Multiple Myeloma RefractoryPhase 1NCT07802717
A Phase 1 Dose-escalation and Expansion Study of In Vivo BCMA-CAR T Cell Therapy (VV169) in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing VV169 in people with Multiple Myeloma Refractory and Multiple Myeloma in Relapse, run by Vyriad, Inc. at 1 site in United States.
Trial summary
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 Myeloma that has been previously treated and has come back, or does not respond to standard treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma Refractory, Multiple Myeloma in Relapse
- What is being tested?
- VV169
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2026to 31 Aug 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to sign the informed consent form and comply with the protocol and the restrictions and assessments therein.
- ≥ 18 years of age.
- 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.
- 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.
- 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.
- Measurable disease as defined by RECIST.
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- ECOG Performance Status (PS) 0 or 1.
- Life expectancy ≥12 weeks.
- 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.
- 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.
Who cannot join
- 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.
- 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.
- Any of the following because this study involves an integrating lentiviral vector.
- Pregnant
- Nursing
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- Women of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
- Known hypersensitivity to VV169 or any of its excipients.
- Has active (untreated or relapsed) CNS involvement of multiple myeloma.
- Major surgery ≤ 28 days prior to registration.
- 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.
- Acute DVT or pulmonary embolism diagnosed within 3 months of registration.
- 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).
- 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.
- 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.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Known active infection with hepatitis B or hepatitis C, defined by a detectable viral load. Note: Testing is not required for eligibility.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Mayo Clinic
Rochester, Minnesota, 55901
Yi Lin, MD, 855-776-0015, mayocliniccancerstudies@mayo.edu
Yi Lin, MD
About this study
Official title: A Phase 1 Dose-escalation and Expansion Study to Evaluate Safety, Pharmacodynamics and Preliminary Efficacy of VV169 in Patients With Relapsed or Refractory Multiple Myeloma
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 Myeloma that has been previously treated and has come back, or does not respond to standard treatments. Eligible patients will receive VV169, a T-cell targeted lentiviral vector, via infusion. Patients will be monitored for safety and tolerability for up to 2 years, until progressive disease or start of next treatment, whichever is earlier.
Read the detailed description
Eligible patients will be recruited into either the dose escalation phase or dose expansion phase. Eligible patients will be adults who have received prior therapy, or are ineligible for, or did not tolerate standard approved treatment and have no available therapies open to them are eligible.
Additional patients will be recruited in the expansion phase once an optimal dose has been identified. In the expansion phase, T cell engagers therapies and anti-BCMA ADC > 6 months prior, and CAR-T therapy received > 9 months prior to study enrollment will be permitted.
- Being tested
- VV169
- Keywords
- CAR-T, BCMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VV169Biological
T-cell Targeted (CD3- targeted lentiviral vector)
| Study group | Role | What they receive |
|---|---|---|
| Active relapsed or refractory multiple myeloma with prior lines of treatment | Experimental | Dose Escalation Receives: Biological: VV169 |
| Active relapsed or refractory multiple myeloma with no prior lines of treatment | Experimental | Dose Expansion Receives: Biological: VV169 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of VV169 and determine the maximum tolerated dose
Assess incidence, type and severity of AEs, SAEs, DLTs, and clinically relevant laboratory abnormalities.
Measured: 2 years
Determine the recommended phase 2 dose of VV169
Incidence of DLTs and SAEs per dose level in dose escalation phase.
Measured: 28 days post last patient last dose in the Dose Escalation phase.
Secondary outcomes (1)
Anti-tumor activity of the in vivo generated BCMA+ CAR-T cells
Objective Response Rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start8 Sep 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma RefractoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vyriad, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802717
- Sponsor's protocol ID
- VYR-VV169-101 (MC260802)
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-escalation and Expansion Study to Evaluate Safety, Pharmacodynamics and Preliminary Efficacy of VV169 in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07802717
- Acronym / sponsor ID
- VYR-VV169-101 (MC260802)
- Keywords
- CAR-T, BCMA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vyriad, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Myeloma that has been previously treated and has come back, or does not respond to standard treatments. Eligible patients will receive VV169, a T-cell targeted lentiviral vector, via infusion. Patients will be monitored for safety and tolerability for up to 2 years, until progressive disease or start of next treatment, whichever is earlier.
Detailed description
Eligible patients will be recruited into either the dose escalation phase or dose expansion phase. Eligible patients will be adults who have received prior therapy, or are ineligible for, or did not tolerate standard approved treatment and have no available therapies open to them are eligible.
Additional patients will be recruited in the expansion phase once an optimal dose has been identified. In the expansion phase, T cell engagers therapies and anti-BCMA ADC > 6 months prior, and CAR-T therapy received > 9 months prior to study enrollment will be permitted.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active relapsed or refractory multiple myeloma with prior lines of treatment | Experimental | Biological: VV169Dose Escalation |
| Active relapsed or refractory multiple myeloma with no prior lines of treatment | Experimental | Biological: VV169Dose Expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able and willing to sign the informed consent form and comply with the protocol and the restrictions and assessments therein.
- ≥ 18 years of age.
- 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.
- Measurable disease as defined by RECIST.
- ECOG Performance Status (PS) 0 or 1.
Key exclusion criteria (17 listed)
- 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.
- 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.
- Any of the following because this study involves an integrating lentiviral vector.
- Known hypersensitivity to VV169 or any of its excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VV169T-cell Targeted (CD3- targeted lentiviral vector) | Biological | Active relapsed or refractory multiple myeloma with no prior lines of treatment, Active relapsed or refractory multiple myeloma with prior lines of treatment |
Primary outcome
Safety and tolerability of VV169 and determine the maximum tolerated dose
Time frame: 2 years
Assess incidence, type and severity of AEs, SAEs, DLTs, and clinically relevant laboratory abnormalities.
Determine the recommended phase 2 dose of VV169
Time frame: 28 days post last patient last dose in the Dose Escalation phase.
Incidence of DLTs and SAEs per dose level in dose escalation phase.
1 secondary outcome
Anti-tumor activity of the in vivo generated BCMA+ CAR-T cells
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VV169 in people with Multiple Myeloma Refractory and Multiple Myeloma in Relapse, run by Vyriad, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of VV169 and determine the maximum tolerated dose (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.