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Universal CAR-T Cells Targeting AML

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05995041
Recruitment Status : Recruiting
First Posted : August 16, 2023
Last Update Posted : October 12, 2023
Sponsor:
Information provided by (Responsible Party):
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 universal CAR T-cell products targeting CLL-1, CD33, CD38 and CD123 in patients with relapsed and refractory AML. The study also aims to learn more about the function of the universal CAR T cells and their persistency in AML patients.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Biological: CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells Phase 1

Detailed Description:

Acute myeloid leukemia (AML) is a malignant disease characterized by the rapid growth of myeloblasts that grow in the bone marrow and interferes with the generation of normal blood cells.Over the past years, several groups have demonstrated that CLL1, CD33, CD38 and CD123 are potential AML targets. CLL-1 (C-type lectin-like molecule-1) is a transmembrane glycoprotein, which is overexpressed in leukemic stem cells but absent in normal hematopoietic stem cells, suggesting that CLL-1 can be a promising target for targeted AML therapy. Although CAR-T cells have shown impressive anti-leukemic effect in B cell disease, CAR-T treatment for AML has proven to be more difficult. One of the reasons is because AML patients often has highly suppressed bone marrow function, and it is often difficult to obtain good quality of T cells for CAR-T preparation. In addition, AML progression can be acute and rapid, which can outpace the CAR-T expansion, and the time-consuming CAR-T manufacture process makes it more difficult to treat AML with autologous source of T cells By using universal type of CAR-T cells, the product can be supplied off-the-shelf without being customized from individual patients. In addition, the immediate availability means that patients with short disease remission time under severe bone marrow suppression may get a chance to be treated with CAR-T cells to achieve disease remission. In addition, those patients who suffer from long-term immunosuppression due to tumor microenvironment or myelosuppressive chemotherapy would have the option of treatment with the universal CAR-T cells.

The purpose of this study is to assess the feasibility, safety and efficacy of several AML-specific universal CAR-T products. Another goal is to learn more about the function of the universal CAR T cells and their persistency in the patients.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Universal CAR T Cells for the Treatment of Acute Myeloid Leukemia
Estimated Study Start Date : October 31, 2023
Estimated Primary Completion Date : September 30, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Multiple universal CAR T cells to treat AML Biological: CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells
Infusion of CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells


Outcome Measures
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Primary Outcome Measures :
  1. Safety of infusion [ Time Frame: 6 months ]
    Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.


Secondary Outcome Measures :
  1. Clinical response [ Time Frame: 1 year ]
    Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age older than 6 months.
  2. Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by immuno-histochemical staining or flow cytometry.
  3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 3 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 active hepatitis C virus (HCV) infection.
  4. Pregnant or nursing women may not participate.
  5. Use of glucocorticoid for systemic therapy within one week prior to entering the trial.
  6. Previous treatment with any gene therapy products.
  7. The bone marrow AML burden (MRD) is above 50%.
  8. Patients, in the opinion of investigators, may not be 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): NCT05995041


Contacts
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Contact: Lung-Ji Chang, Ph.D 86-0755-8672 5195 c@szgimi.org
Contact: Ying Deng 86-0755-8672 5195 ying.deng@szgimi.org

Locations
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China, Guangdong
Shenzhen Geno-Immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, Ph.D    86-0755-8672 5195    c@szgimi.org   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
More Information
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Responsible Party: Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT05995041    
Other Study ID Numbers: GIMI-IRB-23004
First Posted: August 16, 2023    Key Record Dates
Last Update Posted: October 12, 2023
Last Verified: October 2023
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 Shenzhen Geno-Immune Medical Institute:
AML
Universal CAR T
CD33, CD123, CD38, CLL-1
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
 Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases