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A Phase I/II Study of Intratumoral Injection of SD-101

NCT02254772 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-11-27

Study results available
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Summary

This phase 1-2 trial studies the side effects and best dose of ipilimumab in combination with toll-like receptor 9 (TLR9) agonist SD-101 and radiation therapy in treating patients with recurrent low-grade B-cell lymphoma.

Conditions

  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Nodal Marginal Zone B-cell Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Splenic Marginal Zone Lymphoma

Interventions

BIOLOGICAL

Ipilimumab

A dose of 10 mg in cohort 1 or 25mg in cohort 2 via intratumoral injection on day 2, week 1.

DRUG

SD-101

Started on day 2 week 1, then once every week x 4 successive weeks for a total of 5 injections.

RADIATION

Radiation therapy

Undergo low-dose radiation therapy to 1 site of disease

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Robert Lowsky

    lead OTHER

Principal Investigators

  • Ronald Levy, MD · Stanford University Hospitals and Clinics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-11-10
Completion
2017-01-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02254772 on ClinicalTrials.gov