About this trial
This study is a single-arm, multicenter Investigator-Initiated Trial (IIT) clinical study. The primary objective is to evaluate the safety, pharmacokinetic characteristics, and preliminary efficacy of CAR-T cells in subjects with relapsed/refractory (r/r) CD7-positive hematological malignancies. The study plans to enroll 20 subjects, with the actual sample size to be determined based on real-world occurrence.
Eligibility criteria
Qualifiers
Patients or their guardians understand and voluntarily sign the informed consent form, and are expected to complete the follow-up examinations and treatments required by the study protocol.
Disqualifiers
History of malignancy other than T-cell hematological malignancies within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical treatment, and ductal carcinoma in situ of the breast after radical treatment.
Trial design
Treatments tested in this trial
- CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies
Treatment groups
Sponsors and collaborators
Donghua Zhang
Lead sponsor
Tongji Hospital
Sponsor institution