NCT04310592

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

A Phase I Multi-dose Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) with or Without Recombinant Human Interleukin-2 (rhIL-2) in Adults with Primary or Secondary Acute Myeloid Leukemia (AML) in Morphologic Complete Remission with Minimal Residual Disease (MRD) or Relapsed/refractory (R/R) AML

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Celularity Incorporated · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Neoplasms by Histologic Type
• Neoplasms
• Immunosuppressive Agents
• Immunologic Factors
• Physiological Effects of Drugs
• Alkylating Agents
• Antimetabolites, Antineoplastic
• Antiviral Agents
• Analgesics, Non-narcotic
• Anti-infective Agents
• Analgesics
• Peripheral Nervous System Agents
• Hematologic Diseases
• Hematologic Neoplasms
• Leukemia in Remission
• Relapsed Adult AML
• Refractory AML

Interventions

Type	Name	Description
BIOLOGICAL	CYNK-001	CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.

Timeline

• Start date: 2020-03-12
• Primary completion: 2023-01-20
• Completion: 2023-04-28
• First posted: 2020-03-17
• Last updated: 2024-12-12

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study