Ignite Creation Date:
2024-05-06 @ 3:11 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02224599
Status:
TERMINATED
Last Update Posted:
2020-04-24
First Post:
2014-08-11
Brief Title:
Cyclophosphamide TAPA-Pulsed Dendritic Cell Therapy and Imiquimod in Progressive andor Refractory Solid Malignancies
Sponsor:
Kiromic BioPharma Inc
Organization:
Kiromic BioPharma Inc
Study Overview
Official Title:
Phase III Study of Low-Dose Cyclophosphamide Tumor Associated Peptide Antigen-Pulsed Dendritic Cell Therapy and Imiquimod in Patients With Progressive andor Refractory Solid Malignancies
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision to terminate study due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients diagnosed with progressive andor refractory solid malignancies who have failed conventional therapy and have no available potentially curative therapeutic options will be candidates for this Phase III study Following confirmation of disease progression andor refractoriness eligible patients who agree to participate and sign an informed consent form will have their tumor cellstissues andor blood analyzed for the expression of a specific panel of Tumor Associated Peptide Antigens TAPAs including Sp17 ropporin AKAP-4 PTTG1 Span-xb Her-2neu HM124 NY-ESO-1 and MAGE-1
Detailed Description:
For patients whose tumors express one 1 or more of these TAPAs Sp17 ropporin AKAP-4 PTTG1 Span-xb Her-2neu HM124 NY-ESO-1 and MAGE-1 whole blood will be obtained by phlebotomy andor leukapheresis performed for generation of autologous DCs Patients DCs will be generated in Kiromics Cell Processing GMP facility according to established Standard Operating Procedures and activated by pulsingloading them with the TAPAs relevant for each particular patient Patients will receive five 5 days of low-dose cyclophosphamide 5 to 7 days prior to each vaccination with TAPA-pulsed DCs to decrease Treg activity Patients will also receive a single dose of topical Imiquimod cream after each vaccination TAPA-pulsed DCs will be administered at a fixed dose of up to 1 X 107 DCs DC vaccination schedule will be weekly via intradermal ID injections for a total of 3 vaccinations Topical Imiquimod cream will also be administered once after the vaccination Patients will be followed on a weekly basis or more frequently if required to evaluate treatment-related toxicity Immune efficacy and anti-tumor responses will be evaluated per protocol specifications Continuation and stopping rules for the study will be defined based on toxicitytolerability Phase I and immune efficacy Phase II
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None