This study will find the maximum safe dose (MSD) or maximum tolerated dose (MTD) of CYNK-001 which are NK cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given after lymphodepleting chemotherapy for the systemic cohort (IV) (intravenous). The intratumoral cohort (IT) will not be giving lymphodepletion. The safety of this treatment will be evaluated, and researchers want to learn if NK cells will help in treating recurrent glioblastoma multiforme.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Planned Starting dose dor IV 1.2x10\^9 cells/dose
Planned starting dose for IT 200 x10\^6 +/- 50 x10\^6 cells dose
The Univeristy of Texas MD ANderson Cancer Center
Houston, Texas, United States
Number of Participants who experienced a Dose-Limiting Toxicity (DLT)
Defined as the maximum dose safely administered intravenously or Intratumoral for the treatment of patients with GBM.
Time frame: Day 42
Adverse Events (AEs)
Defined as the number and Severity of Adverse Events
Time frame: 1 year
Overall Response Rate
Defined as the proportion of subjects with best overall response of either complete response (CR) or partial response (PR)
Time frame: 1 year
Duration of Response Rate
Defined as duration from first observation of partial response (PR) or better to the date of disease progression per RANO criteria
Time frame: 1year
Progression-free survival
Defined as date of the first CYNK-001 infusion to the date of disease progression per RANO Response Criteria or death (regardless of cause of death), whichever comes first
Time frame: 1year
Time to porgression
Defined as the date of the first CYNK-001 infusion to the date of disease progression per RANO Response Criteria, with deaths from causes other than progression censored
Time frame: 1year
Overall Survival
Defined as the date of the first CYNK-001 infusion to the date of death
Time frame: 1year
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