Ph2 NK Cell Enriched DCIs w/wo RLR9 Agonist, DUK-CPG-001 From Donors Following Allogeneic SCT

Summary

This is a randomized, parallel phase II study to evaluate the rates of progression-free survival and unacceptable toxicity in patients receiving NK cell-enriched donor lymphocyte infusions (DLIs) when administered alone or administered with the TLR9 agonist, DUK-CPG-001, from a 7-8/8 HLA-matched related or unrelated donor (Cohort A) or 4-6/8 HLA-matched related donor (Cohort B) following reduced intensity or non-ablative allogeneic stem cell transplantation. Randomization will be stratified for disease types (myeloid versus lymphoid malignancies). Primary endpoints are analyzed separately in Cohort A and B.

Cohort A: 7-8/8 HLA-matched related or unrelated donor ("NK cell enriched-DLI only" arm or "NK cell enriched-DLI + DUK-CPG-001" arm)

Cohort B: 4-6/8 HLA-matched related donor ("NK cell enriched-DLI only" arm or "NK cell enriched-DLI + DUK-CPG-001" arm)

Conditions

• Myeloid Malignancies
• Lymphoid Malignancies

Interventions

BIOLOGICAL

NK Cell enriched-DLI only

The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously. If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started.

BIOLOGICAL

NK-DLI + DUK-CPG-001

DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing. On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI.

Sponsors & Collaborators

• Agilent Technologies, Inc.

  collaborator INDUSTRY

• Cristina Gasparetto

  lead OTHER

Principal Investigators

• Cristina Gasparetto, MD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-08

Primary Completion

2022-07-23

Completion

2024-10-31

Countries

• United States

Study Locations