Multiple Myeloma in Relapse, Multiple Myeloma (MM)
Conditions
Keywords
CAR T, chimeric antigen receptor, BCMA, GPRC5D
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.
Interventions
GENETICUB-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.
Rapamycin is a drug approved by the FDA for indications unrelated to cancer.
Sponsors
Umoja Biopharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Contacts
CONTACTLuke Walker, MD
CONTACTErin Mullane
STUDY_DIRECTORLuke Walker, MD
Umoja Biopharma
Outcome results
None listed