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

NCT05731219 | Unknown Phase 1

• 1 other identifier: PG-pCAR-gdT-TAA06-017
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Main research purpose： Evaluate the safety and tolerance of UTAA06 injection in the treatment of patients with relapsed/refractory acute myeloid leukemia. Secondary research purpose： Evaluate the expansion and persistence of gdT cells targeting B7-H3 chimeric antigen receptor after UTAA06 injection administration in vivo; Evaluate the efficacy of UTAA06 injection in the treatment of patients with relapsed/refractory acute myeloid leukemia; Evaluate the content of B7-H3 positive cells in the peripheral blood after administration of UTAA06 injection; Evaluate the immunogenicity of UTAA06 injection.

Conditions

Relapsed/Refractory Acute Myeloid Leukemia

Keywords

B7-H3 target

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To evaluate anti-tumor activity (overall survival)

  About 2 years

• To evaluate anti-tumor activity (duration of response)

  About 2 years

• To evaluate anti-tumor activity (progression free survival)

  About 2 years

Study Arms (1)

B7-H3 target, CAR gene modified gdT cell injection

EXPERIMENTAL

UTAA06 injection After the subjects who signed the informed consent form were screened by the inclusion/exclusion criteria, the qualified subjects will enter 1.0 in order of priority × 10\^8，3.0 × 10\^8 and 6.0 × 10\^8 CAR gdT groups were administered once.

Biological: B7-H3 target, CAR gene modified gdT cell injection

Interventions

B7-H3 target, CAR gene modified gdT cell injection BIOLOGICAL

After the subjects who signed the informed consent form were screened by the inclusion/exclusion criteria, the qualified subjects will enter 1.0 in order of priority × 108，3.0 × 108 and 6.0 × 108 CAR gdT groups were administered once.

Also known as: UTAA06 injection

B7-H3 target, CAR gene modified gdT cell injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18, regardless of gender;
• Expected survival time ≥ 3 months;
• ECOG score 0-1;
• At screening, acute myeloid leukemia was definitely diagnosed, and B7-H3 expression in tumor cells was positive;
• Patients with relapsed/refractory acute myeloid leukemia who failed to receive second-line or above standard treatment;
• Coagulation function, liver and kidney function, heart and lung function meet the following requirements:
• Prothrombin time/international standardized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 ULN;
• Creatinine ≤ 1.5 ULN;
• Left ventricular ejection fraction ≥ 50%, no pericardial effusion is found in echocardiography, and no clinically significant abnormal wave band is found in electrocardiogram;
• Indoor baseline blood oxygen saturation\>92%;
• 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；
• Be able to understand the test and have signed the informed consent form.

You may not qualify if:

• 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;
• 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;
• 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;
• Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
• 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);
• 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;
• 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);
• Participated in other clinical studies within 1 month before screening;
• During screening, there was evidence of central nervous system invasion, such as tumor cells detected in cerebrospinal fluid or imaging indicating central infiltration;
• Those who have graft versus host reaction and need immunosuppressants;
• People with epilepsy history or other central nervous system diseases;
• Patients with primary immunodeficiency disease;
• According to the judgment of the researcher, it does not conform to the situation of cell preparation;
• Other researchers think it is not suitable to be included in the group.

Sponsors & Collaborators

• PersonGen BioTherapeutics (Suzhou) Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital， Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• He Huang, doctor

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, doctor

CONTACT

13605714822; hehuangyu@126.com

Huimin Meng, doctor

CONTACT

18015580390; huimin.meng@persongen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: UTAA06 injection

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 16, 2023
• Study Start: September 26, 2022
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2025
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

CN (1)