At a glance
ClinicalIndex Comparison RecordPhase 1Recruiting· 10 target
Drug / intervention
Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cellsbiological
Likely dose
Not stated in record
Key inclusion· 7
- ✓Age older than 2 years
- ✓CD33, CD38, CD56, CD123, MucI, and CLL1 expression identifiable by immuno-histochemical staining or flow cytometry
- ✓Karnofsky performance status (KPS) score higher than 80 with life expectancy >2 months
- ✓Cardiac ejection fraction ≥50%, oxygen saturation ≥90%
Key exclusion· 7
- ✕Severe illness or medical condition that would not permit protocol management, 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
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-center Phase I/II Clinical Trial of Multi-CAR T Cell Therapy for Acute Myeloid Leukemia
In Brief
A Phase 1 clinical trial evaluating Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells for Acute Myeloid Leukemia. Currently recruiting, targeting 10 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesChina
Collaborators--
Timeline
Phase 1Recruiting
201820192020202120222023202420252026202720282029
First PostedJul 2017
Enrollment StartJul 2025
TodayJul 2026
Primary CompletionJun 2028
Study CompletionDec 2028
First PostedJul 19, 2017
Enrollment StartJul 15, 2025
Primary CompletionJun 30, 2028
Study CompletionDec 31, 2028
TodayJul 1, 2026
Enrollment to primary: 3.0 yearsPosted 9.0 years agoPrimary completion in 2.0 years
Arms & Interventions
Single armexperimental
CAR T cells to treat AML
Biological: Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells
Interventions
Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cellsbiological
Infusion of Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells