Testing an Anti-cancer Radio-Active Immunotherapy Called Lintuzumab Ac225 in Patients With High-R… (NCT06888323) | Clinical Trial Compass
SuspendedPhase 1
Testing an Anti-cancer Radio-Active Immunotherapy Called Lintuzumab Ac225 in Patients With High-Risk Myelodysplastic Syndrome That Has Not Responded to Other Treatment
Stopped: Drug Supply Issues
United States18 participantsStarted 2026-09-03
Plain-language summary
This phase I trial tests the safety, side effects and best dose of lintuzumab-Ac225 for the treatment of patients with high risk myelodysplastic syndrome that has not responded to previous treatment (refractory). Lintuzumab-Ac225 is a monoclonal antibody, called lintuzumab, linked to a radioactive agent called Ac225. Lintuzumab attaches to CD33 positive cancer cells in a targeted way and delivers Ac225 to kill them. Giving lintuzumab-Ac225 may be safe, tolerable and/or effective in treating patients with high risk, refractory myelodysplastic syndrome.
Who can participate
Age range
18 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:
* Patients must have histologically or cytologically confirmed diagnosis of MDS by bone marrow biopsy by World Health Organization (2016) guidelines
* Patients with MDS who have progressed or had no response after 6 cycles of azacitidine or 4 cycles of decitabine
* Patients with MDS must have ≥ 5% myeloblasts
* Patients with demonstration of CD33 positive myeloblasts more than 25% on flow cytometry
* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of lintuzumab-Ac225 in patients \< 18 years of age, children are excluded from this study
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
* Serum direct bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × institutional ULN
* Creatinine clearance ≥ 60 mL/min (creatinine clearance \[CrCl\] will be calculated using actual body weight unless the patient is obese \[body mass index (BMI) ≥ 30 kg/m²\], in which case adjusted body weight will be used)
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepati…
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
Maximum tolerated dose
Timeframe: Up to 70 days from first dose of lintuzumab-ac225