← Back to Search

CAR T-cell Therapy

CAR T-Cells + CMV-MVA Triplex Vaccine for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Led By Leslie L Popplewell

Research Sponsored by City of Hope Medical Center

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 time from the start of lymphodepletion to the time of disease relapse, progression or death, whichever occurs first, assessed at 1 year and up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests CAR T cells & CMV-MVA triplex vaccine to treat relapsed/refractory NHL. CAR T cells are changed to attack cancer cells & vaccine helps body build immune response to kill cancer.

Who is the study for?

Adults with relapsed or refractory B-cell non-Hodgkin lymphoma, who are CMV seropositive and have a life expectancy of at least 16 weeks. They must be in good physical condition (KPS >= 70), not pregnant, willing to use birth control, and without significant heart, liver or kidney issues. Excluded are those with active autoimmune disease on treatment, recent allogeneic stem cell transplant recipients, or anyone on investigational agents.

What is being tested?

The trial is testing genetically modified T-cells targeting CD19 on cancer cells plus a CMV-based vaccine after chemotherapy that reduces immune cells (lymphodepletion). It aims to see if this combination can help the body's immune system fight the lymphoma more effectively.

What are the potential side effects?

Potential side effects include reactions related to the infusion of T-cells such as fever and chills; organ inflammation due to an overactive immune response; blood count changes; fatigue; risk of infection from weakened immunity post-chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from the start of lymphodepletion to the time of disease relapse, progression or death, whichever occurs first, assessed at 1 year and up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from the start of lymphodepletion to the time of disease relapse, progression or death, whichever occurs first, assessed at 1 year and up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the start of lymphodepletion to the time of disease relapse, progression or death, whichever occurs first, assessed at 1 year and up to 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

Incidence of adverse events

Incidence of dose-limiting toxicity

Secondary study objectives

Clinically significant CMV reactivation

Disease response (complete response/minor response/partial response/disease progression/stable disease)

Feasibility as assessed by the ability to meet the required cell dose and product release requirement

+3 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 (CMV-specific CD19-CAR T cells, triplex vaccine)Experimental Treatment10 Interventions

Patients undergo leukapheresis on day -30 and receive lymphodepleting chemotherapy on days -10 to -3 per SOC on study. Patients then receive CMV-specific CD19-CAR T cells IV on day 0 and CMV-MVA triplex vaccine IM on days 28 and 56 in the absence of unacceptable toxicity on study. Patients also undergo x-ray during screening and on study, as well as PET, CT, MRI, blood sample collection, and bone marrow biopsy on study and during follow-up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Bone Marrow Biopsy

2021

Completed Phase 3

~230