Clinical trial NCT05722171: Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Official title: Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Relapsed/Refractory Acute Myeloid Leukemia
Lead sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of the safety after UTAA06 injection treatment (Safety)
timeFrame: About 2 years
Secondary outcomes:
measure: To evaluate anti-tumor activity (overall survival)
timeFrame: About 2 years
measure: To evaluate anti-tumor activity (duration of response)
timeFrame: About 2 years
measure: To evaluate anti-tumor activity (progression free survival)
timeFrame: About 2 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: PersonGen Anke Cellular Therapeutice Co., Ltd.
state: Anhui
Study officials:
affiliation: Wuhan Union Hospital, China
name: Heng Mei, Doctor
role: PRINCIPAL_INVESTIGATOR
References: