Multi-CAR T Cell Therapy for Acute Myeloid Leukemia

NCT03222674 | Recruiting Phase 1

• 1 other identifier: GIMI-IRB-17015
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multi-CAR T cell therapy targeting different AML surface antigens in patients with relapsed or refractory acute myeloid leukemia (AML). Another goal of the study is to learn more about the function of the multi-CAR T cells and their persistency in the patients.

Conditions

Acute Myeloid Leukemia

Keywords

AML; CAR T; Muc1,CLL1, CD33, CD38, CD56, and/or CD123

Outcome Measures

Primary Outcomes (1)

• percentage of patients with treatment related adverse effect

  percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical labs and so on.

  a year

Secondary Outcomes (1)

• Anti tumor activity of fourth generation CAR-T cells in patients with relapsed or refractory AML

  a year

Study Arms (1)

Single arm

EXPERIMENTAL

CAR T cells to treat AML

Biological: Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells

Interventions

Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells BIOLOGICAL

Infusion of Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells

Single arm

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 2 years.
• CD33, CD38, CD56, CD123, MucI, and CLL1 expression can be identified in the malignant cells by immuno-histochemical staining or flow cytometry.
• Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 2 months.
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL.
• Hgb≥80g/L.
• No cell separation contraindications.
• Abilities to understand and the willingness to provide written informed consent.

You may not qualify if:

• Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
• Active bacterial, fungal or viral infection not controlled by adequate treatment.
• Known HIV or hepatitis B virus (HBV) infection.
• Pregnant or nursing women may not participate.
• History of glucocorticoid for systemic therapy within the week prior to entering the test.
• Previously treatment with any gene therapy products.
• Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead
• Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China: collaborator
• Yunnan Cancer Hospital: collaborator

Study Sites (3)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

Kunming, Yunnan, 650000, China

RECRUITING

Related Publications (1)

• Pei K, Xu H, Wang P, Gan W, Hu Z, Su X, Zhang H, He Y. Anti-CLL1-based CAR T-cells with 4-1-BB or CD28/CD27 stimulatory domains in treating childhood refractory/relapsed acute myeloid leukemia. Cancer Med. 2023 Apr;12(8):9655-9661. doi: 10.1002/cam4.5916. Epub 2023 Apr 9.

  PMID: 37031462 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

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

Study Officials

• Lung-Ji Chang

  Shenzhen Geno-Immune Medical Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lung-Ji Chang

CONTACT

86-075586725195; c@szgimi.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 19, 2017
• Study Start: July 15, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)