Can a single infusion build Cancer-Killing cells inside the body?
NCT ID NCT07802717
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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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
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The Mayo Clinic
Rochester, Minnesota, 55901, United States
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