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

November 17, 2025 updated by: Hebei Senlang Biotechnology Inc., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective： To evaluate the efficacy of S1904 in pediatric and adult subjects with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia.

The secondary objectives： To further characterize the efficacy and safety profiles of S1904 in this patient population.

Study Type

Interventional

Enrollment (Estimated)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Xiaojun Huang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S1904 CD19 CAR-T
Autologous CD19-targeting CAR T cells, dosage 1*10^6/kg, intravenous injection once
Biological: S1904 CD19 CAR-T
Autologous CD19-targeting CAR T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate after S1904 infusion [Effectiveness]
Time Frame: 3 months
Independent Review Committee (IRC)-assessed ORR (CR + CRi) at Month 3 post-infusion, as per ALL Response Criteria.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Investigators

  • Principal Investigator: Xiaojun Huang, Peking University People's Hospital
  • Principal Investigator: Hongsheng Zhou, Nanfang Hospital, Southern Medical University
  • Principal Investigator: Ruidong Zhang, Beijing Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • S1904-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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