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Cell Therapy

NK Cell Therapy for Acute Myeloid Leukemia (CYNK001AML01 Trial)

Phase 1

Recruiting

Research Sponsored by Celularity Incorporated

Eligibility Criteria Checklist

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

Must have

Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2

Patient is ≥ 18 and ≤ 80 years of age at the time of signing the Study informed consent form (ICF)

Must not have

Patient has bi-phenotypic acute leukemia

Patient has had a Bone Marrow transplant < 60 days prior to screening or plans to have a transplant within the 28 day period following the first CYNK-001 infusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of a new leukemia treatment that usesNK cells.

Who is the study for?

Adults aged 18-80 with acute myeloid leukemia (AML) who've had at least one treatment, are not pregnant or breastfeeding, and can use contraception. They should have treated central nervous system involvement if present, be minimally immunosuppressed, and have an ECOG performance status ≤2. Excluded are those with significant medical conditions that could affect study results or organ dysfunction.

What is being tested?

The trial is testing CYNK-001 infusions after chemotherapy to find the highest dose patients can tolerate without severe side effects. CYNK-001 consists of natural killer cells derived from placental CD34+ cells aimed at treating AML by enhancing the body's immune response against cancer cells.

What are the potential side effects?

Potential side effects may include reactions related to infusion such as fever or chills, fatigue, nausea, and possible increased risk of infections due to immune system suppression from lymphodepleting chemotherapy prior to receiving CYNK-001.

Eligibility Criteria

Inclusion Criteria

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

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I can perform daily activities with minimal assistance.

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I am between 18 and 80 years old.

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My latest bone marrow test shows minimal residual disease.

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My AML is in the first or second complete remission or almost in remission.

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I can stop taking immunosuppressive drugs for 3 days before my treatment, except for low-dose steroids.

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I have AML that developed from MDS and have had at least one treatment for it.

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My AML did not respond to at least 2 initial treatments.

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I have AML from previous cancer treatments and have had at least one treatment for it.

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My condition relapsed or is resistant after initial treatment, confirmed by a pathology report.

Exclusion Criteria

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

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I have been diagnosed with bi-phenotypic acute leukemia.

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I had a bone marrow transplant less than 60 days ago or plan to have one within 28 days after my first CYNK-001 infusion.

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I have been diagnosed with acute promyelocytic leukemia.

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I have severe asthma or another lung condition and am on long-term medication.

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My organs are not functioning properly.

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I do not have severe organ problems that would affect my treatment.

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I have an autoimmune disease but it's under control and I'm not on active treatment.

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I have new or worsening lung issues visible on an x-ray or CT scan within 2 weeks of starting CYNK-001 treatment.

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My heart's pumping ability is below 40%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Determine the Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD) of CYNK-001 in MRD positive AML patients

Determine the Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD) of CYNK-001 in Relapsed/Refractory AML patients

Frequency and Severity of Adverse Events (AEs)

+2 more

Secondary study objectives

Duration of MRD Response

Duration of Morphologic Complete Remission (CR)

Duration of Response (DoR)

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose escalation/MTD or MPD determination in Relapsed/Refractory AML patientsExperimental Treatment1 Intervention

Cyclophosphamide + Fludarabine prior to CYNK-001 on Days 0, 7, and 14; CYNK-001 at 3 varying dose levels.

Group II: Dose escalation/MTD or MPD determination in MRD positive AML patientsExperimental Treatment1 Intervention

Cyclophosphamide + Fludarabine prior to CYNK-001 on Days 0, 7, and 14; CYNK-001 at 3 varying dose levels.

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

Celularity IncorporatedLead Sponsor

16 Previous Clinical Trials

533 Total Patients Enrolled

Solveig Ericson, MD, PhDStudy DirectorCelularity, Inc.

Cherie Daly, MDStudy DirectorCelularity, Inc.

Media Library

CYNK-001 (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04310592 — Phase 1

$Solid Tumors Research Study Groups: Dose escalation/MTD or MPD determination in Relapsed/Refractory AML patients, Dose escalation/MTD or MPD determination in MRD positive AML patients$