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

NCT07338604 | Recruiting Early Phase 1

• 1 other identifier: PG-004-3
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematolymphoid Malignancies

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  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)

  24 months

Study Arms (1)

UTAA07 injection

EXPERIMENTAL

Drug: CAR-T cell infusion; Drug: UTAA07 injection

Interventions

CAR-T cell infusion DRUG

CAR-T cell infusion

UTAA07 injection

UTAA07 injection 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.

UTAA07 injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: collaborator
• PersonGen BioTherapeutics (Suzhou) Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

Related Publications (1)

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

  PMID: 26276771 BACKGROUND

Central Study Contacts

Yang Xu, MD

CONTACT

+86 13732628683; xuyang1020@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 14, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)