Evaluate the Safety and Efficacy of ADGRE2 CAR-T in Patients With R/R AML

NCT05463640 | Unknown Phase 1

• 1 other identifier: BG-CT-22-002(ADGRE2)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, phase I study to assess the safety and efficacy of ADGRE2 CAR-T in patients with relapsed and refractory acute myeloid leukemia

Conditions

AML

Outcome Measures

Primary Outcomes (2)

• Changes in cytokine level after ADGRE2 CAR-T infusion.

  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.

  Up to 2 years after ADGRE2 CAR-T infusion

• The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion.

  Track CAR-T cells expansion in patients after infusion by flow cytometry and qPCR.

  Up to 2 years after ADGRE2 CAR-T infusion

Secondary Outcomes (3)

• Complete response rate(CRR)

  Up to 2 years after ADGRE2 CAR-T infusion

• Partial response Rate (PRR)

  Up to 2 years after ADGRE2 CAR-T infusion

• Overall response Rate(ORR)

  Up to 2 years after ADGRE2 CAR-T infusion

Other Outcomes (6)

• Overall survival

  Up to 2 years after ADGRE2 CAR-T infusion

• Recurrence free survival (RFS)

  Up to 2 years after ADGRE2 CAR-T infusion

• Event-free survival (EFS)

  Up to 2 years after ADGRE2 CAR-T infusion

Study Arms (1)

ADGRE2 CAR-T

EXPERIMENTAL

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).

Biological: ADGRE2 CAR-T

Interventions

ADGRE2 CAR-T BIOLOGICAL

ADGRE2 CAR-T is a new type CAR-T cells therapy for patients with acute myeloid leukemia.

ADGRE2 CAR-T

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Mingming Zhang Zhang

Hangzhou, China

Location

Study Officials

• He Huang, MD

  The first hospital affiliated Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingming Zhang, MD

CONTACT

13656674208; mingmingzhang@zju.edu.cn

He Huang, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 19, 2022
• Study Start: August 2, 2022
• Primary Completion: August 2, 2024
• Study Completion: August 2, 2025
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

CN (1)