40 Participants NeededMy employer runs this trial

VV169 for Multiple Myeloma

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VV169, which uses modified T-cells (a type of immune cell) to target multiple myeloma, a type of blood cancer. The goal is to determine the treatment's safety and understand its effects on patients whose cancer has returned or doesn't respond to standard treatments. The trial welcomes individuals who have undergone multiple myeloma treatments, particularly those whose cancer persists or recurs despite usual treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on HIV antiretroviral therapy, it may interfere with the trial treatment.

Is there any evidence suggesting that VV169 is likely to be safe for humans?

Research has shown that VV169, a new treatment for multiple myeloma, holds promise in early studies. In tests with mice, VV169 completely eliminated myeloma tumors within 28 days. While encouraging, results in animals don't always translate to humans.

In human studies, the treatment has generally been safe. Common side effects include infections, a decrease in blood cells, and mild to moderate cytokine release syndrome (CRS), an immune reaction. Although there are some risks, early testing has found the side effects manageable.

As a Phase 1 trial, the primary focus is on assessing safety and side effects in humans. While initial results are promising, further research is necessary to fully understand the safety of VV169 for people.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about VV169 for multiple myeloma because it offers a fresh approach to treating this cancer. Unlike standard treatments like proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies, VV169 is exploring new dosing strategies with its dose escalation and expansion phases. This could potentially lead to more personalized treatment plans, enhancing effectiveness while minimizing side effects. The innovative strategy behind VV169 may provide renewed hope for patients, especially those who have not responded to previous treatments.

What evidence suggests that VV169 might be an effective treatment for multiple myeloma?

Research has shown that VV169, a type of CAR T-cell therapy, could be promising for treating multiple myeloma. In a study with mice, researchers completely cleared myeloma tumors within 28 days after administering VV169. This outcome suggests that the treatment might also work well in humans. CAR T-cell therapies involve modifying a patient's T-cells (a type of immune cell) to help them attack cancer cells more effectively. Although human studies provide limited information, these early results offer hope for people with multiple myeloma that has returned or is not responding to other treatments. Participants in this trial will receive VV169, with some in the dose escalation phase for those with prior lines of treatment and others in the dose expansion phase for those with no prior lines of treatment.35678

Are You a Good Fit for This Trial?

This trial is for adults with multiple myeloma that has come back or hasn't responded to standard treatments. Participants must have already tried other therapies and still have active disease.

Inclusion Criteria

I have tumors that can be measured by scans or exams.
Able and willing to sign the informed consent form and comply with the protocol and the restrictions and assessments therein
I have multiple myeloma that has returned or not responded after at least 3 treatments, or I cannot receive standard treatments.
See 7 more

Exclusion Criteria

I have a plasma cell disorder like MGUS, smoldering myeloma, or amyloidosis.
I do not have another cancer needing treatment, except for early or low-risk cancers.
My multiple myeloma has spread to my brain or spinal cord and is not controlled.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Eligible patients receive VV169 to determine the maximum tolerated dose

28 days

Dose Expansion

Additional patients receive VV169 at the optimal dose identified in the escalation phase

Variable, until progressive disease or start of next treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • VV169

Trial Overview

The study is testing VV169, a new gene therapy that uses a virus to deliver CAR T-cell instructions directly into the body. Patients receive an infusion and are closely monitored for safety over up to two years.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Active relapsed or refractory multiple myeloma with prior lines of treatmentExperimental Treatment1 Intervention
Group II: Active relapsed or refractory multiple myeloma with no prior lines of treatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vyriad, Inc.

Lead Sponsor

Trials
6
Recruited
290+

Mayo Clinic

Collaborator

Trials
3,427
Recruited
3,221,000+

Citations

Real-world treatment patterns and outcomes in relapsed ...

Outcomes remain suboptimal, despite greater use of newer combination therapies, highlighting the need for early use of novel treatments. Overall, 34.8% of ...

Vyriad Unveils Lead In Vivo CAR T Candidate VV169 and ...

100% of mice treated with a single intravenous dose of VV169 saw complete clearance of disseminated myeloma tumors within 28 days ...

Treatment of relapsed and refractory multiple myeloma

In first relapse clinically relevant responses can be achieved in 40 – 50% of patients. An important question is whether the depth of response ...

What Is the Life Expectancy With Relapsed/Refractory ...

In one study of nearly 13,000 people with relapsed/refractory half were still alive 32.4 months. Over 90 percent of people respond well to ...

Linker-MM1 Study: Linvoseltamab in Refractory Myeloma

The initial findings showed promising results in terms of efficacy and manageable safety. In this report, researchers provide further analysis,

Relapsed/Refractory Multiple Myeloma: A Review of Available ...

The drug was also considered safe, with common toxicities being infections and cytopenias and Grade 1–2 CRS [110]. Larger phase trials are ...

A Phase 1 Dose-escalation and Expansion Study of In Vivo ...

A Phase 1, first in human, study to evaluate the safety and the effects of in vivo BCMA-CAR T cell therapy (VV169) in patients with Multiple ...

Vyriad targets 2026 clinical trial for experimental therapy ...

According to Vyriad, safety data showed the treatment was well tolerated in the mice. Discuss. Share. Share this page with email Share this ...