To Observe the CD7-targeted CAR-T Therapy in the Treatment of MRD Positive T-ALL/LBL Post Allo-HSCT (S101MRD)

An Open-label, Clinical Study of CD7-targeted CAR-T Cells for the Treatment of Measurable Residual Disease of T-lymphoblastic Leukaemia/Lymphoma Post Allogeneic Stem Cell Transplantation

To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of T-lymphoblastic leukaemia/lymphoma with postive measurable residual disease positive post allogeneic stem cell transplantation

Study Overview

• Status: Recruiting
• Conditions: CD7+ T-ALL/LBL
• Intervention / Treatment: Drug: CAR-T Therapy

Detailed Description

This study will explore the efficacy and safety of a natural selection-targeted CD7 CART cell therapy for measurable residual disease after allogeneic hematopoietic stem cell transplantation in T-ALL/LBL. The dose of targeted CD7 CART cells is 2E6 cells/kg, with a single infusion.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Na Kuang; Phone Number: 86-18630160116; Email: kuangna@senlangbio.com
• Study Contact Backup: Name: Jing Liu; Phone Number: 8610-88326900; Email: greenimp@163.com

Study Locations

• China
  • China
    • Beijing, China, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Email: liujing0245@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (1) The subject or the legal guardian understands and voluntarily signs the informed consent form (ICF).

  (2) Male or female, age ≥ 3 years at the time of signing the informed consent form.

  (3) Expected survival period of no less than 12 weeks. (4) ECOG performance score of 0-2 at the time of signing the ICF. (5) Confirmed as relapsed/refractory T-cell leukemia or lymphoma at the time of signing the ICF, meeting the following criteria:

  1. Bone marrow morphology examination at screening shows the proportion of primitive immature lymphocytes in the bone marrow < 5%, and positive for minimal residual disease of leukemia/lymphoma determined by flow cytometry.

  2. Tumor cells in the bone marrow or peripheral blood are CD7 positive as detected by flow cytometry.

     (6) Major organ functions must meet the following requirements:

  1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5× upper limit of normal (ULN).
  2. Total bilirubin ≤ 2× ULN.
  3. For adult subjects, the serum creatinine clearance rate ≥ 60 mL/min (Cockcroft-Gault formula) or serum creatinine ≤ 1.5× ULN; for children, the serum creatinine should be no more than 0.8 mg/dL for 2 to 6 years old, 1.0 mg/dL for 6 to 10 years old, 1.2 mg/dL for 10 to 13 years old, 1.5 mg/dL for 13 to 16 years old males, and 1.4 mg/dL for females over 13 years old; for males over 16 years old, it should be no more than 1.7 mg/dL.

  4. If the above organ function abnormalities are caused by infiltration of the primary disease, the decision on whether to include the subject in the study is made by the investigator.

     (7) Blood oxygen saturation > 92%. (8) Male subjects with reproductive capacity and female subjects of childbearing age must agree to use effective contraceptive measures from the time of signing the informed consent form until 2 years after the use of the study drug. Female subjects of childbearing age include premenopausal women and women within 2 years after menopause. The blood pregnancy test of female subjects of childbearing age at screening must be negative.

     Exclusion Criteria:

• Subjects with any of the following conditions will not be eligible for inclusion in this study.

  1. A history of CNS diseases, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, and neuropathy. A history of diseases without related neurological symptoms before screening, such as lacunar infarction, etc., will be excluded at the discretion of the investigator.
  2. Any uncontrolled active infection within 4 weeks before signing the ICF or before apheresis.
  3. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening and peripheral blood hepatitis B virus (HBV) DNA above the detection limit, positive hepatitis C virus (HCV) antibody and positive HCV RNA, positive human immunodeficiency virus (HIV) antibody, cytomegalovirus (CMV) DNA above the detection limit, Epstein-Barr virus (EBV) DNA above the detection limit, and both specific and non-specific antibodies for Treponema pallidum positive need to be excluded.

  4. Clinically significant cardiovascular diseases, including any of the following:

     1. Corrected QTc interval ≥ 480 ms (QTc interval calculated by the Fridericia formula);
     2. New York Heart Association (NYHA) class II or higher heart failure;
     3. Unstable angina or acute myocardial infarction within 6 months before signing the ICF;
     4. Left ventricular ejection fraction (LVEF) < 50%;
     5. Uncontrolled hypertension (judged by the investigator based on the individual condition of the subject);
     6. Clinically significant or requiring antiarrhythmic treatment arrhythmias (such as sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, and complete left bundle branch block, etc.).
  5. Allergy to any component of the drugs to be used in this study.
  6. Received any investigational drug treatment or other systemic anti-tumor treatment within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is judged more appropriate by the investigator), except for bridging chemotherapy due to large tumor burden or rapid disease progression.
  7. Received extensive radiotherapy within 4 weeks before signing the ICF, except for local radiotherapy for symptom relief of non-target lesions during the study period.

  8. Received systemic corticosteroids (dose equivalent to or higher than 10 mg/day of prednisone) or other immunosuppressive drugs within 3 days before apheresis or during the study period, except for the following situations:

     1. Intranasal, inhaled, topical steroids or local steroid injections (such as intra-articular injections);
     2. Systemic corticosteroids at a dose not exceeding 10 mg/day of prednisone or its equivalent physiological dose;
     3. Steroids as prophylactic treatment for allergic reactions (such as pre-treatment before computed tomography [CT]);
     4. For the treatment of adverse reactions after reinfusion.
  9. Received major surgery within 4 weeks before signing the ICF (routine biopsy surgeries excluded), or expected to undergo major surgery during the study period.
  10. Had active tuberculosis infection within 1 year before signing the ICF (except for subjects with active tuberculosis infection more than 1 year ago and judged by the investigator to have no evidence of active tuberculosis at present).
  11. Received live attenuated vaccines within 4 weeks before signing the ICF or planned to receive live attenuated vaccines during the screening period.
  12. The investigator believes that the subject's complications or other conditions may affect compliance with the protocol or are not suitable for participation in this study.
  13. Pregnant or lactating.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anti CD7 CAR-T cells therapy; eligible patients will be treated with CD7-targeted CAR-T cells	Drug: CAR-T Therapy; autologous or donor-derived CD7-targeted CAR-T cells, single injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
+1m MRD negtaive rate	The MRD negative rate post CAR-T infusion	28 days post CAR-T infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
+2m MRD negative rate	The MRD negative rate at 2 months post CAR-T infusion	at 2 months post CAR-T infusion
+3m MRD negative rate	The MRD negative rate at 3 months post CAR-T infusion	at 3 months post CAR-T infusion
survival	overall survival and progress free survival,non-relapse survival	at 1 year post CAR-T infusion
relapse	the cumulative incidence of leukemia relapse	at 1 year post CAR-T infusion
GVHD	The incidence of grade III-IV acute GVHD and moderate to severe chronic GVHD.	1 year post CAR-T infusion
hematological toxicity	the incidenc and duration of Grade III-IV hematological toxicity	3 months post CAR-T therapy

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Xiaojun Huang, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: allogeneic hematopoietic stem cell transplantation; CD7; measurable residual disease; CAR T cell therapy; T-lymphoblastic leukemia/lymphoma
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Neoplastic Processes; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Neoplasm, Residual; Lymphoma; Investigative Techniques; Therapeutics; Biological Therapy; Immunologic Techniques; Immunomodulation; Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunotherapy, Adoptive
• Other Study ID Numbers: Anti CD7 CAR-T for MRD+ T-ALL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No