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Testing an Anti-cancer Radio-Active Immunotherapy Called Lintuzumab Ac225 in Patients With High-Risk Myelodysplastic Syndrome That Has Not Responded to Other Treatment

NCT06888323 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Refractory Myelodysplastic Syndrome

Interventions

RADIATION

Actinium Ac 225 Lintuzumab

Given IV

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Buccal Swab

Undergo buccal swab

PROCEDURE

Computed Tomography

Undergo SPECT/CT

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT/CT

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Talha Badar · Dana-Farber - Harvard Cancer Center LAO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-27
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06888323 on ClinicalTrials.gov