Acute Myeloid LeukemiaPhase 1NCT07661095
A Study of CRD3874-SI in People With Leukemia
A Phase 1 study testing CRD3874-SI in people with Acute Myeloid Leukemia and AML, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The purpose of this study is to find out whether CRD3874-SI is a safe treatment for participants with acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, AML, Refractory Acute Myeloid Leukemia
- What is being tested?
- CRD3874-SI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Jun 2026to 15 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 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]:
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- 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.
Who cannot join
- 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.
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- 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.
- (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:
- 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
- (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.
- Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment).
- Participant with active use of strong or moderate CYP3A4 inhibitors.
- Female participant who is pregnant or lactating.
- Because STING agonist agents impact immune and cellular functioning posing potential risk for impacting normal embryonic development, and because other therapeutic agents used in this trial are known to be teratogenic, participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 months (females) or 3 months (males) following the completion of study therapy. Male or female participants not willing to comply with contraceptive requirements will be excluded, which adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 months (females) or 3 months (males) following the completion of study therapy
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Eytan Stein, MD, 646-608-3749
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
Commack, New York, 11725
Eytan Stein, MD, 646-608-3749
- Recruiting
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604
Eytan Stein, MD, 646-608-3749
- Recruiting
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748
Eytan Stein, MD, 646-608-3749
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Eytan Stein, MD, 646-608-3749
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Eytan Stein, MD, 646-608-3749
Aaron Goldberg, MD, Phd, 646-608-3752
- Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, 11553
Eytan Stein, MD, 646-608-3749
About this study
Official title: A Phase 1 Study of the STING Agonist CRD3874-SI for Relapsed and Refractory Acute Myeloid Leukemia
The purpose of this study is to find out whether CRD3874-SI is a safe treatment for participants with acute myeloid leukemia (AML).
- Being tested
- CRD3874-SI
- Keywords
- Acute Myeloid Leukemia, AML, Refractory Acute Myeloid Leukemia, CRD3874-SI, Memorial Sloan Kettering Cancer Center, 26-144
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRD3874-SIDrug
CRD3874-SI is a STING (Stimulator of Interferon Genes) agonist in participants with relapsed and refractory (R/R) acute myeloid leukemia (AML).
| Study group | Role | What they receive |
|---|---|---|
| 0.6 mg/kg CRD3874-SI | Experimental | Not described Receives: Drug: CRD3874-SI |
| 0.9 mg/kg CRD3874-SI | Experimental | Not described Receives: Drug: CRD3874-SI |
| 1.4 mg/kg CRD3874-SI | Experimental | Not described Receives: Drug: CRD3874-SI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start15 Jun 2026
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eytan Stein, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661095
- Sponsor's protocol ID
- 26-144
- Status last verified
- Sep 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the STING Agonist CRD3874-SI for Relapsed and Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07661095
- Acronym / sponsor ID
- 26-144
- Keywords
- Acute Myeloid Leukemia, AML, Refractory Acute Myeloid Leukemia, CRD3874-SI, Memorial Sloan Kettering Cancer Center, 26-144
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether CRD3874-SI is a safe treatment for participants with acute myeloid leukemia (AML).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRD3874-SICRD3874-SI is a STING (Stimulator of Interferon Genes) agonist in participants with relapsed and refractory (R/R) acute myeloid leukemia (AML). | Drug | 0.6 mg/kg CRD3874-SI, 0.9 mg/kg CRD3874-SI, 1.4 mg/kg CRD3874-SI |
Primary outcome
Maximum tolerated dose of CRD3874-SI
Time frame: up to 1 year
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eytan Stein, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CRD3874-SI in people with Acute Myeloid Leukemia and AML, run by Memorial Sloan Kettering Cancer Center at 7 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 14 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eytan Stein, MD (646-608-3749, SteinE@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of CRD3874-SI (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.