Natural Killer Cell (CYNK-001) Infusions in Adults With Multiple Myeloma

Phase 1

Active, not recruiting

• Conditions: Multiple Myeloma; Hemostatic Disorder; Cardiovascular Diseases; Hematologic Diseases; Lymphoproliferative Disorders; Physiological Effects of Drugs; Neoplasm, Plasma Cell; Neoplasms; Paraproteinemias; Blood Protein Disorders
• Interventions: Biological: CYNK-001

• Registration Number: NCT04309084
• Lead Sponsor: Celularity Incorporated

Brief Summary

This study will find the maximum tolerated dose (MTD) of CYNK-001 which contain NK cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given post Autologous Stem Cell Transplant (ASCT). The safety of this treatment will be evaluated, and researchers will want to learn if NK cells will help in treating Multiple Myeloma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-13
• Study First Posted: 2020-03-16
• Study Start: 2020-05-12
• Primary Completion: 2023-01-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase I	CYNK-001	Up to three dosing cohorts of CYNK-001 given on Day 2 or Days 2, 7, 14 post ASCT. Once MTD has been determined, the Expansion cohort will commence.

Primary Outcome Measures

Name	Time	Method
Dose-Limiting Toxicity (DLT)	Up to 28 days	Safety Assessment of Dose-Limiting Toxicity (DLT)
Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD)	Up to 28 days	Safety Assessment of MTD OR MPD
Rate of Minimal Residual Disease (MRD) Negativity	Day 90-100	Efficacy Assessment of MRD
Adverse Events (AE)	Up to 12 months	Safety Assessment of AE's

Secondary Outcome Measures

Name	Time	Method
International Myeloma Working Group (IMWG) response	up to 12 months	Efficacy Assessment of response
Progression-free survival	up to 12 months	Efficacy Assessment of response
time to progression	up to 12 months	Efficacy Assessment of response
overall survival	up to 12 months	Efficacy Assessment of response
Quality of life questionnaire	up to 12 months	Efficacy Assessment of response
Minimal Residual Disease (MRD) Response	Day 90-100	Efficacy Assessment of MRD
Time to MRD Response	up to 12 months	Efficacy Assessment of MRD
duration of clinical response	up to 12 months	Efficacy Assessment of response

Trial Locations

Locations (4)

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

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

Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States