Clinical Study of UTAA07 Injection in the Treatment of Hematologic and Lymphatic Systemic Malignancies

Recruiting now · Early Phase 1

Conditions studied: Hematolymphoid Malignancies

In brief

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.

Key facts

Study ID

NCT07338604

Run by

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

People needed

15

Starts

2025-12-12

Expected to finish

2027-12-31

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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