UTAA07 CAR-γδT cell infusion for relapsed or refractory CD7-positive blood and lymphoid cancers
Official title: Clinical Study of UTAA07 Injection in the Treatment of CD7 Positive Adult Relapsed/Refractory Hematologic and Lymphatic Systemic Malignancies
Run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. · NCT07338604 · Data updated 2026-11-12
This study will try UTAA07 CAR-γδT cell infusions in adults with relapsed or refractory CD7-positive hematologic and lymphoid cancers to see if they are safe and help control the disease.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | PersonGen BioTherapeutics (Suzhou) Co., Ltd. Industry-sponsored |
| Locations | 1 site (Suzhou, Jiangsu) |
| Status | Recruiting |
| Started | December 12, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | January 14, 2026 |
| Trial ID | NCT07338604 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with relapsed or refractory CD7-positive hematolymphoid malignancies, ECOG 0–1, expected survival ≥3 months, and adequate organ and coagulation function who can give informed consent.
✕Probably not a fit
Patients unlikely to benefit include those with CD7-negative disease, recent other active malignancies, uncontrolled infections, severe cardiac disease, positive viral tests, pregnant or breastfeeding women, or those who do not meet organ-function requirements.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-arm, open-label early phase 1 trial enrolls adults with relapsed or refractory CD7-positive hematolymphoid malignancies to receive escalating doses of UTAA07, a CAR-γδT cell product. Three planned dose cohorts (2×10^9, 4×10^9, and 6×10^9 CAR-γδT cells) follow a 3+3 dose escalation/de-escalation schema, with additional cohorts possible at investigator discretion. The study focuses on safety, tolerability, and cellular pharmacokinetics, while also collecting preliminary anti-tumor activity to inform an optimal dose for later trials. All treatment and follow-up are conducted at The First Affiliated Hospital of Soochow University under an open-label protocol.
Why it matters
Potential benefit: If successful, the therapy could provide a new targeted cellular treatment option that controls disease in patients with relapsed or refractory CD7-positive hematolymphoid malignancies.
How similar studies have gone: CAR-T therapies have shown major successes in several blood cancers, but CAR-γδT cell approaches are newer with limited clinical data to date.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Yang Xu, MD
- Email: xuyang1020@126.com
- Phone: +86 13732628683
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.