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Virus Therapy

Poly-ICLC for B-Cell Lymphoma

Phase 1 & 2
Waitlist Available
Led By Joshua Brody, MD
Research Sponsored by Joshua Brody
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Study Summary

This trial 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.

Eligible Conditions
  • B-Cell Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
response rate
Secondary outcome measures
safety profile
tumor-specific immune response

Side effects data

From 2022 Phase 1 & 2 trial • 58 Patients • NCT02643303
53%
Chills
47%
Fatigue
47%
Nausea
47%
Injection site pain
33%
Dizziness
27%
Vomiting
27%
Influenza like illness
20%
Pyrexia
20%
Dyspnoea
20%
Malignant neoplasm progression
20%
Diarrhoea
20%
Myalgia
20%
Pruritus
20%
Headache
13%
Anaemia
13%
Urinary tract infection
13%
Tachycardia
13%
Neuropathy peripheral
13%
Contusion
13%
Nasal congestion
13%
Abdominal distention
13%
Malaise
13%
Weight decreased
13%
Cough
13%
Rash
13%
Musculoskeletal chest pain
7%
Palpitations
7%
Eye swelling
7%
Gastrooesophageal reflux disease
7%
Skin infection
7%
Soft tissue infection
7%
Vision blurred
7%
Lymph node pain
7%
Constipation
7%
Neutrophil count decreased
7%
Amylase increased
7%
Depression
7%
Hypoxia
7%
Vulvovaginal discomfort
7%
Rhinitis allergic
7%
Hypotension
7%
Oropharyngeal pain
7%
Hypokalaemia
7%
Pain in extremity
7%
Metastases to bone
7%
Abdominal pain upper
7%
Dyspepsia
7%
Upper respiratory tract infection
7%
Fall
7%
Vaginal infection
7%
Procedural pain
7%
Musculoskeletal pain
7%
Vulvovaginal pruritus
7%
Pneumonia
7%
Dehydration
7%
Facial paresis
7%
Hypothyroidism
7%
Visual impairment
7%
Dry mouth
7%
Injection site erythema
7%
Early satiety
7%
Sunburn
7%
Blood creatinine increased
7%
Activated partial thromboplastin time prolonged
7%
Weight increased
7%
Blood cortisol increased
7%
Electrocardiogram QT prolonged
7%
Decreased appetite
7%
Hypomagnesaemia
7%
Hyponatraemia
7%
Hyperglycaemia
7%
Arthralgia
7%
Bone pain
7%
Joint swelling
7%
Dizziness postural
7%
Breast swelling
7%
Rash maculo-papular
7%
Abscess drainage
7%
Post procedural drainage
7%
Hypertension
7%
Flushing
7%
Lymphocyte count decreased
7%
Flank pain
7%
Neck pain
7%
Back pain
7%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer
Phase 1, Cohort 1B
Cohort 1C + Phase 2; Sarcoma
Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases
Cohort 1C + Phase 2; Solid Tumors With Accessible Masses
Cohort 1C + Phase 2; Head + Neck Squamous Cell Carcinoma
Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies
Cohort 1C + Phase 2; Merkel Cell Carcinoma
Phase 1, Cohort 1A

Trial Design

1Treatment groups
Experimental Treatment
Group I: rhuFlt3L/CDX-301Experimental Treatment2 Interventions
intratumoral injections on days 1-5 and 8-11. and Poly-ICLC intratumoral injection weekly, weeks 2-8
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Poly-ICLC
2016
Completed Phase 2
~240
rhuFlt3L/CDX-301
2014
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Joshua BrodyLead Sponsor
1 Previous Clinical Trials
21 Total Patients Enrolled
Celldex TherapeuticsIndustry Sponsor
60 Previous Clinical Trials
3,849 Total Patients Enrolled
Joshua Brody, MD5.03 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
3 Previous Clinical Trials
83 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Clinical OncologyJournal
In Situ Vaccination with a TLR9 Agonist Induces Systemic Lymphoma Regression: A Phase I/II Study
Brody, Joshua D., Weiyun Z. Ai, Debra K. Czerwinski, James A. Torchia, Mia Levy, Ranjana H. Advani, Youn H. Kim, et al.. 2010. “In Situ Vaccination with a TLR9 Agonist Induces Systemic Lymphoma Regression: A Phase I/II Study”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2010.28.9793.
clinicaltrials.govStudy
In Situ Vaccine for Low-Grade Lymphoma: Combination of Intratumoral Flt3L and Poly-ICLC With Low-Dose Radiotherapy
Joshua Brody 2014. "In Situ Vaccine for Low-Grade Lymphoma: Combination of Intratumoral Flt3L and Poly-ICLC With Low-Dose Radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01976585.
~2 spots leftby Apr 2025
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