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

ConditionsMultiple Myeloma in Relapse Multiple Myeloma (MM)

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorUmoja Biopharma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: UB-VV500Experimental treatment 1 intervention

Group B: UB-VV500 + rapamycinExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Percentage of participants with common adverse events (AEs)

Percentage of participants with commonly reported AEs overall and by severity

Time frame

Up to 2 years after UB-VV500 administration

Secondary outcomes

Overall response rate (ORR)

Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)

Time frame

Up to 2 years after UB-VV500 administration

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Umoja Biopharma

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: