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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 below
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I can take care of myself but cannot do heavy physical work.
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I have a tumor that can be injected directly.
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I had HER2 targeted therapy over 4 weeks ago.
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My cancer is considered untreatable with surgery, radiation, or medications by my oncologist.
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My organs are functioning well enough for treatment.
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My solid tumor is HER2 positive based on a test.
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My liver tests are within the required limits.
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My cancer is HER2 positive and includes types like breast or lung cancer.
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My kidney function is within the normal range.
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My condition worsened after initial treatment or there are no effective treatments available.
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I am not pregnant and will use birth control during the study, or I cannot get pregnant.
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I am 18 or older and can understand and agree to the study's procedures.
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I agree to use barrier contraception to prevent pregnancy during the study.

VISTA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

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 more

VISTA 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
999 Previous Clinical Trials
6,001,852 Total Patients Enrolled
9 Trials studying Breast Cancer
1,626 Patients Enrolled for Breast Cancer
The Methodist Hospital Research InstituteOTHER
270 Previous Clinical Trials
80,203 Total Patients Enrolled
12 Trials studying Breast Cancer
306 Patients Enrolled for Breast Cancer
Shalini Makawita, MDPrincipal InvestigatorBaylor College of Medicine

Media Library

CAdVEC (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03740256 — Phase 1
Breast Cancer Research Study Groups: Treatment Phase
Breast Cancer Clinical Trial 2023: CAdVEC Highlights & Side Effects. Trial Name: NCT03740256 — Phase 1
CAdVEC (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03740256 — Phase 1

Frequently Asked Questions

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

Is there still availability for individuals to join this research project?

"Based on the clinicaltrials.gov registry, this study is actively searching for eligible individuals to participate. The trial was initially posted on December 14th 2020 with its most recent update having been done August 24th 2022."

Answered by AI

Is CAdVEC a viable option for patients with regards to safety and efficacy?

"Our team at Power assigned a score of 1 to CAdVEC's safety due to its current status as a Phase 1 trial, implying that there is limited information on the drug's efficacy and risk profile."

Answered by AI

What is the aggregate patient count involved in this clinical research?

"Correct. The information on clinicaltrials.gov affirms that this trial, which was initially published on December 14th 2020, is presently accepting participants. 45 individuals need to be found from 1 medical centre."

Answered by AI
~8 spots leftby Dec 2024