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Gene Therapy

Ad-p53 for Lymphoma

Phase 2

Waitlist Available

Research Sponsored by MultiVir, Inc.

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 change in tumor size at the end of cycle 2 (each cycle is 28 days)

Awards & highlights

Study Summary

This trial is testing a combination of a gene therapy and an approved cancer immunotherapy in people with recurrent or metastatic cancers, to see if it is safe and effective.

Eligible Conditions

Lymphoma
Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in tumor size at the end of cycle 2 (each cycle is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in tumor size at the end of cycle 2 (each cycle is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in tumor size at the end of cycle 2 (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Safety assessments of adverse events per CTCAE

The primary efficacy endpoint is objective response rate (ORR)

Secondary outcome measures

Preliminary assessment of Duration of Response (DoR) by RECIST 1.1

Preliminary assessment of progression free survival (PFS) by RECIST 1.1

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ad-p53 with anti-PD-1/anti-PD-L1 100% of patientsExperimental Treatment1 Intervention

Up to 40 patients, all patients treated with intra-tumoral Ad-p53 (dose determined by tumor size) in combination with IV physician's choice of approved immune checkpoint inhibitor

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MultiVir, Inc.Lead Sponsor

2 Previous Clinical Trials

18 Total Patients Enrolled

Frequently Asked Questions

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

Are there still vacancies for participants in this research endeavor?

"Affirmative. According to the information posted on clinicaltrials.gov, this research is currently recruiting individuals for participation. It was initially publicized on October 1st 2018 and has been recently updated as of June 5th 2020; 40 participants across 3 sites are being sought after."

Answered by AI

What maladies can Ad-p53 be utilized to ameliorate?

"Ad-p53 is a common therapy for malignant neoplasms and has been found to be efficacious in treating unresectable melanoma, microsatellite instability high, and squamous cell carcinoma."

Answered by AI

Has the FDA sanctioned Ad-p53 for therapeutic application?

"Since Ad-p53 is still in Phase 2 of its clinical trial, the safety rating for this medication was assigned a score of 2. This signifies that while there have been collected evidence pointing to its security, no data exists yet demonstrating efficacy."

Answered by AI

What other research initiatives have been conducted on Ad-p53?

"The first trials of Ad-p53 were conducted in 2008 by SCRI Tennessee Oncology Chattanooga. There are now a total of 663 completed studies and 2281 active clinical investigations, with many taking place at the Morristown research centre in New jersey."

Answered by AI

What is the current capacity of this medical trial?

"Affirmative. Clinicaltrials.gov has data that verifies this clinical trial is actively looking for study participants, with its initial posting on October 1st 2018 and most recent update being June 5th 2020. The researchers need to enlist 40 individuals across 3 sites."

Answered by AI

Does this clinical experiment involve untested protocols?

"As of now, Ad-p53 is the subject of 2,281 active clinical trials spanning 79 countries and 4057 cities. Hoffmann-La Roche first ran a Phase 2 study in 2008 with 720 participants; since then, 663 additional experiments have taken place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of p53 Gene Therapy Combined With Immune Checkpoint Inhibitors in Solid Tumors.

2018. "Safety and Efficacy of p53 Gene Therapy Combined With Immune Checkpoint Inhibitors in Solid Tumors.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03544723.