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

An Open-label, Dose-escalation Early-phase Clinical Study of CD7-targeted CAR-T Cells for the Treatment of Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)

This study will try CD7-targeted CAR-T cells in adults with relapsed or refractory CD7-positive peripheral T-cell lymphoma.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: chimeric antigen receptor, CAR-T
• Locations: 1 site (Beijing)
• Trial ID: NCT07143929 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–79 with histologically confirmed CD7-positive relapsed or refractory peripheral T-cell lymphoma, measurable disease, prior systemic therapy, and adequate organ and marrow function are the intended participants.

Not a fit: Patients with CD7-negative tumors, significant organ dysfunction, active uncontrolled infections, or other exclusion criteria are unlikely to benefit from this treatment.

Why it matters

Potential benefit: If successful, this therapy could produce meaningful remissions for some patients whose PTCL has not responded to standard treatments.

How similar studies have performed: Early-phase studies of CD7-directed CAR-T therapies in T-cell leukemias and lymphomas have shown promising responses but remain experimental with unresolved safety questions.

Eligibility criteria

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 this trial is running

Beijing

• Peking University People's Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xiaodong Mo, phd

Conditions CD7 Positive R/R PTCL