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CAR T-cell Therapy

CYNK-001 systemic and Intra cavity administration for Glioblastoma (CYNK001GBM02 Trial)

Phase 1 & 2

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 6, 9,12 , 18 and 24 months

Awards & highlights

CYNK001GBM02 Trial Summary

This trial is testing the safety and efficacy of CYNK-001, in combination with recombinant human interleukin-2, for the treatment of recurrent glioblastoma in adults. The study will be conducted in two phases, with the first phase focused on safety and feasibility, and the second phase focused on efficacy.

Eligible Conditions

Glioblastoma

CYNK001GBM02 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6, 9,12 , 18 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6, 9,12 , 18 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 9,12 , 18 and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I-Number of patients experience Dose limiting toxicity (DLT)

Phase IIa CYNK-001 efficacy

To establish maximum tolerated dose (MTD) and a Recommended Phase 2a Dose (RP2D)

Secondary outcome measures

Overall survival phase I and IIa

Phase 1-Progression free survival at 6 Months

Other outcome measures

Evaluation of Neurological Assessment of the Neuro Oncology Scale in Glioblastoma (NANO

Health Quality of Life assessment using European Organization for Research and Treatment of Cancer-30 with Brain20 module scores

Incidence and Severity of adverse events (AEs) and clinically significant changes in laboratory values

+6 more

CYNK001GBM02 Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase IIa Surgical rGBM CYNK-001 at MPD IV and ICExperimental Treatment1 Intervention

To evaluate efficacy and safety of CYNK-001 administrations in recurrent GBM at maximum tolerated dose for IV and IC per Phase 1 outcome. No patients staggering will be implemented in phase 2a. DMC will review the phase 2a entirely

Group II: Phase 1Surgical rGBM CYNK-001 infusion ( IV and IC) in combination with IL-2Experimental Treatment1 Intervention

Phase 1 dose escalation will utilize a 3+3 dose escalation design and will evaluate safety, feasibility, and preliminary efficacy of four cohort dose levels of CYNK-001 administered after a 6M IU subcutaneous dose of rhIL-2 for both IV and IC cycles. Up to 21 patients will be enrolled over 4 dosing cohorts in Phase 1.

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Find a Location

Who is running the clinical trial?

Celularity IncorporatedLead Sponsor

16 Previous Clinical Trials

627 Total Patients Enrolled

1 Trials studying Glioblastoma

3 Patients Enrolled for Glioblastoma

Adrian Kilcoyne, MDStudy DirectorCelularity inc

3 Previous Clinical Trials

192 Total Patients Enrolled

Mark Awadalla, B.SStudy DirectorCelularity inc

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are eligible for inclusion in this research trial?

"Celularity Incorporated, the sponsor of this study, needs 66 qualified participants to initiate it. The trial will be hosted at Northwestern University in Chicago, Illinois and Hackensack Medical Centre located in New jersey."

Answered by AI

How many locations are conducting this experiment?

"This medical trial is being run at multiple sites, including Northwestern University in Chicago, Hackensack in Hackensack and MD Anderson in Houston to name a few."

Answered by AI

Are there any openings for participants in this clinical investigation?

"Affirmative. According to information on clinicaltrials.gov, enrollment for this medical trial is ongoing since it was first posted in March 8th 2022 and last updated November 4th 2022. This research requires 66 people from 6 different centres to join the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CYNK-001 IV and IC in Combination With IL2 in Surgical Eligible Recurrent GBM With IDH-1 Wild Type

2022. "CYNK-001 IV and IC in Combination With IL2 in Surgical Eligible Recurrent GBM With IDH-1 Wild Type". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05218408.