Study Results
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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UNKNOWN
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2017-07-15
2020-12-31
Brief Summary
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Detailed Description
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In this study, the patients' own T cells will be genetically modified with lentiviral vectors expressing chimeric antigen receptors. The multi-CAR T cells recognize specific molecules such as CD33, CD38, CD123, CD56, MucI, and CLL1, which are often found expressed on the surface of AML cells. The engineered CAR T cells will be infused into patients.
The purpose of this clinical study is to assess the feasibility, safety and efficacy of the multi-CAR T cell therapy against 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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm
CAR T cells to treat AML
Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells
Infusion of Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells
Interventions
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Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells
Infusion of Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells
Eligibility Criteria
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Inclusion Criteria
2. CD33, CD38, CD56, CD123, MucI, and CLL1 expression can be identified in the malignant cells by immuno-histochemical staining or flow cytometry.
3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 2 months.
4. 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.
5. Hgb≥80g/L.
6. No cell separation contraindications.
7. Abilities to understand and the willingness to provide written informed consent.
Exclusion Criteria
2. Active bacterial, fungal or viral infection not controlled by adequate treatment.
3. Known HIV or hepatitis B virus (HBV) infection.
4. Pregnant or nursing women may not participate.
5. History of glucocorticoid for systemic therapy within the week prior to entering the test.
6. Previously treatment with any gene therapy products.
7. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
2 Years
75 Years
ALL
No
Sponsors
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Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China
UNKNOWN
Yunnan Cancer Hospital
OTHER
Shenzhen Geno-Immune Medical Institute
OTHER
Responsible Party
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Lung-Ji Chang
President
Principal Investigators
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Lung-Ji Chang
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Geno-Immune Medical Institute
Locations
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Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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GIMI-IRB-17015
Identifier Type: -
Identifier Source: org_study_id
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