Administration of Anti-siglec-6 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)

NCT ID: NCT05488132

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-03-31

Brief Summary

To evaluate the safety and efficacy of anti-Siglec-6 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.

Detailed Description

Sialic acid-binding immunoglobulin-like lectins (Siglec) are a class of classical immunoglobulin-like lectins. Studies have shown that Siglec-6 is commonly expressed in AML but not detected on normal hematopoietic stem and progenitor cells (HSC/P). In vitro experiments revealed that anti-Siglec-6 CAR-T cell treatment did not affect the viability or lineage differentiation in colony-forming assays. These data suggest that anti-SigLlec-6 is an ideal target with great potential for treating acute myeloid leukemia.

Conditions

Acute Myeloid Leukemia Refractory; Acute Myeloid Leukemia, in Relapse

Study Design

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

Study Groups

anti-siglec-6 CAR-T cell therapy

anti-siglec-6 CAR-T cell therapy

Group Type: EXPERIMENTAL

anti-siglec-6 CAR-T cell therapy

Intervention Type: DRUG

Enrolled patients will receive prespecified dose of autologous CAR-T cells.

Interventions

anti-siglec-6 CAR-T cell therapy

Enrolled patients will receive prespecified dose of autologous CAR-T cells.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. At the age of 18-70 years old;

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

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 is positive; HCV 、HIV or 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: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kai Lin Xu，MD

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kailin Xu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Xuzhou Medical University

Locations

Kailin Xu

Xuzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kailin Xu, M.D., Ph.D.

Role: CONTACT

lihmd@163.com

15162166166

Facility Contacts

Kailin Xu, M.D., Ph.D.

Role: primary

86-516-85802007

Other Identifiers

XYFY2022-KL119-01

Identifier Type: -

Identifier Source: org_study_id