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)
This Phase 1/2a, open-label, multicenter, non-randomized study was designed to evaluate the safety, feasibility, and preliminary efficacy of CYNK-001 in combination with recombinant human interleukin-2 (rhIL-2) in adults with recurrent resection-eligible IDH1 wild-type glioblastoma (GBM). The Phase 1 portion was intended to assess the safety and feasibility of intravenous and intracavitary administration of CYNK-001 following tumor resection and to determine the maximum tolerated dose (MTD) and recommended Phase 2a dose (RP2D). The Phase 2a portion was intended to evaluate efficacy and safety, including progression-free survival at 6 months (PFS6M). The study was withdrawn prior to enrollment, and no participants were enrolled or treated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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 The study was withdrawn prior to enrollment and no participants were treated.
Phase I-Number of patients experience Dose limiting toxicity (DLT)
Defined as the maximum dose safely administered intravenously or Intracavitary for the treatment of patients with GBM
Time frame: 42 days
To establish maximum tolerated dose (MTD) and a Recommended Phase 2a Dose (RP2D)
Defined as the number of patients experience Adverse Events and severity
Time frame: 42 days
Phase IIa CYNK-001 efficacy
To evaluate CYNK-001 efficacy post tumor resection and survival within PFS6 Month
Time frame: 6 Months
Phase 1-Progression free survival at 6 Months
is defined as the time from the tumor resection to the date of first documented disease progression determined in accordance with RANO (and iRANO) or death due to any reason, whichever occurs first
Time frame: 6 Months
Overall survival phase I and IIa
is defined as the time from the tumor resection until the date of death at 6,9 and 12 months
Time frame: 6,9 and 12 months
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