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Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM

NCT04489420 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-08-10

No results posted yet for this study

Summary

This study will find the maximum safe dose (MSD) or maximum tolerated dose (MTD) of CYNK-001 which are NK cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given after lymphodepleting chemotherapy for the systemic cohort (IV) (intravenous). The intratumoral cohort (IT) will not be giving lymphodepletion. The safety of this treatment will be evaluated, and researchers want to learn if NK cells will help in treating recurrent glioblastoma multiforme.

Conditions

  • Astrocytoma, Grade IV
  • Giant Cell Glioblastoma
  • Glioblastoma Multiforme
  • Cyclophosphamide
  • Immunosuppressive Agents
  • Immunologic Factors
  • Physiological Effects of Drugs
  • Molecular Mechanisms of Pharmacological Action
  • Antiviral Agents
  • Anti-infective Agents
  • Analgesics, Non-narcotic
  • Analgesics
  • Sensory System Agents
  • Peripheral Nervous System Agents

Interventions

BIOLOGICAL

CYNK001-IV

Planned Starting dose dor IV 1.2x10\^9 cells/dose

BIOLOGICAL

CYNK001-IT

Planned starting dose for IT 200 x10\^6 +/- 50 x10\^6 cells dose

Sponsors & Collaborators

  • Celularity Incorporated

    lead INDUSTRY

Principal Investigators

  • Sharmila Koppisetti, MD · Celularity inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-08-10
Completion
2021-08-10
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 NCT04489420 on ClinicalTrials.gov