- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05463640
Evaluate the Safety and Efficacy of ADGRE2 CAR-T in Patients With R/R AML
To Evaluate the Safety and Efficacy of ADGRE2 CAR-T in Patients With Relapsed and Refractory Acute Myeloid Leukemia
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Hangzhou, China
- Mingming Zhang Zhang
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;
- Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
- The expression of ADGRE2 in AML blast is positive ;
- The patient has recovered from the toxicity of previous treatment;
- ECOG score ≤ 2 and expected survival period is not less than 3 months;
Adequate organ function defined as:
AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL/min; Hemoglobin ≥60g/L ; Indoor oxygen saturation ≥92%; LVEF≥45%;
- Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;
- From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception
Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia;
- History or presence of a CNS disorder;
- HBsAg or HBcAb are positive; HCV 、HIV and Syphilis antibody are positive, CMV DNA in peripheral blood is more than≥500 copies /mL;
- History of severe hypersensitivity reaction;
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment;
- History of organ transplant surgery;
- Required systemic application of immunosuppressive or other drugs;
- Auto-SCT within the 3 months before enrollment;
- Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES));
- Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) ;
- Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management;
- Live vaccine received within the ≤ 4 weeks before enrollment;
- Persons with serious mental illness;
- History of major surgical operations four weeks before enrollment;
- History of alcoholism or substance abuse;
- Was identified by the investigators as unsuitable to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ADGRE2 CAR-T
Dose Escalation:After enrollment ,Participants complete the PBMC apheresis,then complete the Lymphocyte clearance,and then receive the dose climning test: 3×10e6/kg,6 ×10e6/kg,9×10e6/kg. Dose Expansion:Participants receive a single dose (at the MTD determined). |
ADGRE2 CAR-T is a new type CAR-T cells therapy for patients with acute myeloid leukemia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in cytokine level after ADGRE2 CAR-T infusion.
Time Frame: Up to 2 years after ADGRE2 CAR-T infusion
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Calculate the change of cytokine level in peripheral blood by flow cytometry after CAR-T infusion.
Cytokines include IL-2、IL-6、TNF-α、IFN-γ.
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Up to 2 years after ADGRE2 CAR-T infusion
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The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion.
Time Frame: Up to 2 years after ADGRE2 CAR-T infusion
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Track CAR-T cells expansion in patients after infusion by flow cytometry and qPCR.
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Up to 2 years after ADGRE2 CAR-T infusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response rate(CRR)
Time Frame: Up to 2 years after ADGRE2 CAR-T infusion
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Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
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Up to 2 years after ADGRE2 CAR-T infusion
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Partial response Rate (PRR)
Time Frame: Up to 2 years after ADGRE2 CAR-T infusion
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Proportion of subjects who achieved a partial response (PR)
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Up to 2 years after ADGRE2 CAR-T infusion
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Overall response Rate(ORR)
Time Frame: Up to 2 years after ADGRE2 CAR-T infusion
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Proportion of subjects who achieved CR, CRi, or PR
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Up to 2 years after ADGRE2 CAR-T infusion
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: Up to 2 years after ADGRE2 CAR-T infusion
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Death from any cause from the beginning of cell transfusion
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Up to 2 years after ADGRE2 CAR-T infusion
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Recurrence free survival (RFS)
Time Frame: Up to 2 years after ADGRE2 CAR-T infusion
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From remission to relapse or death of the subject (including all causes), whether the subject relapsed or died is unknown until the date of the last follow-up examination.
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Up to 2 years after ADGRE2 CAR-T infusion
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Event-free survival (EFS)
Time Frame: Up to 2 years after ADGRE2 CAR-T infusion
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Counting from the beginning of cell transfusion until treatment failure, recurrence, or death (various causes).
Subjects without any of these events were counted up to the last follow-up examination date.
For patients without CR or CRi, EFS is calculated from the beginning of cell transfusion until disease progression or death.
Based on the initial event.
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Up to 2 years after ADGRE2 CAR-T infusion
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MRD negative rate
Time Frame: Up to 2 years after ADGRE2 CAR-T infusion
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The rate of MRD negative subjects was determined by flow cytometry.
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Up to 2 years after ADGRE2 CAR-T infusion
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Median BM Reduction
Time Frame: Up to 2 years after ADGRE2 CAR-T infusion
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Changes of bone marrow primitive cells after cell transfusion from baseline.
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Up to 2 years after ADGRE2 CAR-T infusion
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Percentage of subjects disengaged from transfusion
Time Frame: Up to 2 years after ADGRE2 CAR-T infusion
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Percentage of baseline transfusion-dependent subjects who were discharged from transfusion after cell transfusion.
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Up to 2 years after ADGRE2 CAR-T infusion
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BG-CT-22-002(ADGRE2)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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