๐ฌIn plain words
What the trial is, and whether it could suit you
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).
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. 18 years or older
2. Provides voluntary written informed consent
3. Relapsed or refractory large B-cell lymphoma (LBCL)
4. Measurable disease according to Lugano 2014 criteria
5. Confirmed CD22 expression
6. No serious concomitant diseases or active/uncontrolled infections
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
8. Adequate organ function
Exclusion Criteria:
1. Women who are pregnant or breastfeeding
2. Current isolated central nervous system (CNS) involvement
3. 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)
4. History of or active human immunodeficiency virus (HIV)
5. Active or chronic hepatitis B, or active hepatitis C
6. Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
7. Ongoing CNS disease that would preclude neurologic assessment
8. Uncontrolled angina or other acute heart disease
9. Currently receiving treatment in another interventional clinical trial.
๐
What it tests
- UB-VV400
- Rapamycin (sirolimus)
Sarah Cannon Research Institute
Nashville, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.