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STING Activator

CRD3874 for AML

Phase 1

Recruiting

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

Pathologically confirmed diagnosis of AML by 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemias criteria

Must not have

Unstable or deteriorating cardiovascular disease

Active Hepatitis B or C, or HIV disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called CRD3874, which activates a protein called STING in the body. STING helps the immune system kill cancer cells by producing proteins called Type 1 interfer

Who is the study for?

This trial is for patients with relapsed or refractory Acute Myeloid Leukemia (AML) who have tried other treatments without success. Participants must meet specific health criteria to join, but these details are not provided here.

What is being tested?

The study tests CRD3874, a synthetic drug designed to activate the STING protein in the body's immune system, potentially helping it produce molecules that fight cancer cells and improve responses to other anti-cancer treatments.

What are the potential side effects?

Potential side effects of CRD3874 are not listed here, but generally activating the immune system can lead to inflammation, flu-like symptoms, fatigue, and possibly affect normal cells along with cancer cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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My diagnosis of AML is confirmed by the latest standards.

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I have stopped taking myeloid growth factors before starting the study treatment.

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My AML has returned or didn't respond to treatment, and no standard treatments are left.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart condition is getting worse.

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I do not have active Hepatitis B, C, or HIV.

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I currently have an infection that isn't under control.

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I do not have any severe illnesses like heart failure or mental health issues that would prevent me from following the trial requirements.

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I have a history of lung conditions like interstitial lung disease or pneumonitis.

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I have recently had other treatments or an organ transplant.

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I have recently received a live vaccine.

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I have an active autoimmune disease that needs treatment.

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I have active leukemia in my brain or spinal cord.

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I am currently on medication that weakens my immune system.

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I have been diagnosed with acute promyelocytic leukemia.

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My condition is in the blast phase of chronic myeloid leukemia.

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I am not currently receiving any cancer treatments like chemotherapy.

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I have a serious lung condition.

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I have active tuberculosis.

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I do not have another cancer that could affect this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and Tolerability by Western blot analysis

Safety and Tolerability by colony formation assays

Safety and Tolerability by multiplex cytokine profiling

+1 more

Secondary study objectives

Area under the plasma concentration versus time curve (AUC)

Peak Plasma Concentration (Cmax)

Pharmacodynamic (PD) effects of CRD3874-SI

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: STING agonist CRD3874-SI in patients with relapsed/refractory acute myeloid leukemiaExperimental Treatment1 Intervention

Drug Product: CRD3874 solution for injection (CRD3874-SI) Type of drug: Synthetic small molecule Formulation: Sterile solution of CRD3874 for injection Route of Administration: IV infusion over one hour Strength: 6 mg/mL Schedule: Cycle: once weekly infusion x 4 (Days 1, 8, 15 and 22) over 28-day for Cycles 1 and 2. For Cycle 3 and onward, weekly infusion x 3 (Days 1, 8 and 15), until they develop unacceptable toxicities or disease progression, or do not achieve at least a morphologic leukemia-free state response after 6 cycles.

0 / 20Eligibility criteria met