MedTrace Logo

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

NCT05218408 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2026-06-08

No results posted yet for this study

Summary

A Phase 1/2a Open Label Multicenter, Non-Randomized, Trial to Assess the Safety and Efficacy of CYNK-001 in Combination with Recombinant Human Interleukin-2 in Adults with Recurrent Resection Eligible IDH1 wild-type Glioblastoma. For phase I portion, the study objectives to assess the safety and feasibility CYNK-001 in combination with rhIL2 of Intravenous (IV) infusion and Intracavitary (IC) administrations following tumor resection and to establish a maximum tolerated dose (MTD) and a Recommended Phase 2a Dose (RP2D) for IV and IC CYNK-001 administration. For Phase IIa, to evaluate efficacy and safety of CYNK-001 administrations in recurrent GBM as measured by Progression Free Survival at 6 months (PFS6M)

Conditions

Interventions

BIOLOGICAL

CYNK-001 systemic and Intra cavity administration

CYNK-001 administered intravenously and intracavitarily in combination with subcutaneous recombinant human IL-2 following lymphodepleting chemotherapy. The study was designed to evaluate escalating dose levels of CYNK-001 in Phase 1 and the recommended dose in Phase 2a. The study was withdrawn prior to enrollment and no participants were treated.

Sponsors & Collaborators

  • Celularity Incorporated

    lead INDUSTRY

Principal Investigators

  • sharmila koppisetti, MD · Celularity Incorporated

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2021-10-23
Completion
2021-10-23
FDA Drug
Yes

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 NCT05218408 on ClinicalTrials.gov