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

No Placebo-Only Group

Summary

This trial tests a new treatment using special immune cells and a protein to boost the immune system in adults with a recurring type of brain cancer. The goal is to see if this combination is safe and effective.

Eligible Conditions

Glioblastoma
Brain Tumor

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Overall survival phase I and IIa

Phase 1-Progression free survival at 6 Months

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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