CD7-targeted CAR-T therapy for relapsed or refractory peripheral T-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1, single-center study will deliver CD7-directed CAR-T cells to adults with relapsed or refractory CD7-positive peripheral T-cell lymphoma using a 3+3 dose-escalation design to determine safety and the recommended phase 2 dose. Eligible participants must have histologically confirmed CD7-positive disease, at least one measurable lesion, and adequate organ function before enrollment. Patients will be closely monitored for adverse events, blood counts, and tumor response by CT/PET at each dose level, and investigators will record response rates and duration of response. The trial is conducted at Peking University People's Hospital in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years old and\<80 years old；
2. 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；
3. Relapse or refractory peripheral T-cell lymphoma, which has not achieved remission or relapsed after receiving ≥ 1 line of systemic treatment in the past；
4. Histologically confirmed as CD7 positive；
5. According to Lugano2014 standard, enhanced CT before enrollment should indicate at least one evaluable tumor lesion, and PET/CT should show metabolic activity.
6. 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；
7. 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;
8. left ventricular Ejection fraction (LVEF) ≥ 50%.
9. Estimated survival time of over 3 months.
10. ECOG: 0-1.
11. Subjects or their Legal guardian voluntarily participate in the trial and sign the informed consent form.

Exclusion Criteria:

1. Primary cutaneous T-cell lymphoma, including mycosis fungoides (MF) and Sezary syndrome (SS); T-lymphoblastic leukemia/lymphoma（T-ALL/LBL）；
2. Primary central nervous system cell lymphoma, or with active central nervous system invasion；
3. If anti-tumor treatment has been received before infusion, and drugs have not been completely eliminated must be excluded;
4. Individuals with a history of allergies to any component in cellular products.
5. 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.
6. Previous history of craniocerebral trauma, Disorders of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.
7. Uncontrolled severe active infections.
8. The subject has a history of other primary cancers, except for the following.
9. Subjects with autoimmune diseases requiring treatment or subjects requiring Immunosuppressive drug treatment.
10. Individuals with graft versus host disease (GvHD) and/or requiring immunosuppressive therapy.
11. Live vaccination within 4 weeks prior to screening.
12. The subject has a history of alcoholism, drug abuse, or mental illness.
13. Individuals with EBV DNA copy numbers greater than the upper limit of normal or positive for EBER; CMV copies greater than the upper limit of normal values; HBV or HCV DNA copy number\>the upper limit of normal value, and active syphilis or AIDS and other virus infected persons.
14. Subjects who were receiving systemic hormone treatment before screening and who were judged by the investigator to need long-term use of systemic hormone during treatment (except for inhalation or local use).
15. Individuals who have participated in other clinical trials within the first 4 weeks of screening.
16. Pregnant and lactating women and subjects with Fertility who cannot take effective contraceptive measures (both men and women).
17. Any situation that the researcher believes may increase the risk of the subject or interfere with the test results.

Where it's running

• Peking University People's Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Xiaodong Mo, phd
• Email: mxd453@163.com
• Phone: 8610-88326002

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.