Natural Killer Cell (CYNK-001) Infusions in Adults with AML

Phase 1

Terminated

• Conditions: Leukemia in Remission; Relapsed Adult AML; Neoplasms; Immunosuppressive Agents; Analgesics, Non-narcotic; Anti-infective Agents; Analgesics; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Immunologic Factors
• Interventions: Biological: CYNK-001

• Registration Number: NCT04310592
• Lead Sponsor: Celularity Incorporated

Brief Summary

This study will find the maximum tolerated dose or the maximum planned dose of CYNK-001 which contains natural killer (NK) cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given after lymphodepleting chemotherapy. The safety of this treatment will be evaluated, and researchers want to learn if NK cells will help in treating acute myeloid leukemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-12
• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-13
• Study First Posted: 2020-03-17
• Primary Completion: 2023-01-20
• Status Verified: 2023-03
• Study Completion: 2023-04-28
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose escalation/MTD or MPD determination in Relapsed/Refractory AML patients	CYNK-001	Cyclophosphamide + Fludarabine prior to CYNK-001 on Days 0, 7, and 14; CYNK-001 at 3 varying dose levels.
Dose escalation/MTD or MPD determination in MRD positive AML patients	CYNK-001	Cyclophosphamide + Fludarabine prior to CYNK-001 on Days 0, 7, and 14; CYNK-001 at 3 varying dose levels.

Primary Outcome Measures

Name	Time	Method
Number of Participants who experience a Dose-limiting Toxicity (DLT) in Relapsed/Refractory AML patients	Day +28	The number of participants who experience a DLT will be measured.
Number of Participants who experience a Dose-limiting Toxicity (DLT) in MRD positive AML patients	Day +28	The number of participants who experience a DLT will be measured.
Determine the Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD) of CYNK-001 in MRD positive AML patients	up to 28 days	The maximum dose safely administered for the treatment of patients with AML.
Determine the Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD) of CYNK-001 in Relapsed/Refractory AML patients	up to 28 days	The maximum dose safely administered for the treatment of patients with AML.
Frequency and Severity of Adverse Events (AEs)	up to 12 months	Frequency and severity of Adverse Events will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	up to 12 months	Date of first CYNK-001 infusion to date of death.
Duration of Morphologic Complete Remission (CR)	up to 12 months	Duration from first Morphologic CR observation to time of disease progression in the MRD positive arm.
Duration of MRD Response	up to 12 months	The measure of how long participants remain MRD negative in the MRD positive arm.
Time to MRD Response	up to 12 months	The time it takes to convert from MRD positive to MRD negative in the MRD positive arm.
Progression-free Survival (PFS)	up to 12 months	Date of first CYNK-001 infusion to date of disease progression in the MRD positive arm.
Number Participants who experience Minimal Residual Disease (MRD) Response	up to 12 months	The number of participants who convert from MRD positive to MRD negative in the MRD positive arm.
Time to Progression (TTP)	up to 12 months	Date of first CYNK-001 infusion to date of disease progression in the MRD positive arm.
Overall Response Rate (ORR)	up to 12 months	Defined as achievement of Complete Remission (CR), Complete Remission with incomplete (CRi) hematologic recovery, or Morphologic leukemic-free state (MLFS) in the Relapsed/Refractory AML arm.
Duration of Response (DoR)	up to 12 months	Duration of best response in the Relapsed/Refractory AML arm.

Trial Locations

Locations (10)

Colorado Blood Cancer Institute; 🇺🇸 Denver, Colorado, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Roswell Park Comprehensive Cancer Center; 🇺🇸 Buffalo, New York, United States

Columbia University and New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Westchester Medical Center; 🇺🇸 Valhalla, New York, United States

Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Swedish Health Services; 🇺🇸 Seattle, Washington, United States