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CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas

A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase I/II Clinical Study of Autologous and New Donor CD7 CAR-T Cells for Relapsed or Refractory Mature T-Cell Lymphomas

NCT07022964•Beijing GoBroad Hospital

View on ClinicalTrials.gov

Summary

This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD5 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD5 CAR T cell bridging to HSCT in the treatment of r/r T-NHL. The primary endpoint is the type and incidence of dose limiting toxicity (DLT) within 21 days after CD5 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.

Eligibility

Age

14 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Relapsed or refractory CD7-positive T-cell lymphomas that were treated with with standard chemotherapy, with poor prognosis from currently available treatments at and no available treatment options (e.g., HSCT or chemotherapy);
•Male or female, age 14-70;
•Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0-2;
•life expectancy is at least 60 days;
•Subjects should be capable of understanding and signing the informed consent form prior to any screening procedures. Subjects are willing to follow the study visit schedule and associated study procedures as specified in the protocol. Candidates between the ages of 19-70 years old will need to be sufficiently aware of and capable of signing the informed consent form; underage candidates between the ages of 14-18 years old will need to be sufficiently aware of the informed consent form and their legal guardian will also need to sign the informed consent form separately.

Exclusion Criteria

•Patients with history of allogeneic HSCT but PBMNC is not available from prior- transplant donor for preparation of CAR T cells and peripheral blood tumour load \>30%; patients without history of allogeneic HSCT and peripheral blood tumour load \>30%;
•Intracranial hypertension or cerebral impaired consciousness;
•Symptomatic heart failure or severe arrhythmia;
•Symptoms of severe respiratory failure;
•With other types of malignancy;
•Diffuse intravascular coagulation;
•Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value;
•With sepsis or other uncontrollable infection;
•Suffering from uncontrollable diabetes mellitus;
•Severe mental disorders;
+4 more criteria

Locations (3)

Beijing GoBroad Hospital

Beijing, China

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Shanghai Liquan Hospital

Shanghai, China

Key Dates

Start Date

June 1, 2025

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2028

Last Updated

June 15, 2025

Enrollment

ESTIMATED participants

Conditions

T-Cell Non-Hodgkin LymphomaT-cell Lymphoma (PTCL and CTCL)

Interventions

CD5 CAR-T cells infusion

DRUG

Contacts

Haiyang LU, Ph.D

CONTACT

86+ 18221015770 lhy13062@rjh.com.cn

Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma

NCT07356245

T-cell LymphomaGraft Versus Host Disease+6 more

View study

RECRUITINGPHASE1/PHASE2

CD7 CAR T-Cell Therapy for r/r T-cell Lymphomas

NCT06925464

T-Cell Non-Hodgkin LymphomaT-cell Lymphoma (PTCL and CTCL)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas

Inclusion Criteria

Exclusion Criteria

Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma

CD7 CAR T-Cell Therapy for r/r T-cell Lymphomas

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