At a glance
ClinicalIndex Comparison RecordPhase 1Recruiting· 10 target
Drug / intervention
CLL-1, CD33 and/or CD123-specific CAR gene-engineered T cellsbiological
Likely dose
Not stated in record
Key inclusion· 5
- ✓Age older than 6 months
- ✓Confirmed expression of CLL-1, CD123 and/or CD33 in blast AML by immuno-histochemical staining or flow cytometry
- ✓Adequate bone marrow, liver and renal function per specified lab requirements
- ✓Ability to understand and provide written informed consent
Key exclusion· 7
- ✕Severe illness or medical condition that would not permit management per protocol, including active uncontrolled infection
- ✕Active bacterial, fungal or viral infection not controlled by adequate treatment
- ✕Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) 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 Multiple CAR T Cells for Treating Acute Myeloid Leukemia
In Brief
A Phase 1 clinical trial evaluating CLL-1, CD33 and/or CD123-specific CAR 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 multiple CAR T-cell therapy which combines CAR T cells against CLL-1 with CAR T cells targeting CD123 or CD33 in patients with relapsed and refractory AML. The study also aims to learn more about the function of CAR T cells and their persistency in AML patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesChina
Collaborators--
Timeline
Phase 1Recruiting
20202021202220232024202520262027202820292030
First PostedJul 2019
Enrollment StartAug 2025
TodayJul 2026
Primary CompletionJul 2028
Study CompletionDec 2029
First PostedJul 8, 2019
Enrollment StartAug 1, 2025
Primary CompletionJul 31, 2028
Study CompletionDec 31, 2029
TodayJul 1, 2026
Enrollment to primary: 3 yearsPosted 7.0 years agoPrimary completion in 2.1 years
Arms & Interventions
Multiple CAR T cells to treat AMLexperimental
Multiple CAR T cells to treat AML
Biological: CLL-1, CD33 and/or CD123-specific CAR gene-engineered T cells
Interventions
CLL-1, CD33 and/or CD123-specific CAR gene-engineered T cellsbiological
Infusion of CLL-1, CD33 and/or CD123-specific CAR-T cells