NCT07735546

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
40mo left

Started Oct 2026

Typical duration for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

3.3 years

First QC Date

July 24, 2026

Last Update Submit

July 24, 2026

Conditions

Multiple Myeloma in RelapseMultiple Myeloma (MM)

Keywords

CAR Tchimeric antigen receptorBCMAGPRC5D

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants with common adverse events (AEs)

    Percentage of participants with commonly reported AEs overall and by severity

    Up to 2 years after UB-VV500 administration

Secondary Outcomes (1)

  • Overall response rate (ORR)

    Up to 2 years after UB-VV500 administration

Study Arms (2)

UB-VV500

EXPERIMENTAL

A single dose of UB-VV500 will be administered.

Genetic: UB-VV500

UB-VV500 + rapamycin

EXPERIMENTAL

A single dose of UB-VV500 will be administered followed by treatment with rapamycin.

Genetic: UB-VV500Drug: Rapamycin (sirolimus)

Interventions

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.

UB-VV500UB-VV500 + rapamycin
Rapamycin (sirolimus)DRUG

Rapamycin is a drug approved by the FDA for indications unrelated to cancer.

UB-VV500 + rapamycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Jacob Garcia, MD

    Umoja Biopharma

    STUDY DIRECTOR

Central Study Contacts

Jacob Garcia, MD

CONTACT

425-873-8331jacob.garcia@umoja-biopharma.com

Erin Mullane

CONTACT

erin.mullane@umoja-biopharma.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 30, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

July 30, 2026

Record last verified: 2026-07