Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-02-01 @ 2:33 AM
Study NCT ID:
NCT03742804
Status:
WITHDRAWN
Last Update Posted:
2019-12-18
First Post:
2018-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Of Intratumoral G100 In Cutaneous T Cell Lymphoma
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Pilot Phase 2 Study of Intratumoral G100 in Patients With Cutaneous T Cell Lymphoma
Status:
WITHDRAWN
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study sponsor sold and the new company would not support the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal of this study is to evaluate the safety and immunogenicity of repeat-dose intratumoral G100 administration in patients with Cutaneous T Cell Lymphoma (CTCL) alone (Part 1) and following standard local radiation therapy or topical nitrogen mustard application (Part 2). Plaque, patch, or tumor lesions of CTCL may be injected. Disease will be assessed in all sites, including skin, nodes, and blood.
Detailed Description:
This is a pilot, Phase II study of intratumoral or intralesional injection of G100 alone (Part 1) and in conjunction with topical nitrogen mustard (HN2) or radiotherapy (Part 2) in patients with CTCL to generate anti-tumor immune responses. To confirm the safety of the injections in this population, enrollment of the first four patients will be staggered by at least 21 days each. If there are no grade 3 adverse events following the first 4 injections in the first 3 patients, then subsequent patients can be enrolled without restriction to timing.
Part 1: All patients will receive 6 intratumoral G100 injections alone over 5 weeks (first dose on Day 0, second on Day 5-7, and then weekly thereafter; up to Week 5) to assess the response to G100 alone. Response in target lesions will be measured by CAILS and abscopal effect will be measured by Modified Severity Weighted Assessment Tool (MSWAT). If applicable, peripheral blood flow cytometry will be used to assess response of circulating tumor cells.
There will be a 4-week break for restaging.
Part 2: Patients will receive another 6 doses of G100 with either topical nitrogen mustard for 2 days or local radiotherapy (2 Gy daily x 2 days) prior to G100 to the injected lesion to assess the response to combination therapy. After the first 4 doses, nitrogen mustard is optional and can be omitted at the discretion of the investigator. Response in target lesions will be measured by Composite assessment of index lesion severity (CAILS) and abscopal effect will be measured by MSWAT. If applicable, peripheral blood flow cytometry will be used to assess response of circulating tumor cells.
* Dose regimen interruption in a single patient may be made by the clinical investigator if it is deemed in the best interest of patient safety.
* Tumor imaging will be performed during the screening visit (baseline) in patients with blood involvement, palpable nodes, or tumor stage disease (scans done within 4 weeks of study entry are admissible), and in patients with clinically suspicious positive scans (nodes felt to be involved, standardized uptake value (SUV) 4 or greater on positron emission tomography (PET), imaging will be repeated at the completion of 6 weeks of dosing
* Circulating Sezary cells will be followed if present at baseline. Quantitation of Sezary cells will be done by flow cytometry using appropriate markers.
* Pre- and post-treatment tumor biopsies will be obtained for histologic review and exploratory immune analyses, including cell phenotype and genomic analyses of T cells. On-treatment biopsies will be performed at Week 3 of both Parts 1 and 2 of the study. Peripheral blood will be drawn for immune assays and other biomarker tests at time points listed in the Schedule of Events and Study Procedures.
Primary Objective
* To evaluate the safety and to observe clinical responses (by MSWAT and CAILS) with intratumoral G100 alone and with G100 in combination with agents to induce apoptosis (local radiotherapy or topical nitrogen mustard) in patients with CTCL.
Secondary Objectives
* To assess abscopal tumor responses in non-treated, distal tumor sites by MSWAT and CAILS tools.
* To evaluate pre-and post-regimen tumor tissue and blood for exploratory biomarkers of immunologic and tumor response.
Part 1: All patients will receive 6 intratumoral G100 injections alone over 5 weeks (first dose on Day 0, second on Day 5-7, and then weekly thereafter; up to Week 5) to assess the response to G100 alone. Response in target lesions will be measured by CAILS and abscopal effect will be measured by Modified Severity Weighted Assessment Tool (MSWAT). If applicable, peripheral blood flow cytometry will be used to assess response of circulating tumor cells.
There will be a 4-week break for restaging.
Part 2: Patients will receive another 6 doses of G100 with either topical nitrogen mustard for 2 days or local radiotherapy (2 Gy daily x 2 days) prior to G100 to the injected lesion to assess the response to combination therapy. After the first 4 doses, nitrogen mustard is optional and can be omitted at the discretion of the investigator. Response in target lesions will be measured by Composite assessment of index lesion severity (CAILS) and abscopal effect will be measured by MSWAT. If applicable, peripheral blood flow cytometry will be used to assess response of circulating tumor cells.
* Dose regimen interruption in a single patient may be made by the clinical investigator if it is deemed in the best interest of patient safety.
* Tumor imaging will be performed during the screening visit (baseline) in patients with blood involvement, palpable nodes, or tumor stage disease (scans done within 4 weeks of study entry are admissible), and in patients with clinically suspicious positive scans (nodes felt to be involved, standardized uptake value (SUV) 4 or greater on positron emission tomography (PET), imaging will be repeated at the completion of 6 weeks of dosing
* Circulating Sezary cells will be followed if present at baseline. Quantitation of Sezary cells will be done by flow cytometry using appropriate markers.
* Pre- and post-treatment tumor biopsies will be obtained for histologic review and exploratory immune analyses, including cell phenotype and genomic analyses of T cells. On-treatment biopsies will be performed at Week 3 of both Parts 1 and 2 of the study. Peripheral blood will be drawn for immune assays and other biomarker tests at time points listed in the Schedule of Events and Study Procedures.
Primary Objective
* To evaluate the safety and to observe clinical responses (by MSWAT and CAILS) with intratumoral G100 alone and with G100 in combination with agents to induce apoptosis (local radiotherapy or topical nitrogen mustard) in patients with CTCL.
Secondary Objectives
* To assess abscopal tumor responses in non-treated, distal tumor sites by MSWAT and CAILS tools.
* To evaluate pre-and post-regimen tumor tissue and blood for exploratory biomarkers of immunologic and tumor response.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: