Evaluate the Safety and Efficacy of CLL1 CAR-T in Patients With R/R AML

NCT05467202 | Unknown Phase 1

• 1 other identifier: BG-CT-22-002(CLL1)
• 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 CLL1 CAR-T in patients with relapsed and refractory acute myeloid leukemia

Conditions

AML

Outcome Measures

Primary Outcomes (2)

• Evaluation of Safety

  Count the Incidence of adverse events

  Up to 2 years after CLL1 CAR-T infusion

• Changes in cytokine level after CLL1 CAR-T infusion

  Calculate the change of cytokine level in peripheral blood by flow cytometry after CLL1 CAR-T infusion. Cytokines include IL-2、IL-6、IL-10、IFN-γ.

  Up to 2 years after CLL1 CAR-T infusion

Secondary Outcomes (3)

• Complete response rate(CRR)

  Up to 2 years after CLL1 CAR-T infusion

• Partial response Rate (PRR)

  Up to 2 years after CLL1 CAR-T infusion

• Overall response Rate(ORR)

  Up to 2 years after CLL1 CAR-T infusion

Other Outcomes (6)

• Overall survival

  Up to 2 years after CLL1 CAR-T infusion

• Recurrence free survival (RFS)

  Up to 2 years after CLL1 CAR-T infusion

• Event-free survival (EFS)

  Up to 2 years after CLL1 CAR-T infusion

Study Arms (1)

Treatment group

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).

Drug: CLL1 CAR-T

Interventions

CLL1 CAR-T DRUG

A single infusion of autologous CLL1 CAR-T cells administered intravenously

Treatment group

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 CLL1 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)

The First Affiliated Hospital, Zhejiang University

Hangzhou, China

Location

Study Officials

• He Huang, MD

  The First Affiliated Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingming Zhang, MD

CONTACT

13656674208; mingmingzhang@zju.edu.cn

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 20, 2022
• Study Start: August 1, 2022
• Primary Completion: August 2, 2024
• Study Completion: August 2, 2025
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

CN (1)