Hematolymphoid Malignancies
Conditions
Brief 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.
Detailed description
This is a single-arm, open-label study designed to investigate the safety, tolerability, and cellular kinetic characteristics of the investigational product. Additionally, it aims to preliminarily observe the efficacy of the investigational product in subjects with relapsed/refractory hematological and lymphoid malignancies, so as to explore the optimal dose for formal clinical applications. Three dose cohorts are planned, namely 2×10⁹ CAR-γδT cells, 4×10⁹ CAR-γδT cells, and 6×10⁹ CAR-γδT cells. Additional dose cohorts may be added at the discretion of the investigator and/or collaborating institutions. The study will adopt a 3+3 dose escalation/de-escalation schema.
Interventions
CAR-T cell infusion
DRUGUTAA07 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.
Sponsors
The First Affiliated Hospital of Soochow University
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Contacts
Primary ContactYang Xu, MD
Outcome results
None listed