Study of IBR733 Cell Injection in Acute Myeloid Leukemia

NCT06234904 | Unknown Phase 1

• 1 other identifier: IBR733-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label clinical study: phase Ia is the dose-escalation part, and phase Ib is the dose-expansion part. The phase Ia study is to evaluate the safety, tolerability, recommended phase II dose, pharmacokinetics, immunogenicity and preliminary efficacy of IBR733 cell injection in relapsed/refractory acute myeloid leukemia (AML).

Conditions

Acute Myeloid Leukemia

Keywords

AML; R/R AML

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicity (DLT)

  To evaluate the safety, tolerability, and determine the RP2D of IBR733 cell injection

  From day1 to day 21

• The incidence and severity of adverse events (AEs)

  To evaluate the safety of IBR733 cell injection

  From day 1 to day 30 after the last dose

Secondary Outcomes (7)

• Complete remission rate (CRR)

  From day 1 up to 6 weeks

• Composite complete remission rate

  From day 1 up to 6 weeks

• Objective remission rate (ORR)

  From day 1 up to 6 weeks

• Duration of remission (DOR)

  From day 1 up to 3 months

• Overall survival (OS)

  From day 1 up to 3 months

Study Arms (1)

IBR733 Cell Injection

EXPERIMENTAL

Biological: IBR733 Cell Injection

Interventions

IBR733 Cell Injection BIOLOGICAL

The minimum initial dose is 5.0×10\^9 cells and then escalate to 7.5×10\^9 cells and 10.0×10\^9 cells. Every 21 days is one cycle, and intravenous infusion is performed on day 1 and day 8 of each cycle.

IBR733 Cell Injection

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects volunteer to participate in this clinical study, are fully aware of the study and have signed the Informed Consent Form (ICF). Subjects are willing to follow and able to complete all trial procedures.
• Age: 18-74 (both inclusive), female or male.
• Patients with AML (including secondary AML) diagnosed according to the WHO 2022 criteria.
• Patients with AML who meet one of the following criteria: (1) Relapsed AML: reoccurrence of leukemia cells in peripheral blood or ≥5% blasts in bone marrow after complete remission (excluding other causes such as bone marrow regrowth after consolidation chemotherapy); (2) Refractory AML: treatment-naive patients who failed to respond to 2 courses of standard treatment; The patients relapsed within 12 months after consolidated intensive treatment; Patients who relapsed after 12 months but failed to respond to conventional chemotherapy (only once); Patients who are relapsed twice; (3) Patients received up to 3 additional cycles of chemotherapy or targeted therapy after the diagnosis of relapsed/refractory AML.
• Eastern Cooperative Oncology Group (ECOG) score ≤2.
• Subjects of reproductive age and their partners should agree to have no family planning and to use effective contraceptive methods for 6 months from signing the ICF until the last dose of the study drug is administered.
• Expected survival time ≥3 months.

You may not qualify if:

• Acute promyelocytic leukemia.
• Chronic myeloid leukemia with myeloid blast crisis.
• Clinically symptomatic central nervous system involvement (no need for lumbar puncture).
• Subjects who have undergone an allogeneic hematopoietic stem cell transplantation or other organ transplantation.
• Subjects who have undergone autologous hematopoietic stem cell transplantation less than 3 months before the first dose of treatment.
• Subjects who have received cell immunotherapy such as chimeric antigen receptor-modified T cells (CAR-T), chimeric antigen receptor-natural killer cells (CAR-NK), and T cell receptor gene-modified T cells (TCR-T).
• Subjects who have received systemic antitumor therapy (except hydroxyurea) within 2 weeks before the first dose of study drug, including chemotherapy, immunotherapy, etc..
• The absolute peripheral blood blast count (ABC) \> 40.0×10\^9/L (ABC= total white blood cell count × blast %). The total white blood cell count can be controlled with hydroxyurea, but it must be stopped three days before the first dose of study drug or lymphodepletion.
• Organ function: (1) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\>3 times upper limit of normal (ULN); If AST was elevated due to leukemia but liver function was normal (e.g., normal ALT, alkaline phosphatase, and direct/indirect bilirubin measurements), participants could be enrolled after investigator consent was obtained; (2) Serum total bilirubin \>2.5×ULN (not applicable to patients with Gilbert's syndrome); (3) Creatinine clearance \<45mL/min (estimated by Cockcroft-Gault formula) or creatinine \>2×ULN; (4) Activated partial thromboplastin time \>1.5×ULN or international normalized ratio \>1.5×ULN.
• Subjects whose cardiac function and disease meet one of the following conditions within 6 months before the first administration: (1) Any risk factors that increase QTcF (Fridericia formula) interval prolongation, such as uncorrectable hypokalemia, hereditary long QT syndrome, and use of drugs that prolong the QTcF interval; (2) New York Heart Association (NYHA) classification ≥Grade 3; (3) Unstable angina pectoris, and myocardial infarction; (4) Left ventricular ejection fraction \<50% in resting state; (5) Clinically significant pericardial effusion determined by echocardiography.
• Subjects who have a history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that require systemic immunosuppressive/systemic disease modulating drugs within 2 years before the first administration.
• Active hepatitis B (e.g., DNA copy number \> 1000 cps/mL if only hepatitis B surface antigen is positive), active hepatitis C virus infection (anti-hepatitis C antibody positive and HCV RNA positive), or human immunodeficiency virus antibody positive.
• Women who are pregnant or lactating.
• Subjects who have received major surgery (for the definition of major surgery, refer to the Level 3 and 4 surgeries specified in the Administrative Measures for the Clinical Application of Medical Technology) within 28 days before the first administration.
• Subjects who have a history of alcohol, drug use or drug abuse in the past year;

Sponsors & Collaborators

• Imbioray (Hangzhou) Biomedicine Co., Ltd.: lead
• The First Affiliated Hospital of Soochow University: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

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

• Depei Wu, MD, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Depei Wu, MD, PhD

CONTACT

67781856; wudepei@suda.edu.cn

Xiaowen Tang, MD, PhD

CONTACT

67781856; tangxiaowen@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: January 31, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

CN (1)