Anti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)
Pilot Study of the Safety and Efficacy of Anti-CLL1 Chimeric Antigen Receptor Engineered T-Cells in the Treatment of CLL1 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
1 other identifier
interventional
20
1 country
1
Brief Summary
This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of anti-CLL1 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CLL1 positive relapsed or refractory acute myeloid leukemia.
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 Jul 2017
Longer than P75 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
Study Start
First participant enrolled
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 10, 2021
CompletedFirst Posted
Study publicly available on registry
May 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMay 13, 2021
May 1, 2021
5.5 years
May 10, 2021
May 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Adverse Events
Adverse events are evaluated with CTCAE V5.0
12 months
Secondary Outcomes (4)
Overall response rate (ORR)
2 years
overall survival (OS)
2 years
Event-free survival (EFS)
2 years
Cumulative incidence of relapse(CIR)
2 years
Study Arms (1)
CLL1 positive relapsed or refractory acute myeloid leukemia
EXPERIMENTALInterventions
Split intravenous infusion of anti-CLL1 CAR T cells \[dose escalating infusion of (5-20)x10\^6 anti-CLL1 CAR T cells/kg\].
Eligibility Criteria
You may qualify if:
- CLL1 positive relapsed/refractory acute myeloid leukemia
- Age 6-65 years
- Left ventricular ejection fractions ≥ 0.5 by echocardiography
- Creatinine \< 1.6 mg/dL
- Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal
- Total bilirubin \<2.0 mg/dL
- Karnofsky performance status ≥ 60
- Expected survival time ≥ 3 months (according to investigator's judgement)
You may not qualify if:
- Patients are pregnant or lactating
- Uncontrolled active infection
- Class III/IV cardiovascular disability according to the New York Heart Association Classification
- Active hepatitis B or hepatitis C infection
- Patients with HIV infection
- Patients with history of seizure
- Active central nervous system leukemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaowen Tang, Ph.D
The First Affiliated Hospital of Soochow University
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
May 10, 2021
First Posted
May 13, 2021
Study Start
July 1, 2017
Primary Completion
December 31, 2022
Study Completion
December 31, 2024
Last Updated
May 13, 2021
Record last verified: 2021-05