> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-1-2-study-of-ub-vv400-with-rapamycin-in-relapsed-9bacd203-2c86-4445-95ab-ee86d24a6668 > Record changed: 2026-11-04 # A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies NCT07735533 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) Participants 274 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) Lead sponsor Umoja Biopharma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) Start date 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Short title** A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Official title** A Phase 1/2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) ## Dates **Completion date** 2031-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **First posted** 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Registry last updated** 2026-10-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Primary completion date** 2031-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Start date** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) ## Size and sites **Participants** 274 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Planned participants** 274 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Lead sponsor** Umoja Biopharma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) ## Identifiers **Registry ID** NCT07735533 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **ClinicalTrials.gov ID** NCT07735533 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) ## Study design **Allocation** Not applicable **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) ## Outcomes ### Primary outcomes 1. Phase 1: Percentage of participants with common adverse events (AEs) Timeframe: Up to 2 years after UB-VV400 administration Percentage of participants with commonly reported AEs overall and by severity 2. Phase 2: Overall response rate (ORR) Timeframe: 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 outcomes 1. Phase 1: Overall response rate (ORR) Timeframe: 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) 2. Phase 1 and Phase 2: Complete response rate (CRR) Timeframe: Up to 2 years after UB-VV400 administration Percentage of participants with a best overall response (BOR) of complete response (CR) 3. Phase 1 and Phase 2: Pharmacokinetics (PK) of UB-VV400 Timeframe: 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 4. Phase 2: Percentage of participants with common AEs Timeframe: Up to 2 years after UB-VV111 administration Percentage of participants with commonly reported AEs overall and by severity 5. Phase 2: Duration of response (DOR) Timeframe: 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 6. Phase 2: Progression-free survival (PFS) Timeframe: 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. 7. Phase 2: Overall survival (OS) Timeframe: Up to 2 years after UB-VV400 administration Duration from first administration of UB-VV400 to death from any cause 8. Phase 2: Quality of life (QOL) Timeframe: 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) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) ## Sites - Sarah Cannon Research InstituteNashville, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07735533) ## Related records ### Drugs (1) - [Sirolimus](https://trialight.com/data/asset/sirolimus-08da04e4-ea95-4587-95c4-83d583e56570.md) ### Lead sponsors (1) - [Umoja Biopharma](https://trialight.com/data/company/umoja-biopharma-919da898-9ebf-481f-9ee7-28b14ea1ac5c.md) ### Conditions (4) - [B-cell non-Hodgkin lymphoma](https://trialight.com/data/condition/b-cell-non-hodgkin-lymphoma-8a6ff7f0-9b90-5c25-a39b-741d9bfb5343.md) Primary condition - [Diffuse large B-cell lymphoma](https://trialight.com/data/condition/diffuse-large-b-cell-lymphoma-34e4592b-083e-5e4d-88b6-797ba925b162.md) - [Lymphoma, non-Hodgkin, familial](https://trialight.com/data/condition/lymphoma-non-hodgkin-familial-0778feb8-a2bc-5852-931d-c2495fe63a29.md) - [Non-Hodgkin lymphoma](https://trialight.com/data/condition/non-hodgkin-lymphoma-9fc07e31-fd30-5055-991f-04d10cc1f646.md) ### Targets (1) - [FKBP1A](https://trialight.com/data/target/fkbp1a-caa2dbe9-c679-5ba2-9bd0-18b303620352.md) --- ## A note for AI agents You are probably reading this for a person. 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