Multiple Myeloma in RelapsePhase 1NCT07735546
A Phase 1 Study of UB-VV500 With Rapamycin in Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing UB-VV500 and Rapamycin (sirolimus) in people with Multiple Myeloma in Relapse and Multiple Myeloma (MM), run by Umoja Biopharma.
Trial summary
This study is a Phase 1 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV500. The study will enroll patients with relapsed/refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma in Relapse, Multiple Myeloma (MM)
- What is being tested?
- UB-VV500 and Rapamycin (sirolimus)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 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
- 18 years or older
- Provides voluntary written informed consent
- Relapsed or refractory multiple myeloma (MM) following treatment with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
- Measurable disease following completion of most recent anticancer therapy
- No serious concomitant diseases or active/uncontrolled infections
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
Who cannot join
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis
- Solitary plasmacytomas without evidence of systemic disease
- Women who are pregnant or breastfeeding
- Current isolated central nervous system (CNS) involvement
- Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor [TCR] fusion constructs, TCR T cells, and CAR T cells)
- History of or active human immunodeficiency virus (HIV)
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- Active or chronic hepatitis B, or active hepatitis C
- Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
- Ongoing CNS disease that would preclude neurologic assessment
- Uncontrolled angina or other acute heart disease
- Currently receiving treatment in another interventional clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Erin Mullane contact
About this study
Official title: A Phase 1, Open-label, Multicenter Study of UB-VV500 With Rapamycin in Relapsed or Refractory Multiple Myeloma
This study is a Phase 1 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV500. The study will enroll patients with relapsed/refractory multiple myeloma.
- Conditions
- Multiple Myeloma in Relapse, Multiple Myeloma (MM)
- Being tested
- UB-VV500, Rapamycin (sirolimus)
- Keywords
- CAR T, chimeric antigen receptor, BCMA, GPRC5D
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-VV500Genetic
UB-VV500 is a gene therapy that generates CAR T cells that target both B-cell maturation antigen (BCMA) and G protein-coupled receptor, family C, group 5, member D (GPRC5D) in the body.
Rapamycin (sirolimus)Drug
Rapamycin is a drug approved by the FDA for indications unrelated to cancer.
| Study group | Role | What they receive |
|---|---|---|
| UB-VV500 | Experimental | A single dose of UB-VV500 will be administered. Receives: Genetic: UB-VV500 |
| UB-VV500 + rapamycin | Experimental | A single dose of UB-VV500 will be administered followed by treatment with rapamycin. Receives: Genetic: UB-VV500; Drug: Rapamycin (sirolimus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with common adverse events (AEs)
Percentage of participants with commonly reported AEs overall and by severity
Measured: Up to 2 years after UB-VV500 administration
Secondary outcomes (1)
Overall response rate (ORR)
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)
Measured: Up to 2 years after UB-VV500 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 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 in RelapseStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umoja Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luke Walker, MD, Study director, Umoja Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735546
- Sponsor's protocol ID
- UB-VV500-01
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter Study of UB-VV500 With Rapamycin in Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07735546
- Acronym / sponsor ID
- UB-VV500-01
- Conditions
- Multiple Myeloma in Relapse, Multiple Myeloma (MM)
- Keywords
- CAR T, chimeric antigen receptor, BCMA, GPRC5D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Umoja BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Jul 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.
This study is a Phase 1 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV500. The study will enroll patients with relapsed/refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UB-VV500 | Experimental | Genetic: UB-VV500A single dose of UB-VV500 will be administered. |
| UB-VV500 + rapamycin | Experimental | Genetic: UB-VV500, Drug: Rapamycin (sirolimus)A single dose of UB-VV500 will be administered followed by treatment with rapamycin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- Provides voluntary written informed consent
- Relapsed or refractory multiple myeloma (MM) following treatment with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
- Measurable disease following completion of most recent anticancer therapy
- No serious concomitant diseases or active/uncontrolled infections
Key exclusion criteria (11 listed)
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis
- Solitary plasmacytomas without evidence of systemic disease
- Women who are pregnant or breastfeeding
- Current isolated central nervous system (CNS) involvement
- Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor [TCR] fusion constructs, TCR T cells, and CAR T cells)
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 |
|---|---|---|
| UB-VV500UB-VV500 is a gene therapy that generates CAR T cells that target both B-cell maturation antigen (BCMA) and G protein-coupled receptor, family C, group 5, member D (GPRC5D) in the body. | Genetic | UB-VV500, UB-VV500 + rapamycin |
| Rapamycin (sirolimus)Rapamycin is a drug approved by the FDA for indications unrelated to cancer. | Drug | UB-VV500 + rapamycin |
Primary outcome
Percentage of participants with common adverse events (AEs)
Time frame: Up to 2 years after UB-VV500 administration
Percentage of participants with commonly reported AEs overall and by severity
1 secondary outcome
Overall response rate (ORR)
Time frame: Up to 2 years after UB-VV500 administration
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 17 Aug 2026.
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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.
Erin Mullane contact
Luke Walker, MD study director
Umoja Biopharma
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UB-VV500 and Rapamycin (sirolimus) in people with Multiple Myeloma in Relapse and Multiple Myeloma (MM), run by Umoja Biopharma.
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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Luke Walker, MD (206-227-5056, luke.walker@umoja-biopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with common adverse events (AEs) (time frame: Up to 2 years after UB-VV500 administration). 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 17 Aug 2026.