Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
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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