A Study of CRD3874-SI in People With Leukemia

NCT07661095 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 26-144
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to find out whether CRD3874-SI is a safe treatment for participants with acute myeloid leukemia (AML).

Conditions

Acute Myeloid Leukemia; AML; Refractory Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; AML; Refractory Acute Myeloid Leukemia; CRD3874-SI; Memorial Sloan Kettering Cancer Center; 26-144

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of CRD3874-SI

  To assess the safety and tolerability and RP2D of CRD3874 in R/R AML by determining the maximum tolerated dose (MTD) and recommended phase 2 dose (R2PD)

  up to 1 year

Study Arms (3)

0.6 mg/kg CRD3874-SI

EXPERIMENTAL

Drug: CRD3874-SI

0.9 mg/kg CRD3874-SI

EXPERIMENTAL

Drug: CRD3874-SI

1.4 mg/kg CRD3874-SI

EXPERIMENTAL

Drug: CRD3874-SI

Interventions

CRD3874-SI DRUG

CRD3874-SI is a STING (Stimulator of Interferon Genes) agonist in participants with relapsed and refractory (R/R) acute myeloid leukemia (AML).

0.6 mg/kg CRD3874-SI; 0.9 mg/kg CRD3874-SI; 1.4 mg/kg CRD3874-SI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documentation of Disease
• o Participant has relapsed or refractory acute myeloid leukemia, defined as bone marrow blasts ≥ 5%, and/or reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart, and/or development of extramedullary disease; or, no CR, CRh or CRi at response assessment after at least 1 line of therapy, as defined by standardized European LeukemiaNet 2022 Criteria. Patients must have failed treatment with available therapies known to be active for treatment of their AML.
• Participant must be ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Participant must weigh at least 40 kg
• Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 (See Appendix I for performance status criteria)
• For patients with known HIV, HBV, and/or HCV infection \[HIV, HBV, and HCV testing do not need to be performed as part of the study; the below language provides guidelines for inclusivity of patients with known HIV, HBV, and/or HCV infection\]:
• 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.
• Required Organ Function
• Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.
• Serum total bilirubin \< 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome.
• Calculated creatinine clearance (CrCl) ≥ 60 mL/min by Cockcroft-Gault formula or CKD-EPI 2021 or estimated glomerular filtration rate 60 mL/min or greater based on local institutional practice for age-appropriate determination (e.g, Schwartz formula for pediatric patients or Cockcroft Gault formula for adults).
• Adequate cardiac function defined as ejection fraction of ≥ 50% by echocardiogram.

You may not qualify if:

• Participants with acute promyelocytic leukemia
• Participants with isolated myeloid sarcoma
• Blast phase of chronic myeloid leukemia
• Known active central nervous system leukemia
• Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation, or uncontrolled tumor lysis syndrome.
• Participant has presence of any other condition that may increase the risk associated with study participation, and in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.
• Participants with concurrent other malignancy that will confound interpretation of study endpoints.
• Participants who have received other anti-leukemia therapy within 5 half-lives of the agent or 14 days, whichever is sooner, prior to study treatment and if toxicity related to said agent has not resolved; exceptions of acceptable concomitant therapies are listed below
• Concomitant cytoreductive therapy in the form of hydroxyurea, corticosteroids, or cytarabine is permitted.
• Concomitant therapy in the form of intrathecal chemotherapy for CNS treatment, is permitted.
• Radiation therapy is not permitted except for localized palliative radiation to focal lesions after discussion with the Medical Monitor for patients who have progressed but remain on the study due to perceived clinical benefit per Investigator assessment
• Known prior severe hypersensitivity to an investigational product or any component of the study drug therapy's formulations including polyethylene glycol (PEG; National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v6.0 Grade ≥ 3)
• Prior organ transplantation, other than allogeneic or autologous hematopoietic stem cell transplantation.
• Received a live vaccine within 30 days of the planned start of study drug.
• a. (Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed.)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Eytan Stein, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eytan Stein, MD

CONTACT

646-608-3749; SteinE@mskcc.org

Aaron Goldberg, MD, PhD

CONTACT

646-608-3752; goldbera@mskcc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (7)