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

Launched by BEIJING GOBROAD HOSPITAL · Apr 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CD7 CAR T-cell therapy for patients with certain types of T-cell lymphomas that have not responded to standard treatments. T-cell lymphomas are a kind of cancer that affects the lymphatic system, and this trial aims to assess how safe this new therapy is for patients who have run out of other treatment options. The trial will enroll about 36 participants aged 14 to 70 who have been diagnosed with CD7-positive T-cell lymphomas that have not improved with prior chemotherapy and have a poor prognosis.

Participants in the trial will receive the CD7 CAR T-cell therapy and will be monitored closely for any side effects during the first 21 days after treatment. To qualify for the study, patients must be in relatively good health, meaning they should have a life expectancy of at least 60 days and be able to understand and sign a consent form. However, certain health conditions, such as severe heart or lung problems, infections, or other serious illnesses, may prevent someone from joining the trial. This study is currently recruiting, and it's an opportunity for patients with limited treatment options to explore a potentially promising new therapy.

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.