RecruitingPhase 1

To Observe the CD7-targeted CAR-T Therapy in the Treatment of r/r PTCL

China18 participantsStarted 2025-08-18

Plain-language summary

To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed PTCL.

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 years old and\<80 years old；
✓. According to the clinical practice guidelines for T-cell lymphoma of the National Comprehensive Cancer Network (NCCN) (2022. v2), diagnosis of peripheral T-cell lymphoma；
✓. Relapse or refractory peripheral T-cell lymphoma, which has not achieved remission or relapsed after receiving ≥ 1 line of systemic treatment in the past；
✓. Histologically confirmed as CD7 positive；
✓. According to Lugano2014 standard, enhanced CT before enrollment should indicate at least one evaluable tumor lesion, and PET/CT should show metabolic activity.
✓. Blood routine neutrophil count ≥ 1.0×109/L during screening; For individuals without bone marrow invasion, platelet count ≥ 75×109/L, Hb≥80g/L; For individuals with bone marrow invasion, platelet count ≥50×109/L, Hb≥60g/L；
✓. Creatinine clearance rate\>60ml/min (Cockcroft and Gault formula); serum total bilirubin≤1.5 times the upper limit of normal value, and serum ALT and AST ≤ 3 times the upper limit of normal value range;
✓. left ventricular Ejection fraction (LVEF) ≥ 50%.

✕. Primary cutaneous T-cell lymphoma, including mycosis fungoides (MF) and Sezary syndrome (SS); T-lymphoblastic leukemia/lymphoma（T-ALL/LBL）；
✕. Primary central nervous system cell lymphoma, or with active central nervous system invasion；
✕. If anti-tumor treatment has been received before infusion, and drugs have not been completely eliminated must be excluded;
✕. Individuals with a history of allergies to any component in cellular products.
✕. Cardiac function:cardiac dysfunction classified as Class III or IV；Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart disease clinically within 12 months of enrollment；The electrocardiogram indicates that the QT interval is significantly prolonged, and the patient has serious heart disease such as serious arrhythmia in the past.
✕. Previous history of craniocerebral trauma, Disorders of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.
✕. Uncontrolled severe active infections.
✕. The subject has a history of other primary cancers, except for the following.

safety: Dose-limiting toxicity

Timeframe: at least 28 days after the CAR-T cells infusion

NCT IDNCT07143929

SponsorPeking University People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-31

Xiaodong Mo, phd

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 years old and\<80 years old；
✓. According to the clinical practice guidelines for T-cell lymphoma of the National Comprehensive Cancer Network (NCCN) (2022. v2), diagnosis of peripheral T-cell lymphoma；
✓. Relapse or refractory peripheral T-cell lymphoma, which has not achieved remission or relapsed after receiving ≥ 1 line of systemic treatment in the past；
✓. Histologically confirmed as CD7 positive；
✓. According to Lugano2014 standard, enhanced CT before enrollment should indicate at least one evaluable tumor lesion, and PET/CT should show metabolic activity.
✓. Blood routine neutrophil count ≥ 1.0×109/L during screening; For individuals without bone marrow invasion, platelet count ≥ 75×109/L, Hb≥80g/L; For individuals with bone marrow invasion, platelet count ≥50×109/L, Hb≥60g/L；
✓. Creatinine clearance rate\>60ml/min (Cockcroft and Gault formula); serum total bilirubin≤1.5 times the upper limit of normal value, and serum ALT and AST ≤ 3 times the upper limit of normal value range;
✓. left ventricular Ejection fraction (LVEF) ≥ 50%.

✕. Primary cutaneous T-cell lymphoma, including mycosis fungoides (MF) and Sezary syndrome (SS); T-lymphoblastic leukemia/lymphoma（T-ALL/LBL）；
✕. Primary central nervous system cell lymphoma, or with active central nervous system invasion；
✕. If anti-tumor treatment has been received before infusion, and drugs have not been completely eliminated must be excluded;
✕. Individuals with a history of allergies to any component in cellular products.
✕. Cardiac function:cardiac dysfunction classified as Class III or IV；Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart disease clinically within 12 months of enrollment；The electrocardiogram indicates that the QT interval is significantly prolonged, and the patient has serious heart disease such as serious arrhythmia in the past.
✕. Previous history of craniocerebral trauma, Disorders of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.
✕. Uncontrolled severe active infections.
✕. The subject has a history of other primary cancers, except for the following.