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Multi-CAR T Cell Therapy for Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03222674
Recruitment Status : Unknown
Verified October 2018 by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute.
Recruitment status was:  Recruiting
First Posted : July 19, 2017
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China
Yunnan Cancer Hospital
Information provided by (Responsible Party):
Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Biological: Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells Phase 1 Phase 2

Detailed Description:

Acute myeloid leukemia (AML) is a malignant disease characterized by the rapid growth of myeloblasts that build up in the bone marrow and interfere with the production of normal blood cells.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center Phase I/II Clinical Trial of Multi-CAR T Cell Therapy for Acute Myeloid Leukemia
Actual Study Start Date : July 15, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Single arm
CAR T cells to treat AML
 Biological: Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells
Infusion of Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells


Outcome Measures
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Primary Outcome Measures :
  1. percentage of patients with treatment related adverse effect [ Time Frame: a year ]
    percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical labs and so on.


Secondary Outcome Measures :
  1. Anti tumor activity of fourth generation CAR-T cells in patients with relapsed or refractory AML [ Time Frame: a year ]
    scale of CAR copies and leukemic cell burden (for efficacy)


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age older than 2 years.
  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:

  1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222674


Contacts
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Contact: Lung-Ji Chang 86-075586725195 c@szgimi.org

Locations
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China, Guangdong
Zhujiang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510282
Contact: Yuhua Li, M.D, Ph.D    86-13533706656    liyuhua2011gz@163.com   
Contact: Sanfang Tu, M.D, Ph.D    86-20-62782322    doctortutu@163.com   
Shenzhen Geno-immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, PhD    86-075586725195    c@szgimi.org   
China, Yunnan
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center Recruiting
KunMing, Yunnan, China, 650000
Contact: Xun Lai, MS    13577096609    1729112214@qq.com   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China
Yunnan Cancer Hospital
Investigators
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Principal Investigator: Lung-Ji Chang Shenzhen Geno-Immune Medical Institute
More Information
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Responsible Party: Lung-Ji Chang, President, Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT03222674    
Other Study ID Numbers: GIMI-IRB-17015
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute:
AML
CAR T
Muc1,CLL1, CD33, CD38, CD56, and/or CD123
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
 Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases