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Oligonucleotide

CpG-STAT3 siRNA + Radiation Therapy for B-Cell Lymphoma

Phase 1

Waitlist Available

Led By Lihua E Budde

Research Sponsored by City of Hope Medical Center

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 up to 6 months

Awards & highlights

Study Summary

This trial is testing the best dose and side effects of CAS3/SS3 combined with localized radiation therapy to treat patients with B-cell NHL that has relapsed or is refractory.

Eligible Conditions

Non-Hodgkin's Lymphoma
Diffuse Large B-Cell Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
Marginal Zone Lymphoma
Lymphoma
B-Cell Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Limiting Toxicity

Incidence of adverse events

Secondary outcome measures

Activation of immune cells

Overall response

Response duration

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (radiation therapy, CAS3/SS3)Experimental Treatment2 Interventions

Patients undergo radiation therapy on days 1 and 2 tumor-bearing lymph node, and receive CAS3/SS3 intratumorally on days 2, 4, 16, and 18. Patients assigned to dose level 3 also receive CAS3/SS3 intratumorally on days 9, 11, 23, and 25.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,460 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,153 Total Patients Enrolled

Lihua E BuddePrincipal InvestigatorCity of Hope Medical Center

1 Previous Clinical Trials

36 Total Patients Enrolled

Media Library

CpG-STAT3 siRNA CAS3/SS3 (Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT04995536 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: Treatment (radiation therapy, CAS3/SS3)

Non-Hodgkin's Lymphoma Clinical Trial 2023: CpG-STAT3 siRNA CAS3/SS3 Highlights & Side Effects. Trial Name: NCT04995536 — Phase 1

CpG-STAT3 siRNA CAS3/SS3 (Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04995536 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Radiation Therapy been sanctioned by the Food and Drug Administration?

"Given the preliminary nature of this clinical trial, radiation therapy received a score of 1 in terms of safety. This reflects limited data regarding its efficacy and security profile."

Answered by AI

What is the magnitude of subjects taking part in this research?

"Affirmative. Clinicaltrials.gov displays that this clinical trial, first posted on August 1st 2022, is actively searching for participants to enrol in the study. The research team needs 18 people from a single site to complete their goals of the experiment."

Answered by AI

What are the expected outcomes of this trial?

"This medical trial aims to assess Dose Limiting Toxicity over a 6-month period. Secondary objectives include evaluating Overall Response using the Lugano criteria, monitoring STAT3 activation of relevant gene expression via Nanostring technology in lymph node tissue and assessing serum IFN, IP-10, MCP1 levels as evidence for systemic effects following CAS3/SS3 injections."

Answered by AI

Are there still openings for individuals to join this investigation?

"Correct. According to information posted on clinicaltrials.gov, this medical experiment is currently recruiting participants. The trial was originally opened for recruitment on August 1st 2022 and last updated June 10th 2022. A total of 18 patients are sought from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CpG-STAT3 siRNA CAS3/SS3 and Localized Radiation Therapy for the Treatment of Relapsed/Refractory B-Cell NHL

2023. "CpG-STAT3 siRNA CAS3/SS3 and Localized Radiation Therapy for the Treatment of Relapsed/Refractory B-Cell NHL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04995536.