drugset / Trial / NCT02223312

Therapy for Progressive and/or Refractory Hematologic Malignancies

NCT02223312

Phase 1/2 Withdrawn Kiromic BioPharma Inc.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

Summary

The purpose of this study is to evaluate the safety and effectiveness of Tumor Associated Peptide Antigen (TAPA) pulsed dendritic cell (DC) vaccines in the treatment of progressive and/or refractory hematologic malignancies (HM). We hypothesize that treatment of patients with relapsed and/or refractory HM, without available potentially curative treatment options, and whose neoplastic cells express at least one (1) TAPA of a defined panel of TAPAs, using low-dose cyclophosphamide (CYP) followed by an autologous, monocyte-derived, TAPA-pulsed DC vaccine and low-dose granulocyte macrophage colony stimulating factor (GM-CSF), will result in TAPA-specific T-cell responses without significant toxicities. We also hypothesize CD4+ T-cell 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