Evaluate the Safety and Efficacy of CD33 CAR-T in Patients With R/R AML

NCT ID: NCT05473221

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2025-08-02

Brief Summary

This is an open label, phase I study to assess the safety and efficacy of CD33 CAR-T in patients with relapsed and refractory acute myeloid leukemia

Conditions

AML

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CD33 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).

Group Type: EXPERIMENTAL

CD33 CAR-T

Intervention Type: BIOLOGICAL

CD33 CAR-T is a new type CAR-T cells therapy for patients with acute myeloid leukemia.

Interventions

CD33 CAR-T

CD33 CAR-T is a new type CAR-T cells therapy for patients with acute myeloid leukemia.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;

2. Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);

3. The expression of CD33 in AML blast is positive ;

4. The patient has recovered from the toxicity of previous treatment;

5. ECOG score ≤ 2 and expected survival period is not less than 3 months;

6. 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%;

7. Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;

8. 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

1. Diagnosis of acute promyelocytic leukemia;

2. History or presence of a CNS disorder;

3. HBsAg or HBcAb are positive; HCV 、HIV and Syphilis antibody are positive, CMV DNA in peripheral blood is more than≥500 copies /mL;

4. History of severe hypersensitivity reaction;

5. 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;

6. History of organ transplant surgery;

7. Required systemic application of immunosuppressive or other drugs;

8. Auto-SCT within the 3 months before enrollment;

9. 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));

10. Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) ;

11. Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management;

12. Live vaccine received within the ≤ 4 weeks before enrollment;

13. Persons with serious mental illness;

14. History of major surgical operations four weeks before enrollment;

15. History of alcoholism or substance abuse;

16. Was identified by the investigators as unsuitable to participate in the study

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

He Huang, MD

Role: PRINCIPAL_INVESTIGATOR

The first hospital affiliated Zhejiang University

Locations

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Mingming Zhang, MD

Role: CONTACT

mingmingzhang@zju.edu.cn

13656674208

He Huang, MD

Role: CONTACT

Other Identifiers

BG-CT-22-002(CD33)

Identifier Type: -

Identifier Source: org_study_id