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New targeted radiation therapy tested for stubborn bone marrow cancer

NCT ID NCT06888323

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This early-phase trial tests a drug called lintuzumab-Ac225 in 18 adults with high-risk myelodysplastic syndrome (MDS) that did not improve after standard treatment. The drug is an antibody that seeks out cancer cells and delivers a radioactive payload to kill them. The main goal is to find a safe dose and check for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lintuzumab-Ac225 (a monoclonal antibody linked to a radioactive particle)
What this could lead to
If it works, this could point toward a new treatment option for people with high-risk MDS that hasn't responded to standard therapy.
What could go wrong
This is a very early, small Phase 1 trial (18 people) focused on safety and dosing, not proof of effectiveness. The study is currently suspended, and the radioactive agent may cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better * The effects of lintuzumab-Ac225 on the developing human fetus are unknown. For this reason and because CD33 radiotherapy agents are known to be teratogenic, female patients of childbearing age must have had a negative serum pregnancy test within 14 days of initiation of dosing and must agree to use of two acceptable methods of birth control while on the study drug. A woman must agree to remain on a highly effective method throughout the study and for at least 6 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. During the study and for 3 months after receiving the last dose of study drug, men participating in this trial must use highly effective contraception. Men who are sexually active with a woman of childbearing potential must use a barrier method of contraception, such as a condom, in addition to ensuring use of a highly effective method of contraception. Men who are sexually active with a woman who is pregnant must use a condom. Male participants must also agree not to father a child or donate sperm during the study and for 3 months after receiving the last dose of study drug * Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants Exclusion Criteria: * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients have active clinically significant graft vs. host disease (GVHD) or are on systemic corticosteroids * Patients have clinically active central nervous system (CNS) leukemia * Patients who are receiving any other investigational agents, such as experimental treatment in a clinical trial within the last 14 days or 5 half-lives, whichever is longer, prior to enrollment, or is currently enrolled in any other type of medical research (e.g. medical device) not scientifically or medically compatible with this study * Patients who are receiving any therapy that can result in increased toxicity on this study or confound the study findings, within the last 14 days or 5 half-lives, whichever is longer, prior to enrollment. Non-hematological adverse reactions to prior therapies, except alopecia and peripheral neuropathy, must have resolved to no more than grade 1 * History of allergic reactions attributed to compounds of similar chemical or biologic composition to lintuzumab-Ac225 * Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous * Pregnant women are excluded from this study because lintuzumab-Ac225 is a CD33 radiotherapy agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lintuzumab-Ac225, breastfeeding should be discontinued if the mother is treated with lintuzumab-Ac225 * The patient had major surgery within 14 days prior to enrollment * No prior radiopharmaceutical therapy and no radiation therapy within the last 120 days prior to cycle 1 day 1 (C1D1), as this may contribute to added toxicity * Patients who are unable to take spironolactone or eplerenone due to intolerance, allergy, drug-drug interactions, or for any other reason

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Conditions

The condition(s) this trial relates to.

myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dana-Farber - Harvard Cancer Center LAO

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.