A Phase 1 Study of UB-VV500 With Rapamycin in Relapsed/Refractory Multiple Myeloma

NCT07735546 — Phase 1, Not yet recruiting, 100 participants, Umoja Biopharma

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A Phase 1, Open-label, Multicenter Study of UB-VV500 With Rapamycin in Relapsed or Refractory Multiple Myeloma

Registry	NCT07735546
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; non randomized, sequential, masking: none, treatment
Enrollment	100 (Estimated)
Sponsor	Umoja Biopharma (Industry)
Conditions	Multiple Myeloma in Relapse, Multiple Myeloma (MM)
Interventions	UB-VV500, Rapamycin (sirolimus) (Genetic, drug)
Dates	start 2026-10-01 (estimated), primary completion 2029-12-31 (estimated), completion 2029-12-31 (estimated), first posted 2026-07-30, last updated 2026-08-17

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
UB-VV500	Experimental	Genetic: UB-VV500	A 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.

UB-VV500 (Genetic): 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.

+Outcome measures

Primary outcomes

Percentage of participants with common adverse events (AEs) [Up to 2 years after UB-VV500 administration]: Percentage of participants with commonly reported AEs overall and by severity

Secondary outcomes

Overall response rate (ORR) [Up to 2 years after UB-VV500 administration]: Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Investigators

Luke Walker, MD, Study director, Umoja Biopharma