Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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Eligible subjects will receive 1.0×10^8 CAR gdT, 2.0×10^8 CAR gdT, 4.0×10^8 CAR gdT, or additional doses may be added at the discretion of investigator and sponsor.

Official Title
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Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute

Conditions
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Relapsed/Refractory Acute Myeloid Leukemia

Intervention / Treatment
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* Biological: gdT cell injection targeting B7-H3 chimeric antigen receptor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gdT cell injection targeting B7-H3 chimeric atigen receptor<br>UTAA06 injection | Biological: gdT cell injection targeting B7-H3 chimeric antigen receptor<br>* The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 1E8, 2E8 and 4E8 CAR-gdT groups in order of sequence. And the subjects will be administered once.<br>* Other names: UTAA06 injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the safety after UTAA06 injection treatment (Safety) | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. | About 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate anti-tumor activity (overall survival) | Defined as the time from start of UTAA06 UTAA06 infusion therapy to death (due to any cause) | About 2 years | 
| To evaluate anti-tumor activity (duration of response) | Defined as the time from the first tumor assessment of CR or PR, CR or CRi to the first assessment of disease recurrence or progression or death (due to any cause). | About 2 years | 
| To evaluate anti-tumor activity (progression free survival) | Defined as the time from the start of UTAA06 infusion therapy to the first disease progression or recurrence or death from any cause. | About 2 years |