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Virus Therapy
Oncolytic Virus + CAR T-Cell Therapy for Solid Cancers (VISTA Trial)
Phase 1
Recruiting
Led By Shalini Makawita, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 2 or less (Appendix I).
The patient must have at least one tumor site appropriate for intratumoral injection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
VISTA Trial Summary
This trial is testing the safety and effectiveness of two cancer treatments: CAdVEC, an oncolytic adenovirus that is designed to help the immune system, and HER2-specific CAR T cells.
Who is the study for?
Adults with advanced HER2 positive solid tumors, including breast, lung, and other cancers listed. They must have tried standard treatments without success or have no effective options left. Participants need to be in relatively good health (ECOG ≤ 2), not pregnant or breastfeeding, willing to use contraception, and have a tumor that can safely receive injections.Check my eligibility
What is being tested?
The trial is testing the combination of CAdVEC (an oncolytic virus injected into the tumor) with HER2-specific CAR T cells (immune cells designed to target cancer). The goal is to see if this combo is more effective than individual treatments by activating the immune system against cancer.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to immune therapies such as flu-like symptoms, fatigue, fever, and possible inflammation at injection sites. As it's an investigational treatment, there could also be unknown risks.
VISTA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but cannot do heavy physical work.
Select...
I have a tumor that can be injected directly.
Select...
My solid tumor is HER2 positive based on a test.
Select...
My liver tests are within the required limits.
Select...
My cancer is HER2 positive and includes types like breast or lung cancer.
Select...
My kidney function is within the normal range.
Select...
I am 18 or older and can understand and agree to the study's procedures.
VISTA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with dose limiting toxicity (DLT) by CTCAE 5.0
Secondary outcome measures
Disease Control Rate (DCR)
Number of treatment related adverse events with grade 3 or greater severity by CTCAE 5.0
Overall Response Rate (ORR) according to RECIST1.1 criteria
+2 moreVISTA Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment PhaseExperimental Treatment1 Intervention
Seven dose levels will be evaluated using the BOIN design. Cohorts of size 3 will be enrolled at each dose level until 9 evaluable patients have been studied at a single dose. Each patient will receive an intratumoral injection of CAdVEC alone or combined with an injection of HER2.CAR.T cells 3 days later (Day 4), according to the following dose levels.
Dose Level 1 CAdVEC = 5.00E+9 HER2 specific CAR-T cells = 0
Dose Level 2 CAdVEC = 1.00E+10 HER2 specific CAR-T cells = 0
Dose Level 3 CAdVEC = 1.00E+10 HER2 specific CAR-T cells = 1.00E+06
Dose Level 4 CAdVEC = 1.00E+11 HER2 specific CAR-T cells = 1.00E+06
Dose Level 5 CAdVEC = 1.00E+11 HER2 specific CAR-T cells = 1.00E+07
Dose Level 6 CAdVEC = 1.00E+12 HER2 specific CAR-T cells = 1.00E+07
Dose Level 7 CAdVEC = 1.00E+12 HER2 specific CAR-T cells = 1.00E+08
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,005 Previous Clinical Trials
6,003,253 Total Patients Enrolled
9 Trials studying Breast Cancer
1,626 Patients Enrolled for Breast Cancer
The Methodist Hospital Research InstituteOTHER
275 Previous Clinical Trials
80,500 Total Patients Enrolled
12 Trials studying Breast Cancer
306 Patients Enrolled for Breast Cancer
Shalini Makawita, MDPrincipal InvestigatorBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but cannot do heavy physical work.I have a tumor that can be injected directly.I had HER2 targeted therapy over 4 weeks ago.I have been diagnosed with HIV or another immune system disorder.I haven't had any cancer except for some skin, thyroid, prostate, or cervical cancers in the last 5 years.My cancer is considered untreatable with surgery, radiation, or medications by my oncologist.My organs are functioning well enough for treatment.I am on continuous medication for an autoimmune disease.My solid tumor is HER2 positive based on a test.My liver tests are within the required limits.I have had an organ transplant.I am not on any treatments that could interfere with the study, except possibly low-dose steroids or stable brain treatments.My tumor is in a location that could cause serious bleeding if injected.My cancer is HER2 positive and includes types like breast or lung cancer.You have a medical condition that weakens your immune system and makes it harder for your body to fight infections.There is a chance that the treatment may cause swelling in certain areas of your body that could block important passages, like your airway or digestive system.I do not have an active infection like hepatitis B or C.I had a heart attack within the last 6 months.My kidney function is within the normal range.My condition worsened after initial treatment or there are no effective treatments available.My heart's left ventricle is not pumping well.I am not pregnant and will use birth control during the study, or I cannot get pregnant.I am 18 or older and can understand and agree to the study's procedures.I agree to use barrier contraception to prevent pregnancy during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Phase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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