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Can a single gene therapy turn the body into a Cancer-Fighting factory?

NCT ID NCT07735546

Cure Sponsor: Umoja Biopharma Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This phase 1 trial is testing a new gene therapy called UB-VV500 for people with multiple myeloma that has returned or stopped responding to treatment. The therapy works by giving the body genetic instructions to produce its own CAR T cells that target two proteins on myeloma cells. Participants also receive rapamycin, a drug that may help the engineered cells work better. The study aims to find the safest dose and see whether this approach can shrink tumors.

What this could mean

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

Active substance
a gene therapy called UB-VV500 that instructs the body to make its own CAR T cells targeting two myeloma proteins, plus the drug rapamycin
What this could lead to
If it works, this could offer a new treatment option for people with multiple myeloma that has stopped responding to standard therapies.
What could go wrong
This is an early phase 1 trial, so safety and effectiveness are not yet known. Gene therapies can cause serious side effects, and the approach may not work for everyone.

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 100 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 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. 18 years or older 2. Provides voluntary written informed consent 3. Relapsed or refractory multiple myeloma (MM) following treatment with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody 4. Measurable disease following completion of most recent anticancer therapy 5. No serious concomitant diseases or active/uncontrolled infections 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Adequate organ function Exclusion Criteria: 1. Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis 2. Solitary plasmacytomas without evidence of systemic disease 3. Women who are pregnant or breastfeeding 4. Current isolated central nervous system (CNS) involvement 5. 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) 6. History of or active human immunodeficiency virus (HIV) 7. Active or chronic hepatitis B, or active hepatitis C 8. Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease 9. Ongoing CNS disease that would preclude neurologic assessment 10. Uncontrolled angina or other acute heart disease 11. Currently receiving treatment in another interventional clinical trial.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma (MM) Multiple myeloma in relapse

How to take part

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

  1. The official record

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

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.