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

Part of paid clinical trials in Stanford, California.

Sponsor
Robert Lowsky
Study ID
NCT02254772
Phase
PHASE1/PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    A dose of 10 mg in cohort 1 or 25mg in cohort 2 via intratumoral injection on day 2, week 1.
  • SD-101 — DRUG
    Started on day 2 week 1, then once every week x 4 successive weeks for a total of 5 injections.
  • Radiation therapy — RADIATION
    Undergo low-dose radiation therapy to 1 site of disease

Study Details

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.

Key Dates

Start date
Sep 30, 2014
Status verified
Feb 2017
Primary completion
Nov 10, 2016
Completion
Jan 26, 2017

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Patients receive TLR9 agonist SD-101 via intratumoral injections; ipilimumab via intratumoral injection; and undergo radiation therapy on days 1 and 2.

Primary Outcome Measure

Number of Dose-limiting Toxicity (DLT) Events of Ipilimumab Plus a Fixed Dose of SD-101 (1 mg/Week) [ Time Frame: Up to 10 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Hospitals and ClinicsStanfordCalifornia94305-

Find similar trials in Stanford, CA

By research site
Stanford University Hospitals and Clinics· Stanford, CA

Related Studies