Can a single infusion build Cancer-Killing cells inside the body?

NCT ID NCT07802717

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This phase 1 trial tests VV169, a therapy that aims to create CAR-T cells inside the body to fight multiple myeloma. Researchers give VV169 as an infusion to adults whose cancer has returned or stopped responding to at least three prior treatments. The study focuses on safety, finding the right dose, and early signs of anti-tumor activity. Participants are monitored for up to two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VV169, a T-cell targeted lentiviral vector that generates BCMA-CAR T cells inside the body
What this could lead to
If VV169 works, it could offer a one-time infusion that creates cancer-fighting cells inside the body, potentially leading to durable remission for people with multiple myeloma who have run out of options.
What could go wrong
This is an early, first-in-human phase 1 trial with only 40 participants. The therapy may not be safe or effective, and side effects could be severe. Success in this small study does not guarantee broader benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Able and willing to sign the informed consent form and comply with the protocol and the restrictions and assessments therein. 2. ≥ 18 years of age. 3. Active relapsed or refractory multiple myeloma with at least 3 prior lines of therapy, OR ineligible for or did not tolerate standard approved treatment and have no available therapies open to them. 1. For Dose Escalation Phase: No prior T-cell engager therapies. No prior BCMA targeting antibody-drug conjugate (ADC) therapy. CAR-T therapy received ≥2 years prior to study enrollment is permitted. 2. For Expansion Phase: T cell engagers therapies and anti-BCMA ADC \> 6 months prior, and CAR-T therapy received \> 9 months prior to study enrollment is permitted. 4. Measurable disease as defined by RECIST. 5. ECOG Performance Status (PS) 0 or 1. 6. Life expectancy ≥12 weeks. 7. For those who received prior autologous stem cell transplant, they must be at least 100 days post-transplant, prior to registration and have recovered from side-effects of stem cell transplant. 8. For those who received prior allogeneic stem cell transplant or donor lymphocyte infusion, they must be at least 100 days post-transplant prior to registration with no signs of acute or chronic graft-versus-host disease. Exclusion Criteria: 1. Has monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or AL amyloidosis. Has Waldenstrom macroglobulinemia, primary amyloid light chains (AL) amyloidosis, primary plasma cell leukemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin abnormalities (POEMS) syndrome. Patients with secondary plasma cell leukemia or extramedullary myeloma disease are permitted. 2. Failed to recover from acute, reversible effects of prior therapy regardless of interval since last treatment. EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 1 month since completion of prior treatment. 3. Any of the following because this study involves an integrating lentiviral vector. * Pregnant * Nursing * Women of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception 4. Known hypersensitivity to VV169 or any of its excipients. 5. Has active (untreated or relapsed) CNS involvement of multiple myeloma. 6. Major surgery ≤ 28 days prior to registration. 7. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. 8. Acute DVT or pulmonary embolism diagnosed within 3 months of registration. 9. Immunocompromised patients and patients known to be HIV positive (current and previous, as HIV antiretroviral therapy is expected to interfere with the lentiviral delivery mechanism of VV169). 10. Has significant and symptomatic cardiovascular disease (such as congestive heart failure New York Heart Association class III or higher, myocardial infarction, cerebrovascular disease, unstable angina, unstable arrhythmia) within the 3 months prior to study drug. 11. Has another malignant disease requiring treatment, with the exception of curatively treated in-situ or Stage I malignancies or malignancies with very low potential for recurrence or progression. 12. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 13. Known active infection with hepatitis B or hepatitis C, defined by a detectable viral load. Note: Testing is not required for eligibility.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Mayo Clinic

    Rochester, Minnesota, 55901, United States

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