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

NCT ID: NCT07244406

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2028-12-31

Brief Summary

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

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.

Conditions

B-ALL

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S1904 CD19 CAR-T

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

Group Type: EXPERIMENTAL

S1904 CD19 CAR-T

Intervention Type: BIOLOGICAL

Autologous CD19-targeting CAR T cells

Interventions

S1904 CD19 CAR-T

Autologous CD19-targeting CAR T cells

Intervention Type: BIOLOGICAL

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;

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Senlang Biotechnology Inc., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaojun Huang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Hongsheng Zhou

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Ruidong Zhang

Role: PRINCIPAL_INVESTIGATOR

Beijing Children's Hospital

Locations

Peking University People's Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaojun Huang

Role: CONTACT

xjhrm@medmail.com.cn

010-88325229

Facility Contacts

Xiaojun Huang

Role: primary

Other Identifiers

S1904-201

Identifier Type: -

Identifier Source: org_study_id