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Not yet recruiting NCT07735546

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

Phase I Interventional Multiple Myeloma in Relapse Multiple Myeloma (MM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UB-VV500, Rapamycin (sirolimus).
Who it may be relevant to
Registry conditions: Multiple Myeloma in Relapse, Multiple Myeloma (MM). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Genetic UB-VV500
    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.
  • Drug Rapamycin (sirolimus)
    Rapamycin is a drug approved by the FDA for indications unrelated to cancer.

Primary outcome measures

  • Percentage of participants with common adverse events (AEs) [Time frame: Up to 2 years after UB-VV500 administration]
Secondary outcome measures (1)
  • Overall response rate (ORR) [Time frame: Up to 2 years after UB-VV500 administration]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07735546 · UB-VV500-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗