang
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT07244406 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 25 Years, studying B-ALL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07244406 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07244406 currently recruiting?
Yes, NCT07244406 is actively recruiting participants. Contact the research team at xjhrm@medmail.com.cn for enrollment information.
Where is the NCT07244406 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07244406 clinical trial?
NCT07244406 is sponsored by Hebei Senlang Biotechnology Inc., Ltd.. The principal investigator is Xiaojun Huang at Peking University People's Hospital. The trial plans to enroll 59 participants.