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

PersonGen BioTherapeutics

Status and phase

Enrolling

Early Phase 1

Conditions

Relapsed/Refractory Acute Myeloid Leukemia

Treatments

Biological: gdT cell injection targeting B7-H3 chimeric antigen receptor

Study type

Interventional

Funder types

Industry

Identifiers

NCT05722171

PG-p002-015

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.