Phase II Trial of S101 Autologous Anti-CD7 CAR-T Cells in Patients With R/R T-LBL/ALL.

NCT07244380 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CARMA-II
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

To Evaluate the Efficacy and safety of S101 for Treating CD7-Positive Relapsed or Refractory T-LBL/ALL.

Conditions

T Lymphoblastic Leukemia/Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate after S101 infusion [Effectiveness]

  Independent Review Committee (IRC)-assessed ORR at Month 3 post-infusion.

  3 months

Study Arms (1)

S101 CD7 CAR-T

EXPERIMENTAL

Autologous CD7-targeting CAR T cells, dosage 2\*10\^6/kg, intravenous injection once

Biological: Autologous CD7-targeting CAR T cells

Interventions

Autologous CD7-targeting CAR T cells BIOLOGICAL

Autologous CD7-targeting CAR T cells, dosage 2\*10\^6/kg, intravenous injection once

S101 CD7 CAR-T

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject or guardian must provide voluntary informed consent; 2.Heavily pretreated patients with relapsed or refractory T-LBL/ALL who lack effective therapeutic alternatives; 3.At screening, CD7 positivity of tumor cells must be documented by flow cytometry (on bone marrow or peripheral blood samples) and/or by immunohistochemistry (IHC) confirming CD7 expression on an extramedullary lesion biopsy; 4.If malignant cells are detected in the peripheral blood at screening, they must demonstrate a CD4-negative and CD8-negative (double-negative) immunophenotype as assessed by flow cytometry; 5.Male or female subjects, aged 18 to 75 years (inclusive); 6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2; 7.Estimated survival time\>12 weeks.

You may not qualify if:

• Patients with a history of allogeneic hematopoietic stem cell transplantation within the past 6 months are excluded; 2.Active or uncontrolled infection requiring systemic treatment at screening, excluding mild genitourinary and upper respiratory infections； 3.Participation in another clinical trial within 4 weeks prior to signing the informed consent form (ICF), OR the date of ICF signing occurring within 5 half-lives of the last dose from a previous investigational drug trial (whichever timeframe is longer); 4.Patients with previous treatment involving CAR-T cells or other gene-modified cell therapies are excluded; 5.Patients with acute GVHD (aGVHD) or moderate-to-severe chronic GVHD (cGVHD) within 4 weeks prior to screening, or those who have received systemic pharmacologic therapy for GVHD within 4 weeks prior to infusion; 6.Patients who have received extensive radiotherapy within 4 weeks prior to ICF signing, with the exception of non-target lesion radiotherapy administered for symptomatic palliation that may be permitted during the study period; 7.Women who are pregnant or lactating; 8.Any condition that, in the judgment of the Investigator, could increase the subject's risk or compromise the interpretation of the trial results.

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Xiangyu Zhao

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

• Weili Zhao

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangyu Zhao

CONTACT

01088325229; Zhao_xy@bjmu.edu.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: November 28, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11