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)

Timeline

Start

2016-06-08

Primary completion

2022-07-23

Completion

2024-10

Outcome

Missed primary endpoint

registry analysis (superiority test); Cohort A - NK Cell Enriched-DLI Only vs Cohort A - NK-DLI + DUK-CPG-001 vs Cohort B - NK Cell Enriched-DLI Only vs Cohort B - NK-DLI + DUK-CPG-001; p = 0.40; Log Rank NCT02452697 ↗

Drugs

Indications