This study is a Phase 1/2 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV400. The study will enroll patients with relapsed/refractory B-cell malignancies, including large B-cell lymphoma (LBCL).
18 years or older
Provides voluntary written informed consent
Relapsed or refractory large B-cell lymphoma (LBCL)
Measurable disease according to Lugano 2014 criteria
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)
Sequential
UB-VV400
GeneticUB-VV400 is a gene therapy that generates CD22-directed CAR T cells in the body.
Rapamycin (sirolimus)
DrugRapamycin is a drug approved by the FDA for indications unrelated to cancer.
Phase 1: Percentage of participants with common adverse events (AEs)
Percentage of participants with commonly reported AEs overall and by severity
Phase 2: Overall response rate (ORR)
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)
Phase 1: Overall response rate (ORR)
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)
Phase 1 and Phase 2: Complete response rate (CRR)
Percentage of participants with a best overall response (BOR) of complete response (CR)
Phase 1 and Phase 2: Pharmacokinetics (PK) of UB-VV400
Maximum concentration (Cmax), time to maximum concentration (Tmax), and AUC (area under the concentration vs time curve) for UB-VV400
Phase 2: Percentage of participants with common AEs
Percentage of participants with commonly reported AEs overall and by severity
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