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

Launched by BEIJING GOBROAD HOSPITAL · Jun 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CD5 CAR T-cell therapy for patients with certain types of T-cell lymphomas that have either come back or did not respond to previous treatments. The goal of the trial is to evaluate how safe this new therapy is and to understand any potential side effects that might occur within 21 days after the treatment. The researchers are looking to enroll about 36 participants who are between the ages of 14 and 70, have CD7-positive T-cell lymphomas, and have not found success with standard chemotherapy options.

Eligible participants must be in relatively good health and able to understand the study's requirements, including signing an informed consent form. They should have a life expectancy of at least 60 days and be willing to follow the study schedule. However, certain conditions, like severe heart or respiratory issues, active infections, or other serious health problems, may prevent someone from joining the study. If you or a loved one is interested, this trial could offer a new treatment option for challenging lymphomas, but it's important to discuss all potential risks and benefits with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (Patients who met all the inclusion criteria were eligible for enrolment):
• • 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 who fulfil any of the following criteria may not be enrolled):
• • 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;
• • Have significant intracranial lesions on cranial MRI;
• • Organ transplantation (excluding haematopoietic stem cell transplantation) history;
• • Female patients (patients of childbearing potential) with positive blood HCG test;
• • Hepatitis (including hepatitis B and C) and positive screening for AIDS and syphilis.