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

NCT ID: NCT05654779

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-12

Study Completion Date

2023-09-26

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LCAR-AMDR Cells Product

Each subject will be treated with LCAR-AMDR Cells

Group Type EXPERIMENTAL

LCAR-AMDR Cells Product

Intervention Type BIOLOGICAL

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

Interventions

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LCAR-AMDR Cells Product

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. 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;
2. Age 14-60 years;
3. ECOG score: ≤2;
4. Relapsed/refractory AML must meet one of the following conditions:

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

Exclusion Criteria

1. Subject with APL/AML-M3:t(15;17)(q22;q12)
2. Received any of the following treatments:

* Previous gene therapy
* Previous anti CD33/CLL1 therapy
* Previous any target CAR-T cells therapy
3. Prior antitumor therapy with insufficient washout period;
4. CNS infiltration; Except for patients with prior CNS infiltration who are currently in remission;
5. HBsAg, HBV DNA, HCV-Ab, HCV RNA or HIV-Ab positive;
6. Pregnant or breast-feeding women;
Minimum Eligible Age

14 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Legend Biotech Co.

INDUSTRY

Sponsor Role collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Gobroad BoRen Hospital

Beijing, Beijing Municipality, China

Site Status

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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LB2202-0001

Identifier Type: -

Identifier Source: org_study_id