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Acute Myeloid LeukemiaPhase 1NCT04937166

A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies

A Phase 1 study testing DSP107, Azacitidine and Venetoclax in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Kahr Medical at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will be divided into two parts, Parts A and B and will enroll patients with relapsed/refractory AML or MDS/chronic myelomonocytic leukemia (CMML) patients who have failed up to 2 prior therapeutic regimens. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DSP107, Azacitidine and Venetoclax
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesUnited States
Study dates
13 Jan 2022to 24 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • City of Hope

    Duarte, California, 91010

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

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: An Open-label Phase Ib Study of DSP107 for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

This study will be divided into two parts, Parts A and B and will enroll patients with relapsed/refractory AML or MDS/chronic myelomonocytic leukemia (CMML) patients who have failed up to 2 prior therapeutic regimens.

Part A is a dose escalation study to explore the safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) profile of DSP107 when administered in combination with azacitidine (AZA).

Part B is a dose escalation study to explore the safety, efficacy, PK and PD profile of DSP107 when administered in combination with AZA and venetoclax (VEN).

Read the detailed description

Part A is a dose escalation study in up to 4 cohorts of patients designed to test the safety and efficacy of DSP107 administered alone and in combination with AZA. The DSP107 starting dose level in Part A will be 0.3 mg/kg based on aggregate safety, PK and PD data from study DSP107_001, an ongoing study exploring the safety of escalating DSP107 doses in patients with advanced solid tumors. There will be a single DLT evaluation period, lasting 28 days, to determine the safety of DSP107 in combination with AZA. The safety, efficacy and PK data will be used to establish a recommended Phase II dose for potential future expansion cohorts and a starting dose for Part B.

Part B is a dose escalation study in 2 cohorts of patients that will test the safety and efficacy of DSP107 in combination with AZA and VEN. The starting dose for Part B will be at least one dose level lower than the DSP107 dose selected in Part A as being safe and effective in combination with AZA. Once a safe, effective dose has been established in Part B, a recommended phase 2 dose for patients with newly diagnosed AML will be agreed with the FDA at an End-of-Phase 1 meeting.

Being tested
DSP107, Azacitidine, Venetoclax
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DSP107Biological

    DSP107 (SIRPα - 4-1BBL) is a bi-functional, trimeric, fusion protein.

  • AzacitidineDrug

    Also called Vidaza

    Azacitidine is an analog of the pyrimidine nucleoside cytidine.

  • VenetoclaxDrug

    Also called Venclexta, Venclyxto

    Venetoclax is a B-cell lymphoma (BCL)-2 inhibitor

Study groups in NCT04937166
Study groupRoleWhat they receive
DSP107 in combination with azacitidine or azacitidine plus venetoclax.ExperimentalDSP107 will be administered by intravenous infusion once weekly during each 28-day cycle to all patients in this study. Azacitidine (75 mg/m2/day) will be administered subcutaneously or intravenously for the first 7 days of every cycle. Patients enrolled in Part B only will also receive venetoclax. During Cycle 1, venetoclax will be dose escalated daily to the goal dose of 400 mg daily. Patients will receive 100 mg on Day 1, 200 mg on Day 2 and 400 mg on Day 3 and onwards.
Receives: Biological: DSP107; Drug: Azacitidine; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events (AEs)

    An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

    Measured: Duration of the study, estimated to be 12 months

  2. Dose Limiting Toxicities (DLT)

    A DLT is defined as a clinically significant AE or laboratory abnormality that is related to DSP107 or the combination of DSP107 and AZA, but is unrelated to disease progression, intercurrent illness or concomitant medications

    Measured: At the end of Treatment Cycle 2 (within 2 months of treatment initiation)

  3. Response Rate (RR) including Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi)

    Response rates will be determined by assessing peripheral blood and bone marrow samples.

    Measured: Within 6 months of treatment initiation

Secondary outcomes (7)

  1. Overall Response Rate (ORR)

    Peripheral and bone marrow samples will be assessed to determine ORR. The ORR will measure the proportion of patients who achieve CR, CRi, complete remission with incomplete hematological recovery (CRh), complete remission with incomplete platelet recovery (CRp) or partial response (PR) within 6 months of treatment initiation, with or without cytogenetic response, hematological improvements and a morphologic leukemia-free state.

    Measured: Within 6 months of treatment initiation

  2. Morphologic Leukemia-Free (MLF) Rate

    Peripheral and bone marrow samples will be assessed to determine the proportion of patients who are morphologically leukemia-free within 6 months of treatment initiation.

    Measured: Within 6 months of treatment initiation

  3. Minimal Residual Disease (MRD) Status

    Peripheral and bone marrow samples will be assessed to determine minimal residual disease (MRD) status at response and/or the best MRD response during study participation.

    Measured: Duration of the study, estimated to be 12 months

  4. 4-week Mortality Rate

    The proportion of patients who die within 4 weeks of treatment initiation.

    Measured: Within 4 weeks of treatment initiation

  5. DSP107 Serum Concentration

    Serum samples will be collected to determine circulating levels of DSP107.

    Measured: Duration of the study, estimated to be 12 months

  6. DSP107 anti-drug antibody (ADA) formation

    Serum samples will be collected throughout the study for assessment of ADA formation using validated assay.

    Measured: Duration of the study, estimated to be 12 months

  7. Change in Phenotypic and Activation Profiles of Peripheral Blood Mononuclear Cells

    Whole blood samples will be collected throughout the study for immunophenotyping by flow cytometry and/or mass cytometry.

    Measured: Duration of the study, estimated to be 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2021
  2. Study start13 Jan 2022
  3. Primary completion23 Apr 2025
  4. Study completion24 Oct 2025

Why it stopped: Slow enrolment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
This study will involve sequential enrollment of approximately 36 patients accrued into six dose cohorts, each testing a different DSP107 dose level in combination with azacitidine (Part A) or DSP107 in combination with azacitidine and venetoclax (Part B).
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04937166
Sponsor's protocol ID
DSP107_002
Status last verified
Nov 2025
First submitted
6 Jun 2021
Last updated
10 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DSP107, Azacitidine and Venetoclax in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Kahr Medical at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slow enrolment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: Duration of the study, estimated to be 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04937166.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.

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