Multi-center Phase I/II Clinical Trial of Multi-CAR T Cell Therapy for Acute Myeloid Leukemia
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 10
- Locations
- 3
- Primary Endpoint
- percentage of patients with treatment related adverse effect
Study Overview
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.
Detailed Description
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •No cell separation contraindications.
- •Abilities to understand and the willingness to provide written informed consent.
Exclusion Criteria
- •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.
Arms & Interventions
Single arm
CAR T cells to treat AML
Intervention: Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells (Biological)
Outcomes
Primary Outcomes
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 Outcomes
- Anti tumor activity of fourth generation CAR-T cells in patients with relapsed or refractory AML(a year)
Investigators
Lung-Ji Chang
President
Shenzhen Geno-Immune Medical Institute