Study of IBR733 Cell Injection in Acute Myeloid Leukemia (NCT06234904) | Clinical Trial Compass
RecruitingPhase 1
Study of IBR733 Cell Injection in Acute Myeloid Leukemia
China18 participantsStarted 2024-03-26
Plain-language 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).
Who can participate
Age range
18 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of dose limiting toxicity (DLT)
Timeframe: From day1 to day 21
2
The incidence and severity of adverse events (AEs)
Timeframe: From day 1 to day 30 after the last dose
. 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.
Exclusion criteria
. 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..
. Subjects who have had other malignant tumors within 3 years before inclusion, except for any type of carcinoma in situ that has been cured in the past and cured skin basal cell carcinoma or skin squamous cell carcinoma.