A Study of CRD3874-SI in People With Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to find out whether CRD3874-SI is a safe treatment for participants with acute myeloid leukemia (AML).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documentation of Disease
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)
Disqualifiers
Participants with acute promyelocytic leukemia
Participants with isolated myeloid sarcoma
Blast phase of chronic myeloid leukemia
Known active central nervous system leukemia
Trial design
Design model
Sequential
Treatments tested in this trial
CRD3874-SI
DrugCRD3874-SI is a STING (Stimulator of Interferon Genes) agonist in participants with relapsed and refractory (R/R) acute myeloid leukemia (AML).
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: 0.6 mg/kg CRD3874-SIExperimental treatment 1 intervention
Group B: 0.9 mg/kg CRD3874-SIExperimental treatment 1 intervention
Group C: 1.4 mg/kg CRD3874-SIExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov