Universal CAR-T Cells Targeting AML
Universal CAR T Cells for the Treatment of Acute Myeloid Leukemia
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2023
CompletedFirst Posted
Study publicly available on registry
August 16, 2023
CompletedStudy Start
First participant enrolled
October 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
October 12, 2023
October 1, 2023
2.9 years
August 8, 2023
October 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of infusion
Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.
6 months
Secondary Outcomes (1)
Clinical response
1 year
Study Arms (1)
Multiple universal CAR T cells to treat AML
EXPERIMENTALInterventions
Infusion of CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells
Eligibility Criteria
You may qualify if:
- Age older than 6 months.
- Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts 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.
- Hgb≥80g/L.
- No cell separation contraindications.
- Abilities to understand and the willingness to provide written informed consent.
You may not qualify if:
- 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 active 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.
- The bone marrow AML burden (MRD) is above 50%.
- Patients, in the opinion of investigators, may not be able to comply with the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shenzhen Geno-Immune Medical Institute
Shenzhen, Guangdong, 518000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2023
First Posted
August 16, 2023
Study Start
October 31, 2023
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
October 12, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share