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NM-IL-12 (rHuIL-12) In Relapsed/Refractory Diffuse Large B- Cell Lymphoma (DLBCL) Undergoing Salvage Chemotherapy

NCT02544724 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-08-03

No results posted yet for this study

Summary

NM-IL-12 is being evaluated as an immunotherapeutic with concomitant hematopoietic regenerating properties for treatment of relapsed/refractory DLBCL, an aggressive type of B-cell non-Hodgkin's lymphoma (NHL). Determination of the maximum tolerated dose (MTD) for NM-IL-12 is not planned in this study, rather, a pre-defined dose of 150 ng/kg will be explored; this dose is based on two safety and tolerability studies of NM-IL-12 in healthy volunteers.

Conditions

  • Lymphoma, Large B-Cell, Diffuse (DLBCL)

Interventions

BIOLOGICAL

NM-IL-12

Single SC administration of NM-IL-12 will be administered at least 48 hours after completion of the last chemotherapy dose of each cycle

Sponsors & Collaborators

  • Neumedicines Inc.

    lead INDUSTRY

Principal Investigators

  • Yossef Kalish, MD · Hadassah Medical Organization

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-08-31
Completion
2017-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02544724 on ClinicalTrials.gov