Not provided
Not provided
Not provided
Not provided
Not provided
Both the sponsors and collaborator are considering terminating the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nanjing Legend Biotech Co. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCAR-AMDR Cells Product | Experimental | Each subject will be treated with LCAR-AMDR Cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCAR-AMDR Cells Product | Biological | Subjects will receive a conditioning regimen before treatment with LCAR-AMDR cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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: Minimum 2 years after LCAR-AMDR infusion (Day 1) |
| Recommended Phase 2 dose (RP2D) finding | RP2D established through ATD+BOIN design | 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 | 2 years after LCAR-AMDR infusion (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years after LCAR-AMDR infusion (Day 1) |
| Time to Response (TTR) |
Not provided
Inclusion Criteria:
The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF)(For minors, the guardian shall also provide written informed consent ); Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease;
Age 14-60 years;
ECOG score: ≤2;
Relapsed/refractory AML must meet one of the following conditions:
Meet the requirements of allogeneic HSCT
Expected survival ≥ 3 months;
Exclusion Criteria:
Subject with APL/AML-M3:t(15;17)(q22;q12)
Received any of the following treatments:
Prior antitumor therapy with insufficient washout period;
CNS infiltration; Except for patients with prior CNS infiltration who are currently in remission;
HBsAg, HBV DNA, HCV-Ab, HCV RNA or HIV-Ab positive;
Pregnant or breast-feeding women;
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Gobroad BoRen Hospital | Beijing | Beijing Municipality | 100070 | China | ||
| Chinese Academy of Medical Science and Blood Disease Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| 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 | Minimum 2 years after LCAR-AMDR infusion (Day 1) |
| 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 | 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 | 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. | 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 | Minimum 2 years after LCAR-AMDR infusion (Day 1) |
| Tianjin |
| Tianjin Municipality |
| 300020 |
| China |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |