Back to resultsAnti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)
Primary Purpose
Acute Myeloid Leukemia
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
anti-CLL1 CART
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring CLL1, CART, AML
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- The First Affiliated Hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CLL1 positive relapsed or refractory acute myeloid leukemia
Arm Description
Outcomes
Primary Outcome Measures
Number of Adverse Events
Adverse events are evaluated with CTCAE V5.0
Secondary Outcome Measures
Overall response rate (ORR)
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
overall survival (OS)
The date of enrollment to the date of death from any cause
Event-free survival (EFS)
Time from enrollment to the date of primary refractory disease, or relapse from CR or CRi, or death from any cause
Cumulative incidence of relapse(CIR)
Time from the date of achievement of a remission to the date of relapse
Full Information
NCT ID
NCT04884984
First Posted
May 10, 2021
Last Updated
May 10, 2021
Sponsor
The First Affiliated Hospital of Soochow University
1. Study Identification
Unique Protocol Identification Number
NCT04884984
Brief Title
Anti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
The patients will receive infusion of anti-CLL1 CAR T-cells to confirm the safety and efficacy of anti-CLL1 CAR T-cells in relapsed or refractory acute myeloid leukemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
CLL1, CART, AML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CLL1 positive relapsed or refractory acute myeloid leukemia
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
anti-CLL1 CART
Intervention Description
Split intravenous infusion of anti-CLL1 CAR T cells [dose escalating infusion of (5-20)x10^6 anti-CLL1 CAR T cells/kg].
Primary Outcome Measure Information:
Title
Number of Adverse Events
Description
Adverse events are evaluated with CTCAE V5.0
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Time Frame
2 years
Title
overall survival (OS)
Description
The date of enrollment to the date of death from any cause
Time Frame
2 years
Title
Event-free survival (EFS)
Description
Time from enrollment to the date of primary refractory disease, or relapse from CR or CRi, or death from any cause
Time Frame
2 years
Title
Cumulative incidence of relapse(CIR)
Description
Time from the date of achievement of a remission to the date of relapse
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaowen Tang, Ph.D
Phone
(0086)51267781856
Email
xwtang1020@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Yu, Ph.D
Phone
(0086)13818629089
Email
ylyh188@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaowen Tang, Ph.D
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaowen Tang, Ph.D
Phone
(0086) 51267781856
Email
xwtang1020@163.com
12. IPD Sharing Statement
Learn more about this trial
Anti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)
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