CLL-1/CD33 Targeted LCAR-AMDR Cells in Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT05654779 | Terminated Phase 1

• 1 other identifier: IIT2022043
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (7)

• Overall response rate (ORR)

  2 years after LCAR-AMDR infusion (Day 1)

• Time to Response (TTR)

  2 years after LCAR-AMDR infusion (Day 1)

• Duration of Response (DoR)

  Minimum 2 years after LCAR-AMDR infusion (Day 1)

• Event-free survival (EFS)

  Minimum 2 years after LCAR-AMDR infusion (Day 1)

• Overall Survival (OS)

  Minimum 2 years after LCAR-AMDR infusion (Day 1)

Study Arms (1)

LCAR-AMDR Cells Product

EXPERIMENTAL

Each subject will be treated with LCAR-AMDR Cells

Biological: LCAR-AMDR Cells Product

Interventions

LCAR-AMDR Cells Product BIOLOGICAL

Subjects will receive a conditioning regimen before treatment with LCAR-AMDR cells

LCAR-AMDR Cells Product

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• Twice or more relapse;
• Newly diagnosed AML patients who failed after 2 cycles of standard chemotherapy;
• Relapse within 12 months after CR, or relapse after 12 months with CR but failed to respond to conventional chemotherapy;
• Persistent extramedullary leukemia.
• Meet the requirements of allogeneic HSCT
• Expected survival ≥ 3 months;

You may not qualify if:

• Subject with APL/AML-M3:t(15;17)(q22;q12)
• Received any of the following treatments:
• Previous gene therapy
• Previous anti CD33/CLL1 therapy
• Previous any target CAR-T cells therapy
• 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;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Nanjing Legend Biotech Co.: collaborator

Study Sites (2)

Beijing Gobroad BoRen Hospital

Beijing, Beijing Municipality, 100070, China

Location

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: December 12, 2022
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)