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Monoclonal Antibodies

Modified Virus and Immunotherapy for T-Cell Lymphoma

Phase 1

Recruiting

Led By Kah Whye Peng, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Relapsed or refractory Group E only: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); anaplastic large cell (ALCL), and mycosis fungoides (MF)

Age ≥ 18 years

Must not have

Active CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology; in case of AML active CNS involvement as detected by lumbar puncture or neuro-imaging (only to be done if clinically indicated)

Uncontrolled infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a modified virus called VSV-hIFNβ-NIS along with two immunotherapy drugs, ipilimumab and cemiplimab, in patients with T-cell lymph

Who is the study for?

This trial is for patients with various types of T-cell lymphoma, including peripheral T-cell lymphoma and skin lymphomas. Participants should not have a fungal infection or mouth sores. The full eligibility criteria are not provided, but typically include factors like age, health status, and prior treatments.

What is being tested?

The trial is testing a genetically modified virus (VSV-hIFNβ-NIS) that may target cancer cells without harming normal ones. It's used alongside ipilimumab and cemiplimab—two immunotherapy drugs—to see if they can help the immune system fight the cancer more effectively.

What are the potential side effects?

Potential side effects might include typical reactions to viruses such as fever or fatigue, as well as immune-related responses due to ipilimumab and cemiplimab which could range from mild skin reactions to more serious conditions affecting organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma has returned or didn't respond to treatment and is one of the specified types.

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I am 18 years old or older.

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I have a tumor larger than 2 cm or cancer cells in my blood, confirmed by scans.

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I can take care of myself and am up and about more than half of the day.

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My brain and spinal cord are free from cancer.

Exclusion Criteria

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

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I do not have an active brain disorder or symptoms affecting my nervous system.

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I do not have any infections that are currently untreated or not under control.

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I do not have active tuberculosis or hepatitis.

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I haven't had chemotherapy, immunotherapy, or experimental treatments for AML or TCL within the specified time before signing up.

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I have severe heart issues, including heart failure or irregular heartbeat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Incidence of adverse events of grade 3 or higher

Secondary study objectives

Clinical response

Overall survival (OS)

Progression-free survival (PFS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - Peripheral T-cell lymphoma (PTCL) onlyExperimental Treatment9 Interventions

PTCL patients receive VSV-IFNβ-NIS IV over 30 minutes on day 1, ipilimumab IV over 30 minutes on day -3 and cemiplimab IV over 30 minutes on day -3 in the absence of disease progression or unacceptable toxicity. Patients undergo SPECT, CT scan, PET scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.

Group II: Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - PTCL Expansion CohortExperimental Treatment9 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1470

Ipilimumab

2015

Completed Phase 3