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

NCT04310592 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-12-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Celularity Incorporated

    lead INDUSTRY

Principal Investigators

  • Sharmila Koppisetti, M.D · Celularity, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-12
Primary Completion
2023-01-20
Completion
2023-04-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04310592 on ClinicalTrials.gov