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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPersonGen BioTherapeutics (Suzhou) Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CAR-T cell infusion
  • UTAA07 injection

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Lead sponsor

The First Affiliated Hospital of Soochow University

Collaborator