This is a first-in-human Phase 1 multicenter, open-label oncology study designed to evaluate the safety and efficacy of NX-DeTIL-0255-201 in patients with advanced malignancies.
This study includes a safety run in and a cohort expansion. The safety run in will include patients with any of the indications under study including: Recurrent or persistent platinum-resistant epithelial ovarian cancer (EOC), including primary peritoneal and fallopian tube carcinoma Recurrent, metastatic, or persistent cervical carcinoma Advanced or recurrent endometrial cancer Cohort expansion will include patients with advanced malignancies who have received at least two prior systemic therapies in the same indications.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Autologous tumor-infiltrating lymphocytes
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC
Pittsburgh, Pennsylvania, United States
Incidence of treatment emergent adverse events
NX-DeTIL-0255-201
Time frame: 24 Months
Incidence of all deaths
NX-DeTIL-0255-201
Time frame: 24 Months
Incidence of dose limiting toxicities
NX-DeTIL-0255-201
Time frame: 24 Months
Objective response rate (ORR) per disease-specific response criteria as assessed by the Investigator
NX-DeTIL-0255-201
Time frame: 24 Months
Duration of response (DOR) as assessed by the Investigator
NX-DeTIL-0255-201
Time frame: 24 Months
Disease control rate (DCR) as assessed by the Investigator
NX-DeTIL-0255-201
Time frame: 24 Months
Progression-free survival (PFS) as assessed by the Investigator
NX-DeTIL-0255-201
Time frame: 24 Months
Overall survival (OS) as assessed by the Investigator
NX-DeTIL-0255-201
Time frame: 24 Months
Changes from baseline in immune cell infiltration in the tumor following DeTIL-0255 infusion
NX-DeTIL-0255-201
Time frame: 24 Months
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