Clinical trial · Interventional
A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies
A Phase 1/2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies
NCT07735533CI-TRIAL-00122286not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Grade 3b Follicular Lymphoma | Grade 3b Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| High Grade B Cell Lymphoma | High Grade B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Lymphoma, B Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Lymphoma Non-Hodgkin | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Primary Mediastinal B Cell Lymphoma | Primary Mediastinal Large B-Cell Lymphoma | ALIAS | 0.90 |
| Richter Transformation Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rapamycin (sirolimus) | Drug | Sirolimus | ALIAS |
| UB-VV400 | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- UB-VV400 + rapamycin
- description
- A single dose of UB-VV400 will be administered followed by treatment with rapamycin.
- interventionNames
- Genetic: UB-VV400
- Drug: Rapamycin (sirolimus)
Primary outcomes (2)
- measure
- Phase 1: Percentage of participants with common adverse events (AEs)
- timeFrame
- Up to 2 years after UB-VV400 administration
- description
- Percentage of participants with commonly reported AEs overall and by severity
- measure
- Phase 2: Overall response rate (ORR)
- timeFrame
- Up to 2 years after UB-VV4001 administration
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.