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NK Cell Therapy

CYNK001-IV for Glioblastoma (CYNK001GBM01 Trial)

Phase 1
Waitlist Available
Research Sponsored by Celularity Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1year
Awards & highlights

CYNK001GBM01 Trial Summary

This study is evaluating whether a type of white blood cell called natural killer cells may help treat recurrent glioblastoma multiforme.

Eligible Conditions
  • Glioblastoma
  • Cyclophosphamide
  • Immune Factors
  • Drug Effects
  • Molecular Pharmacology
  • Antiviral Agents
  • Antibiotics
  • Non-Narcotic Analgesics
  • Painkillers
  • Sensory System Agents
  • Peripheral Nervous System Agents
  • Immunosuppressants

CYNK001GBM01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events (AEs)
Number of Participants who experienced a Dose-Limiting Toxicity (DLT)
Secondary outcome measures
Duration of Response Rate
Overall Response Rate
Overall Survival
+2 more

CYNK001GBM01 Trial Design

2Treatment groups
Experimental Treatment
Group I: Intravenous IV ( Recurrent and Surgical ) GBMExperimental Treatment1 Intervention
Cohort 1A ( recurrent GBM) will receive CYNK-001 at a dose of 1.2 x 10^9 cells intravenous ( IV) on Days 0, 7, and 14 and will include up to 6 subjects. The subjects will be followed for a 42 day DLT period from the initial CYNK-001 infusion (or 28 days after the last dose). No other treatment interventions are planned between the last day of CYNK-001. In the event of DLTs, Cohort 1C ( recurrent GBM dose-De escalation) will receive CYNK-001 at a dose of 600 x 10^6 cells (IV) on Days 0, 7, 14, and will include up to 6 subjects who will be followed for a 42-day DLT period from the initial CYNK-001 infusion (or 28 days after the last dose. Cohort 1B (surgical cohort) will receive CYNK-001 at the maximum safe dose (MSD) (either 1.2x10^9 cells or 600x10^6 cells) (IV) at Days 0, 7, 14, and will include up to 6 subjects. The tumor resection surgery will be performed after the last CYNK-001 infusion during the DLT period.
Group II: Intratumoral IT ( Recurrent and Surgical ) GBM)Experimental Treatment1 Intervention
The cohort 2A or cohort 2C (recurrent GBM) IT route of administration can be started only after the safety results were acceptable from the completion of cohort 1A or Cohort 1C (IV route of administration). The Treatment Period for the IT cohorts will begin with having the Ommaya catheter placement per institutional policy, which is planned to occur within one week prior to the CYNK-001 administration on Day 0. Cohort 2A will be treated with CYNK-001 IT at 200 x 10^6 ± 50 x 10^6 cells IT on Day 0, 7 and 14 includes up to 6 recurrent GBM subjects Cohort 2C ( dose de-escalation) will be treated with CYNK-001 200 x 106 ± 50 x 106 cells IT on Day 0, and Day 7 ( only two days dosing) and include up to 6 recurrent GBM subjects. Cohort 2B ( the surgical IT cohort) will be treated with CYNK-001 at the maximum safe dose ( MSD) (either 200 x 10^6 ± 50 x 10^6 cells on Days 0, 7 and 14 or at 200 x 10^6 ±50x10^6 cells on Days 0 and 7) and include up to 6 surgical GBM subjects

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Who is running the clinical trial?

Celularity IncorporatedLead Sponsor
16 Previous Clinical Trials
624 Total Patients Enrolled
1 Trials studying Glioblastoma
Mark Awadalla, BSStudy DirectorCelularity inc.
Sharmila Koppisetti, MDStudy DirectorCelularity inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM
2020. "Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04489420.
~1 spots leftby May 2025
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