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

Status Completed

Clinical Trial 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.

Clinical Trial Description

Monoclonal antibodies, such as ipilimumab, may block cancer growth in different ways by targeting certain cells. Biological therapies, such as TLR9 agonist SD-101, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving ipilimumab in combination with TLR9 agonist SD-101 and radiation therapy may be a better treatment for B-cell lymphoma.

Study objectives are dose-limiting toxicity (DLT) and the treatment assessments tumor response and time-to-progression. Cohort 1 dose level is 10 mg ipilimumab, subsequent cohort is 5 or 25 mg ipilimumab.

- If 2 out of 6 patients experience a DLT in the first cohort (10 mg ipilimumab), the dose will be de-escalated to 5 mg ("Cohort -1").

- If 2 out of 6 patients experience a DLT at the 5 mg dose level, then the study will be stopped. ;

Study Design

Related Conditions & MeSH terms

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Follicular
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

Clinical Trial Details

NCT number	NCT02254772
Study type	Interventional
Source	Stanford University
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	September 2014
Completion date	January 26, 2017

View Details

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