A Multi-center, Single-arm, Open, Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of EBViNT Cell (EBV Specific Autologous CD8+ T Cell) in Patients With Treatment Failed Epstein Barr Virus (EBV)-Positive Malignancies
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- EBV Associated Extranodal NK/T-cell Lymphoma
- Sponsor
- Eutilex
- Enrollment
- 72
- Locations
- 7
- Primary Endpoint
- Confirmed objective response rate (confirmed ORR) [assessed by IRRC]
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Confirmed objective response rate (confirmed ORR) [assessed by IRRC]
Time Frame: up to 6 month from LPI
Secondary Outcomes
- Duration of response (DoR) [assessed by IRRC and investigator](up to 6 month from LPI)
- Complete response rate (CR rate) [assessed by IRRC and investigator](up to 6 month from LPI)
- Progression-free survival (PFS)(up to 6 month from LPI)
- Disease control rate (DCR) [assessed by IRRC and investigator](up to 6 month from LPI)
- Objective response rate (ORR) [assessed by investigator](up to 6 month from LPI)
- Partial response duration (PR duration) [assessed by IRRC and investigator](up to 6 month from LPI)
- Overall survival (OS)(up to 6 month from LPI)
- Partial response rate (PR rate) [assessed by IRRC and investigator](up to 6 month from LPI)