Study of IBR733 Cell Injection in Acute Myeloid Leukemia
ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-74
SponsorImbioray (Hangzhou) Biomedicine Co., Ltd.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
IBR733 Cell Injection
Biological/VaccineThe 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.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: IBR733 Cell InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of dose limiting toxicity (DLT)
To evaluate the safety, tolerability, and determine the RP2D of IBR733 cell injection
Time frame
From day1 to day 212
The incidence and severity of adverse events (AEs)
To evaluate the safety of IBR733 cell injection
Time frame
From day 1 to day 30 after the last doseSecondary outcomes
1
Complete remission rate (CRR)
The rate of subjects who achieved complete remission (CR) among all subjects
Time frame
From day 1 up to 6 weeks2
Composite complete remission rate
The rate of subjects achieving complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) or complete remission with partial hematologic recovery (CRh) among all subjects
Time frame
From day 1 up to 6 weeks3
Objective remission rate (ORR)
The rate of subjects achieving CR, CRi, morphologic leukemia-free state(MLFS), and partial remission(PR) among all subjects
Time frame
From day 1 up to 6 weeks4
Duration of remission (DOR)
Time from the subject's first assessment of the onset of remission to the first assessment of disease recurrence or progression or death from any cause
Time frame
From day 1 up to 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Imbioray (Hangzhou) Biomedicine Co., Ltd.
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborator
Source ClinicalTrials.gov