This is a prospective, single-arm, open-label, single dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-AMDR cells in subjects with relapsed/refractory Acute Myeloid Leukemia who received adequate standard therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Subjects will receive a conditioning regimen before treatment with LCAR-AMDR cells
Beijing Gobroad BoRen Hospital
Beijing, Beijing Municipality, China
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment
Time frame: Time Frame: Minimum 2 years after LCAR-AMDR infusion (Day 1)
Recommended Phase 2 dose (RP2D) finding
RP2D established through ATD+BOIN design
Time frame: 30 days after LCAR-AMDR infusion (Day 1)
CAR positive T cells and CAR transgene levels in peripheral blood and bone marrow
CAR positive T cells and CAR transgene levels in peripheral blood and bone marrow after LCAR-AMDR infusion
Time frame: 2 years after LCAR-AMDR infusion (Day 1)
Overall response rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or CRi after treatment via LCAR-AMDR cell infusion
Time frame: 2 years after LCAR-AMDR infusion (Day 1)
Time to Response (TTR)
Time to Response (TTR) is defined as the time from the date of first infusion of LCAR-AMDR to the date of the first response evaluation of the subject who has met all criteria for CR or CRi.
Time frame: 2 years after LCAR-AMDR infusion (Day 1)
Duration of Response (DoR)
Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or CRi) to the first documented relapse evidence of the responders
Time frame: Minimum 2 years after LCAR-AMDR infusion (Day 1)
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Event-free survival (EFS)
Event-free survival (EFS) is defined as the time from the date of first infusion of the LCAR-AMDR to the first documented treatment failure, disease relapse or death (due to any cause), whichever occurs first
Time frame: Minimum 2 years after LCAR-AMDR infusion (Day 1)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-AMDR to death of the subject
Time frame: Minimum 2 years after LCAR-AMDR infusion (Day 1)
The proportion of subjects who achieve CR or Cri and obtain bone marrow MRD negative.
The proportion of subjects who achieve CR or Cri and obtain bone marrow MRD negative.
Time frame: Minimum 2 years after LCAR-AMDR infusion (Day 1)
Incidence of anti-LCAR-AMDR antibody and positive sample titer
Venous blood samples will be collected to measure LCAR-AMDR positive cell concentrations and the transgenic level of LCAR-AMDR, at the time points when anti-LCAR-AMDR antibody serum samples are evaluated
Time frame: Minimum 2 years after LCAR-AMDR infusion (Day 1)