drugset / Trial / NCT02705703

Consolidation Therapy in Patients With Metastatic Solid Malignancies

NCT02705703

Phase 1/2 Withdrawn Kiromic BioPharma Inc.
NaSingle-groupOpen-labelTreatment

Summary

This study evaluates the effectiveness of Tumor Associated Peptide Antigens (TAPA) pulsed dendritic cell injections as a potential consolidation therapy for patients with metastatic solid malignancies (SM). The investigators hypothesize that treatment of patients with metastatic SM who demonstrate a tumor response, or whose disease remains stable, after conventional first-line systemic therapy AND who lack an available, potentially curative therapeutic intervention and whose tumor cells and/or blood express at least one (1) TAPA of a defined panel of TAPAs will result in TAPA-specific T-cell responses without significant toxicities. The investigators also hypothesize CD4+ and CD8+ T-cell responses generated against specific TAPAs may translate into clinical antitumor activity.

Timeline

Start
2017-07-28
Primary completion
2018-10-31
Completion
2019-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject TAPA-pulsed DC vaccine Cell therapy 1e+07 cells Subcutaneous
Background Cyclophosphamide Other / unclassified 100 mg Oral
Background sargramostim Protein / enzyme biologic 50 ug Subcutaneous