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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.

Must not have

Diagnosis of HIV or other immunodeficiency disorders.

History or evidence of active autoimmune disease requiring continuous systemic corticosteroids, immunosuppressants or other disease modifying agents.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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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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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I am 18 or older and can understand and agree to the study's procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with HIV or another immune system disorder.

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I am on continuous medication for an autoimmune disease.

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I have had an organ transplant.

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My tumor is in a location that could cause serious bleeding if injected.

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I do not have an active infection like hepatitis B or C.

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My heart's left ventricle is not pumping well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with dose limiting toxicity (DLT) by CTCAE 5.0

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 13Eligibility criteria met