Assessment of Senl_B19 CAR-T Cells in Relapsed/Refractory CD19+ B-ALL

NCT07244406 | Recruiting Phase 2 DMC

• 1 other identifier: S1904-201
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of S1904 in patients with relapsed or refractory CD19+B-ALL.

Conditions

B-ALL

Outcome Measures

Primary Outcomes (1)

• Objective response rate after S1904 infusion [Effectiveness]

  Independent Review Committee (IRC)-assessed ORR (CR + CRi) at Month 3 post-infusion, as per ALL Response Criteria.

  3 months

Study Arms (1)

S1904 CD19 CAR-T

EXPERIMENTAL

Autologous CD19-targeting CAR T cells, dosage 1\*10\^6/kg, intravenous injection once

Biological: S1904 CD19 CAR-T

Interventions

S1904 CD19 CAR-T BIOLOGICAL

Autologous CD19-targeting CAR T cells

S1904 CD19 CAR-T

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

Study Officials

• Xiaojun Huang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Hongsheng Zhou

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

• Ruidong Zhang

  Beijing Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojun Huang

CONTACT

010-88325229; xjhrm@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

CN (1)