The present study is a multi-center, single-arm, open, phase I/IIa clinical trial to evaluate the efficacy and safety of EBViNT Cell when administered to patients with Epstein-Barr (EBV) positive malignancies The present study investigates with 5 parts; Part1-phase I: IP single therapy on ENKL and solid tumors Part2-phase I: IP + lymphodepletion on solid tumors Part 3\&5- Phase IIa: IP single therapy on each ENKL and solid tumors Part 4- Phase IIa: IP + lymphodepletion on solid tumors
The present study is a multi-center, single-arm, open, phase I/IIa clinical trial to evaluate the efficacy and safety of EBViNT Cell when administered to patients with Epstein-Barr (EBV) positive tumors After proving the safety through Part 1 and part 2, the efficacy and safety would be studied through part 3\~5. * If CTCAE grade 3 or higher adverse drug events (ADR) do not occur in the three subjects: Begin enrollment for phase IIa * If a CTCAE grade 3 or higher ADR occurs in one of the three subjects: Enroll three more subjects (up to six subjects in total) and assess whether any CTCAE grade 3 or higher ADR occurs * If a CTCAE grade 3 or higher ADR does not occur in the three additional subjects (1/6): Begin enrollment for phase IIa * If a CTCAE grade 3 or higher ADR occurs in at least one of the three additional subjects (more than 2/6): Begin enrollment for phase IIa at 7.0x10\^8 cells, the maximum dose from phase I * If a CTCAE grade 3 or higher ADR occurs in two of the three subjects: Begin enrollment for phase IIa at 7.0x10\^8 cells, the maximum dose from phase I Subjects participating in the present study will undergo 1) an EBV epitope screening test followed by 2) an eligibility assessment for clinical trial enrollment. Subjects who are administered with the investigational product will be monitored until progressive disease (PD) is confirmed or for 24 weeks (main observation period of 4 weeks + monitoring for 20 weeks) to evaluate the product's safety and efficacy, and will undergo immunological assessment. Radiological tests for tumor assessment will be conducted at the enrollment visit, 4 weeks, 8 weeks, 16 weeks, and 24 weeks and assessed by the Independent Radiology Review Committee (IRRC) using the Lugano criteria. To eliminate pseudo-progression, progressive disease (PD) will be determined by considering immunological tests, a quantitative EBV DNA assay, and intermediate response (IR) under LYRIC. Biopsies may be performed to achieve this.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
1. Dosage: 1 bag containing 1.4x10\^9 cells/100mL 2. Administration: Inject intravenously over 30 minutes 3. Dosing schedule: Single dose
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
NOT_YET_RECRUITINGNational Cancer Center
Goyang-si, Gyeonggi-do, South Korea
NOT_YET_RECRUITINGInje Univ. Hosp
Pusan, South Korea
NOT_YET_RECRUITINGPusan national Univ. Hosp.
Pusan, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
NOT_YET_RECRUITINGSeoul Asan Medical center
Seoul, South Korea
NOT_YET_RECRUITINGSeverance hosp.
Seoul, South Korea
NOT_YET_RECRUITINGAjou Univ Hosp.
Suwon, South Korea
NOT_YET_RECRUITINGConfirmed objective response rate (confirmed ORR) [assessed by IRRC]
Time frame: up to 6 month from LPI
Duration of response (DoR) [assessed by IRRC and investigator]
Time frame: up to 6 month from LPI
Disease control rate (DCR) [assessed by IRRC and investigator]
Time frame: up to 6 month from LPI
Objective response rate (ORR) [assessed by investigator]
Time frame: up to 6 month from LPI
Complete response rate (CR rate) [assessed by IRRC and investigator]
Time frame: up to 6 month from LPI
Partial response rate (PR rate) [assessed by IRRC and investigator]
Time frame: up to 6 month from LPI
Partial response duration (PR duration) [assessed by IRRC and investigator]
Time frame: up to 6 month from LPI
Progression-free survival (PFS)
Time frame: up to 6 month from LPI
Overall survival (OS)
Time frame: up to 6 month from LPI
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