This is a single-arm, open-label study designed to evaluate the safety, tolerability and cellular pharmacokinetic profiles of UTAA07 Injection. It also aims to preliminarily assess the efficacy of the investigational drug in subjects with relapsed/refractory hematolymphoid malignancies, so as to identify the optimal dose for subsequent formal clinical trials.
Aged ≥ 18 years, regardless of gender.
Expected survival time ≥ 3 months.
ECOG performance status score of 0-1.
Confirmed diagnosis of relapsed/refractory CD7-positive hematolymphoid malignancies at screening.
A history of malignant tumors other than hematolymphoid malignancies within 5 years prior to screening, excluding carcinoma in situ.
Positive results for virological tests or syphilis.
Severe cardiac diseases.
Unstable systemic diseases as determined by the investigator.
Single group
CAR-T cell infusion
DrugCAR-T cell infusion
UTAA07 injection
DrugUTAA07 Injection is a chimeric antigen receptor (CAR)-engineered γδ T-cell product that targets the CD7 antigen expressed on the surface of tumor cells.
Adverse Events
Types, frequencies, and severity of adverse events (AEs) and laboratory abnormalities (in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0)
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PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborator
