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

NCT ID: NCT07338604

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-12
• Study Completion Date: 2027-12-31

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.

Conditions

Hematolymphoid Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UTAA07 injection

Group Type: EXPERIMENTAL

CAR-T cell infusion

Intervention Type: DRUG

CAR-T cell infusion

UTAA07 injection

Intervention Type: DRUG

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.

Interventions

CAR-T cell infusion

CAR-T cell infusion

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Xu, MD

Role: CONTACT

xuyang1020@126.com

+86 13732628683

Facility Contacts

Yang Xu, MD

Role: primary

xuyang1020@126.com

+86 13732628683

References

You MJ, Medeiros LJ, Hsi ED. T-lymphoblastic leukemia/lymphoma. Am J Clin Pathol. 2015 Sep;144(3):411-22. doi: 10.1309/AJCPMF03LVSBLHPJ.

Reference Type: BACKGROUND

PMID: 26276771 (View on PubMed)

Other Identifiers

PG-004-3

Identifier Type: -

Identifier Source: org_study_id