A Study of CRD3874-SI in People With Leukemia

Recruiting now · Phase 1

Conditions studied: Acute Myeloid Leukemia, AML, Refractory Acute Myeloid Leukemia

In brief

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

Key facts

Study ID: NCT07661095
Run by: Memorial Sloan Kettering Cancer Center
People needed: 24
Starts: 2026-06-15
Expected to finish: 2028-06-15
Last updated by the study team: 2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
Participants with active graft versus host disease (GVHD) of grade 2 or higher requiring systemic treatment. Skin GVHD solely managed with topical corticosteroids would not be exclusionary.
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.)
Evidence of clinically significant immunosuppression including the following:
a. Primary immunodeficiency state such as SCID b. Concurrent opportunistic infection c. Receiving systemic immunosuppressive therapy (>2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within seven days prior to enrollment. In the setting of non-immune mediated indications for use, chronic/active low dose steroid use (equivalent to ≤ 10 mg/day prednisone) may be permitted at the discretion of the Principal Investigator i. (Note: Other steroid formulations or steroid use for other indications may be permitted and include: 1) Intranasal, inhaled, ocular, or topical steroids, or local steroid injection (e.g., intra-articular injection); 2) Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; 3) Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past two years prior to enrollment
a. (Note: Replacement therapy [e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency] is not considered a form of systemic treatment for autoimmune disease.)
Evidence of clinically significant interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis related to prior immunotherapy treatment
Participant has significant active cardiac disease within 6 months prior to start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and/or stroke.
Participant has QTc interval (i.e., Fridericia's correction [QTcF]) ≥ 470 ms. Patients with a QTcF over 470 ms due to a bundle branch block or a pacemaker may participate in the study with approval of the study principal investigator.
Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.

Where it is running

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown, New Jersey, United States (enrolling)
Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (enrolling)
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities) — Commack, New York, United States (enrolling)
Memorial Sloan Kettering Westchester (All protocol activities) — Harrison, New York, United States (enrolling)
Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)
Memorial Sloan Kettering Nassau (All Protocol Activities) — Rockville Centre, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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