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Experimental combo for tough blood cancers hits early hurdle

NCT ID NCT04937166

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested a new drug called DSP107 combined with standard chemotherapy drugs (azacitidine and venetoclax) in 25 people with relapsed or hard-to-treat acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia. The study aimed to check safety and find the right dose, but it was terminated early. It is too soon to know if this approach will help patients.

What this could mean

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

Active substance
DSP107 (a fusion protein) combined with azacitidine and venetoclax
What this could lead to
If successful, this could point toward a new combination treatment for certain blood cancers that have not responded to prior therapy.
What could go wrong
This was a very early (Phase 1) trial that was terminated, so results are limited. The combination may cause significant side effects, and it is unclear if it will work better than existing options.

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

25 people

The number who actually took part.

Started

Jan 2022

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * White Blood Cell count \< 20 x 10\^9/L. * Adequate organ function * Relapsed/refractory AML or MDS/CMML patients who have failed up to 2 prior therapeutic regimens. Exclusion Criteria: * Acute Promyelocytic leukemia * Symptomatic central nervous system (CNS) leukemia or patients with poorly controlled CNS leukemia * Life-threatening (grade 4) immune-mediated adverse event related to prior immunotherapy * Immune-mediated adverse reaction that required discontinuation of prior immunotherapy * Past or current history of autoimmune disease or immune deficiency * History of severe interstitial lung disease or severe pneumonitis or active pneumonitis * Clinically significant and poorly compensated liver disease * Prior organ allografts (such as renal transplant) requiring active immunosuppression * Active graft versus host disease * Treatment with systemic immunostimulatory within 4 weeks prior to initiation of study treatment * Treatment with any CD47/SIRPα targeting agent or immune agonists * Known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product * Received live, attenuated vaccine within 4 weeks prior to first dose of study treatment * Active Hepatitis B or C infection * History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease * Pregnant or breast feeding or planning to become pregnant while enrolled in the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • The University of Texas MD Anderson Cancer Center, Department of Leukemia

    Houston, Texas, 77030, United States

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