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In Situ Vaccine for Low-Grade Lymphoma: Combination of Intratumoral Flt3L and Poly-ICLC With Low-Dose Radiotherapy

NCT01976585 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-09-22

No results posted yet for this study

Summary

Our recent trials combining local radiotherapy with intratumoral administration of TLR agonists - referred to as 'in situ vaccination' - for patients with low-grade lymphoma demonstrated safety, induction of anti-tumor CD8 T cell responses and partial and complete remissions of patients' non-irradiated sites of disease with complete remissions lasting from months to more than three years.

This iteration of the in situ vaccine approach builds on our prior work in ways that should improve its efficacy, by adding Flt3L and changing the toll-like receptors (TLR) agonist to poly-ICLC -an optimal TLR agonist for the type of dendritic cells (DC) recruited by Flt3L. The vaccine is thus in 3 phases:

1. intratumoral Flt3L administration recruits DC to the tumor
2. low-dose radiotherapy to release tumor antigens
3. intratumoral poly-ICLC administration activates tumor-antigen loaded DC

Conditions

  • Low-Grade B-cell Lymphoma

Interventions

DRUG

rhuFlt3L/CDX-301

rhuFlt3L/CDX-301 is a truncated, soluble, recombinant human fms-like tyrosine kinase-3 ligand (Flt3L), expressed in a Chinese hamster ovary cell. RhuFlt3L/CDX-301 is formulated as a sterile solution intended for single-use parenteral administration. Each vial contains 2.5 mg/mL rhuFlt3L/CDX-301 in a 1 mL of buffered solution composed of Sodium Phosphate and Sodium Chloride, with a pH of 7.

DRUG

Poly-ICLC

Poly-ICLC is supplied by Oncovir in single-dose vials containing 1 mL of 2 mg/mL opalescent white suspension. Each milliliter of Poly-ICLC for injection contains 2 mg/mL poly-IC, 1.5 mg/mL poly-L-lysine, and 5 mg/mL sodium carboxymethylcellulose in 0.9% sodium chloride solution and adjusted to pH 7.6-7.8 with sodium hydroxide.

Sponsors & Collaborators

  • Celldex Therapeutics

    collaborator INDUSTRY

  • Joshua Brody

    lead OTHER

Principal Investigators

  • Joshua Brody, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-03
Primary Completion
2020-11-20
Completion
2020-11-20

Countries

  • United States

Study Locations

More Related Trials

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 NCT01976585 on ClinicalTrials.gov