Clinical trial · Interventional
Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute
NCT05722171CI-TRIAL-00063826unknownEarly 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, dose-escalation study to explore the safety, efficacy, and cytodynamic characteristics of the drug, and to initially observe the efficacy of the drug in subjects with relapsed/refractory B7-H3-positive acute myeloid cell line leukemia.
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 |
|---|---|---|---|
| Relapsed/Refractory Acute Myeloid Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gdT cell injection targeting B7-H3 chimeric antigen receptor | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- gdT cell injection targeting B7-H3 chimeric atigen receptor
- description
- UTAA06 injection
- interventionNames
- Biological: gdT cell injection targeting B7-H3 chimeric antigen receptor
Primary outcomes (1)
- measure
- Assessment of the safety after UTAA06 injection treatment (Safety)
- timeFrame
- About 2 years
- description
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Secondary outcomes (3)
- measure
- To evaluate anti-tumor activity (overall survival)
- timeFrame
- About 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * (1) Age≥ 18 years old, gender is not limited; * (2) expected survival time≥ 3 months; * (3) ECOG score 0-1 points; * (4) Acute myeloid leukemia was clearly diagnosed during screening, and tumor cells were positive for B7-H3 expression; * (5) Subjects with relapsed/refractory acute myeloid leukemia who have failed standard treatment or lack effective treatment methods. * (6) Coagulation function, liver and kidney function, cardiopulmonary function meet requirements. * (7) Be able to understand the trial and have signed the informed consent form. Exclusion Criteria: * (1) Malignant tumors other than acute myeloid leukemia within 5 years before screening; * (2) Those who test positive for virus and syphilis; * (3) Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association \[NYHA\] classification≥ grade III), severe arrhythmia; * (4) Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment; * (5) Active infection or uncontrollable infection requiring systemic treatment within 7 days prior to screening; * (6) pregnant or lactating women, female subjects who planned to become pregnant within 2 years after cell reinfusion or male subjects whose partners planned to become pregnant within 2 years after their cell reinfusion; * (7) Subjects who were receiving systemic steroid therapy within 7 days prior to the year or who were judged by the investigator to require long-term systemic steroid therapy during treatment (other than inhalation or topical use); * (8) Have participated in other clinical studies within 1 month before screening; * (9) There was evidence of central nervous system invasion during subject screening, such as tumor cells detected in cerebrospinal fluid or imaging showing central infiltration; * (10) Those who have graft-versus-host response and need to use immunosuppressants; * (11) Those with a history of epilepsy or other central nervous system diseases; * (12) Patients with primary immunodeficiency diseases; * (13) situations that other investigators consider unsuitable for enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.