Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT07338604

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

Led by PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Updated on 2026-01-14

15

Participants Needed

1

Research Sites

107 weeks

Total Duration

On this page

Sponsors

P

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Lead Sponsor

T

The First Affiliated Hospital of Soochow University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older, any gender
  • Expected survival time of at least 3 months
  • ECOG performance status score of 0 or 1
  • Confirmed diagnosis of relapsed or refractory CD7-positive hematolymphoid malignancies
  • Adequate coagulation, liver, kidney, and cardiopulmonary function
  • Ability to understand the trial and provide signed informed consent
Not Eligible

You will not qualify if you...

  • History of malignant tumors other than hematolymphoid malignancies within 5 years, except carcinoma in situ
  • Positive virological or syphilis test results
  • Severe heart diseases
  • Unstable systemic diseases as judged by the investigator
  • Active or uncontrolled infections needing systemic treatment within 7 days before screening, except mild urinary, reproductive, or upper respiratory infections
  • Pregnant or breastfeeding women, or planning pregnancy within 2 years after cell infusion (for female subjects) or partners planning pregnancy within 2 years after cell infusion (for male subjects)
  • Systemic corticosteroid therapy within 7 days before screening or anticipated long-term use during the trial, excluding inhaled or topical steroids
  • Participation in other clinical studies within 1 month before screening
  • Evidence of central nervous system involvement such as tumor cells in cerebrospinal fluid or imaging suggesting CNS infiltration
  • Requirement for long-term immunosuppressant use
  • History of epilepsy or other central nervous system diseases
  • Primary immunodeficiency diseases
  • Other conditions deemed inappropriate for enrollment by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215000

Actively Recruiting

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Research Team

Y

Yang Xu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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