About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CAR-T cell infusion
- UTAA07 injection
Treatment groups
Sponsors and collaborators
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborator