Clinical trial · Interventional
Clinical Study of UTAA07 Injection in the Treatment of Hematologic and Lymphatic Systemic Malignancies
Clinical Study of UTAA07 Injection in the Treatment of CD7 Positive Adult Relapsed/Refractory Hematologic and Lymphatic Systemic Malignancies
NCT07338604CI-TRIAL-00100874recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematolymphoid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T cell infusion | Drug | — | UNRESOLVED |
| UTAA07 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- UTAA07 injection
- interventionNames
- Drug: CAR-T cell infusion
- Drug: UTAA07 injection
Primary outcomes (1)
- measure
- Adverse Events
- timeFrame
- 24 months
- description
- Types, frequencies, and severity of adverse events (AEs) and laboratory abnormalities (in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDYou MJ, Medeiros LJ, Hsi ED. T-lymphoblastic leukemia/lymphoma. Am J Clin Pathol. 2015 Sep;144(3):411-22. doi: 10.1309/AJCPMF03LVSBLHPJ. PMID 26276771