Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)

NCT06125652 | Recruiting Phase 1

• 1 other identifier: XYFY2023-KL358-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of anti Tim3/CD123 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.

Conditions

Acute Myeloid Leukemia Refractory; Acute Myeloid Leukemia, in Relapse

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity #DLT#

  Adverse events assessed according to NCI-CTCAE v5.0

  Baseline up to 28 days after CAR-T cells infusion

Secondary Outcomes (4)

• MRD negative overall response rate (MRD- ORR)

  3 months

• Overall response rate (ORR)

  Month 6, 12, 18 and 24

• Event-free survival (EFS)

  Month 6, 12, 18 and 24

• Overall survival (OS)

  Month 6, 12, 18 and 24

Study Arms (1)

anti Tim-3/CD123 CAR-T cell therapy

EXPERIMENTAL

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

Drug: anti Tim-3/CD123 CAR-T cell therapy

Interventions

anti Tim-3/CD123 CAR-T cell therapy DRUG

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

anti Tim-3/CD123 CAR-T cell therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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;
• At the age of 18-70 years old;
• Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
• 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 is positive; HCV #HIV or 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

• Xuzhou Medical University: lead

Study Sites (1)

Kailin Xu

Xuzhou, Jiangsu, 221000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kailin Xu, MD.,PD.

  The Affiliated Hospital oh Xuzhou Medical University

  STUDY CHAIR

Central Study Contacts

Kailin Xu, MD.,PD.

CONTACT

15162166166; lihmd@163.com

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: President

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 9, 2023
• Study Start: November 4, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)