A Multi-Center Study of Multiple CAR T Cell Therapy for CD7-positive Hematological Malignancies
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Safety of infusion
Study Overview
Brief Summary
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cell therapy against CD7-positive hematological malignancies using CD7 specific CAR T cells. The study also aims to learn more about the function of CD7 CAR T cells and their persistence in patients of hematological malignancies.
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.
Hematological malignancies including T-cell acute lymphoblastic leukemia (T-ALL), T cell lymphoma (TCL), natural killer cell lymphoma (NKL) and acute myeloid leukemia (AML) are aggressive diseases which may express the early T cell development molecule CD7.
T-ALL represents 15% of childhood and 25% of adult ALL, and T-ALL patients are prone to early disease relapse and suffer from poor outcomes. Several immunophenotypic classifications have been proposed. According to European Group for the Immunological Characterization of Leukemias (EGIL), the presence of cytoplasmic or membrane expression of CD3 defines T-ALL. Four subgroups are proposed: (TI) the immature subgroup or pro-T-ALL is defined by the expression of CD7 and cCD3; (TII) pre-T-ALL also expresses CD2 and/or CD5 and/or CD8; (TIII) or cortical T-ALL shows CD1a positivity; (TIV) finally, mature T-ALL is characterized by the presence of surface CD3 and CD1a negativity.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age older than 6 months.
- •Confirmed expression of CD7 or additional surface antigens in the cancer cells by immuno-histochemical staining or flow cytometry.
- •Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 3 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 C virus (HCV) infection.
- •Pregnant or nursing women may not participate.
- •Use of glucocorticoid for systemic therapy within one week prior to entering the trial.
- •Previous treatment with any gene therapy products.
- •Patients, in the opinion of investigators, may not be able to comply with the study.
Arms & Interventions
Single arm
Multiple CAR T cells to treat CD7-positive hematological malignancies
Intervention: CD7-specific CAR gene-engineered T cells (Biological)
Outcomes
Primary Outcomes
Safety of infusion
Time Frame: a year
Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.
Secondary Outcomes
- Clinical response(a year)