UTAA07 CAR-γδT cell infusion for relapsed or refractory CD7-positive blood and lymphoid cancers

Clinical Study of UTAA07 Injection in the Treatment of CD7 Positive Adult Relapsed/Refractory Hematologic and Lymphatic Systemic Malignancies

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
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07338604 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: CAR-T therapies have shown major successes in several blood cancers, but CAR-γδT cell approaches are newer with limited clinical data to date.

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.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Yang Xu, MD

Conditions Hematolymphoid Malignancies