UTAA07 injection: UTAA07 Injection is a chimeric antigen receptor (CAR)-engineered γδ T-cell product that targets the CD7 antigen expressed on the surface of tumor cells.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
* Coagulation function, liver and kidney function, and cardiopulmonary function meeting the requirements.
* Ability to understand the trial and signed informed consent form.
Exclusion Criteria:
* 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.
* Active or uncontrolled infections requiring systemic treatment within 7 days prior to screening, excluding mild urinary and reproductive system infections and upper respiratory tract infections.
* Pregnant or lactating women; female subjects planning to become pregnant within 2 years after cell infusion; or male subjects whose partners plan to become pregnant within 2 years after the subject's cell infusion.
* Subjects receiving systemic corticosteroid therapy within 7 days prior to screening, or those judged by the investigator to require long-term systemic corticosteroid therapy during the trial period, excluding inhaled or topical administration.
* Participation in other clinical studies within 1 month prior to screening.
* Evidence of central nervous system (CNS) involvement at screening, such as detection of tumor cells in cerebrospinal fluid (CSF) or imaging findings suggestive of CNS infiltration.
* Patients requiring long-term use of immunosuppressants as determined by the investigator at screening.
* A history of epilepsy or other central nervous system diseases.
* Patients with primary immunodeficiency diseases.
* Other circumstances deemed inappropriate for enrollment by the investigator.
Primary outcome measure(s)
Adverse Events — 24 months 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)
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Soochow University
Suzhou
Jiangsu
Recruiting
More PersonGen BioTherapeutics (Suzhou) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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