Lymphoma, B Cell, Lymphoma Non-Hodgkin, High Grade B Cell Lymphoma, Richter Transformation Lymphoma, Grade 3b Follicular Lymphoma, Primary Mediastinal B Cell Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL)
Conditions
Keywords
CAR T, chimeric antigen receptor, CD22
Brief summary
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).
Interventions
GENETICUB-VV400
UB-VV400 is a gene therapy that generates CD22-directed CAR T cells in the body.
Rapamycin is a drug approved by the FDA for indications unrelated to cancer.
Sponsors
Umoja Biopharma
Study design
Allocation
NA
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Percentage of participants with common adverse events (AEs) | Up to 2 years after UB-VV400 administration | Percentage of participants with commonly reported AEs overall and by severity |
| Phase 2: Overall response rate (ORR) | Up to 2 years after UB-VV4001 administration | Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Overall response rate (ORR) | Up to 2 years after UB-VV400 administration | 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) | Up to 2 years after UB-VV400 administration | Percentage of participants with a best overall response (BOR) of complete response (CR) |
| Phase 1 and Phase 2: Pharmacokinetics (PK) of UB-VV400 | Up to 8 days after UB-VV400 administration | 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 | Up to 2 years after UB-VV111 administration | Percentage of participants with commonly reported AEs overall and by severity |
| Phase 2: Duration of response (DOR) | Up to 2 years after UB-VV400 administration | Duration from first evidence of response (CR or PR) to date of first evidence of disease progression or death, whichever is earlier |
| Phase 2: Progression-free survival (PFS) | Up to 2 years after UB-VV400 administration | Duration from first administration of UB-VV400 to the first evidence of disease progression or death from any cause, whichever is earlier. |
| Phase 2: Overall survival (OS) | Up to 2 years after UB-VV400 administration | Duration from first administration of UB-VV400 to death from any cause |
| Phase 2: Quality of life (QOL) | Up to 2 years after UB-VV400 administration | Performance on 2 QoL scales: EuroQol instrument EQ-5D-5L and Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) |
Contacts
CONTACTLuke Walker, MD
CONTACTChristine Dehner
STUDY_DIRECTORLuke Walker, MD
Umoja Biopharma
Outcome results
None listed