UTAA06 injection for treating relapsed/refractory acute myeloid leukemia

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

This study is testing a new injection called UTAA06 to see if it can help people with relapsed or hard-to-treat acute myeloid leukemia feel better and respond well to treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chimeric antigen receptor
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05731219 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerance of UTAA06 injection in patients with relapsed or refractory acute myeloid leukemia that expresses the B7-H3 target. It is a single-arm, open-label, dose-escalation study that aims to assess the drug's efficacy and the behavior of CAR gdT cells after administration. Participants will receive varying doses of the injection, and the study will monitor for dose-limiting toxicities and overall patient response. The trial seeks to establish an appropriate clinical dose while ensuring patient safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory acute myeloid leukemia that is B7-H3 positive.

Not a fit: Patients who have not been diagnosed with B7-H3 positive acute myeloid leukemia or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat acute myeloid leukemia.

How similar studies have performed: While this approach is novel in targeting B7-H3 with CAR gdT cells, similar studies targeting other antigens have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18, regardless of gender;
2. Expected survival time ≥ 3 months;
3. ECOG score 0-1;
4. At screening, acute myeloid leukemia was definitely diagnosed, and B7-H3 expression in tumor cells was positive;
5. Patients with relapsed/refractory acute myeloid leukemia who failed to receive second-line or above standard treatment;
6. Coagulation function, liver and kidney function, heart and lung function meet the following requirements:

   1. Prothrombin time/international standardized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 ULN;
   2. Creatinine ≤ 1.5 ULN;
   3. Left ventricular ejection fraction ≥ 50%, no pericardial effusion is found in echocardiography, and no clinically significant abnormal wave band is found in electrocardiogram;
   4. Indoor baseline blood oxygen saturation\>92%;
   5. Total bilirubin ≤ 2 × ULN； ALT and AST ≤ 2.5 × ULN； The investigator judges the abnormality of ALT and AST caused by diseases (such as liver infiltration or bile duct obstruction), and the index can be broadened to ≤ 5 × ULN；
7. Be able to understand the test and have signed the informed consent form.

Exclusion Criteria:

1. In addition to adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery, patients with malignant tumors other than acute myeloid leukemia in the first 5 years of screening;
2. Hepatitis B surface antigen (HBsAg) positive and DNA positive; Hepatitis B core antibody (HBcAb) was positive and the copy number of HBV DNA in peripheral blood was greater than the lower limit of measurability; Hepatitis C virus (HCV) antibody positive and hepatitis C virus (HCV) RNA positive in peripheral blood; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Syphilis test positive;
3. Serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), and serious arrhythmia;
4. Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
5. Within 7 days before screening, there is active infection or uncontrollable infection requiring systemic treatment (except for mild genitourinary system infection and upper respiratory tract infection);
6. Pregnant or lactating women, female subjects planning pregnancy within 2 years after cell reinfusion or male subjects planning pregnancy within 2 years after their partners' cell reinfusion;
7. Subjects who are receiving systemic steroid treatment within 7 days before screening or need long-term use of systemic steroid treatment during treatment determined by the investigator (except for inhalation or local use);
8. Participated in other clinical studies within 1 month before screening;
9. During screening, there was evidence of central nervous system invasion, such as tumor cells detected in cerebrospinal fluid or imaging indicating central infiltration;
10. Those who have graft versus host reaction and need immunosuppressants;
11. People with epilepsy history or other central nervous system diseases;
12. Patients with primary immunodeficiency disease;
13. According to the judgment of the researcher, it does not conform to the situation of cell preparation;
14. Other researchers think it is not suitable to be included in the group.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital， Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: He Huang, doctor — Zhejiang University
• Study coordinator: He Huang, doctor

Conditions Relapsed/Refractory Acute Myeloid Leukemia; B7-H3 target