Ignite Creation Date:
2024-05-06 @ 12:32 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03789617
Status:
RECRUITING
Last Update Posted:
2022-07-11
First Post:
2018-12-27
Brief Title:
A Multi-center Single-arm Open Phase IIIa 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
Sponsor:
Eutilex
Organization:
Eutilex
Study Overview
Official Title:
A Multi-center Single-arm Open Phase IIIa 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
Status:
RECRUITING
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study is a multi-center single-arm open phase IIIa 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 35- 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 IIIa 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 35
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 16 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 26 Begin enrollment for phase IIa at 70x108 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 70x108 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 products 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
After proving the safety through Part 1 and part 2 the efficacy and safety would be studied through part 35
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 16 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 26 Begin enrollment for phase IIa at 70x108 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 70x108 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 products 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None