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CD7+ T-ALL/LBLPhase 1S101MRDNCT07280494

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

A Phase 1 study testing CAR-T Therapy in people with CD7+ T-ALL/LBL, run by Peking University People's Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 3 to 80 years
Conditions the study is for
CD7+ T-ALL/LBL
What is being tested?
CAR-T Therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
18 Aug 2025to 31 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • (1) The subject or the legal guardian understands and voluntarily signs the informed consent form (ICF).
  • Male or female, age ≥ 3 years at the time of signing the informed consent form.
  • 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:
  • 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.
  • Tumor cells in the bone marrow or peripheral blood are CD7 positive as detected by flow cytometry.
  • Major organ functions must meet the following requirements:
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  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5× upper limit of normal (ULN).
  • Total bilirubin ≤ 2× ULN.
  • 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.
  • 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.
  • 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.

Who cannot join

  • Subjects with any of the following conditions will not be eligible for inclusion in this study.
  • 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.
  • Any uncontrolled active infection within 4 weeks before signing the ICF or before apheresis.
  • 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.
  • Clinically significant cardiovascular diseases, including any of the following:
  • Corrected QTc interval ≥ 480 ms (QTc interval calculated by the Fridericia formula);
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  • New York Heart Association (NYHA) class II or higher heart failure;
  • Unstable angina or acute myocardial infarction within 6 months before signing the ICF;
  • Left ventricular ejection fraction (LVEF) < 50%;
  • Uncontrolled hypertension (judged by the investigator based on the individual condition of the subject);
  • Clinically significant or requiring antiarrhythmic treatment arrhythmias (such as sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, and complete left bundle branch block, etc.).
  • Allergy to any component of the drugs to be used in this study.
  • 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.
  • 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.
  • 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:
  • Intranasal, inhaled, topical steroids or local steroid injections (such as intra-articular injections);
  • Systemic corticosteroids at a dose not exceeding 10 mg/day of prednisone or its equivalent physiological dose;
  • Steroids as prophylactic treatment for allergic reactions (such as pre-treatment before computed tomography [CT]);
  • For the treatment of adverse reactions after reinfusion.
  • Received major surgery within 4 weeks before signing the ICF (routine biopsy surgeries excluded), or expected to undergo major surgery during the study period.
  • 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).
  • Received live attenuated vaccines within 4 weeks before signing the ICF or planned to receive live attenuated vaccines during the screening period.
  • 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.
  • Pregnant or lactating.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jing Liu contact

8610-88326900

greenimp@163.com

Na Kuang contact

86-18630160116

kuangna@senlangbio.com

China1 site, 1 recruiting

  • Peking University People's Hospital

    Beijing, China, 100044

    liujing0245@bjmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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

Read the 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.

Conditions
CD7+ T-ALL/LBL
Being tested
CAR-T Therapy
Keywords
CD7, CAR T cell therapy, T-lymphoblastic leukemia/lymphoma, measurable residual disease, allogeneic hematopoietic stem cell transplantation
Medical subject headings
Lymphoma, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAR-T TherapyDrug

    autologous or donor-derived CD7-targeted CAR-T cells, single injection

Study groups in NCT07280494
Study groupRoleWhat they receive
anti CD7 CAR-T cells therapyExperimentaleligible patients will be treated with CD7-targeted CAR-T cells
Receives: Drug: CAR-T Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. +1m MRD negtaive rate

    The MRD negative rate post CAR-T infusion

    Measured: 28 days post CAR-T infusion

Secondary outcomes (6)

  1. +2m MRD negative rate

    The MRD negative rate at 2 months post CAR-T infusion

    Measured: at 2 months post CAR-T infusion

  2. +3m MRD negative rate

    The MRD negative rate at 3 months post CAR-T infusion

    Measured: at 3 months post CAR-T infusion

  3. survival

    overall survival and progress free survival,non-relapse survival

    Measured: at 1 year post CAR-T infusion

  4. relapse

    the cumulative incidence of leukemia relapse

    Measured: at 1 year post CAR-T infusion

  5. GVHD

    The incidence of grade III-IV acute GVHD and moderate to severe chronic GVHD.

    Measured: 1 year post CAR-T infusion

  6. hematological toxicity

    the incidenc and duration of Grade III-IV hematological toxicity

    Measured: 3 months post CAR-T therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start18 Aug 2025
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A single group of patients receives a dose of 2e6 cells/kg NS CD7-targeted cell therapy.
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07280494
Sponsor's protocol ID
Anti CD7 CAR-T for MRD+ T-ALL
Acronym
S101MRD
Status last verified
Dec 2025
First submitted
1 Dec 2025
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAR-T Therapy in people with CD7+ T-ALL/LBL, run by Peking University People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jing Liu (8610-88326900, greenimp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

+1m MRD negtaive rate (time frame: 28 days post CAR-T infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07280494.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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