Actively Recruiting
UB-VV400 in Combination With Rapamycin in Relapsed or Refractory B-cell Malignancies
Led by Nanjing IASO Biotechnology Co., Ltd. · Updated on 2025-09-18
70
Participants Needed
2
Research Sites
276 weeks
Total Duration
On this page
Sponsors
N
Nanjing IASO Biotechnology Co., Ltd.
Lead Sponsor
T
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an exploratory, open-label, investigator-initiated trial (IIT) of the safety, efficacy, and PK/Pd of UB-VV400 alone and in combination with rapamycin in adult subjects with R/R LBCL. LBCL will include subjects with aggressive lymphoma, defined as diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), including high-grade lymphoma (HGL) with double/triple hit DLBCL; transformed DLBCL (tDLBCL), including Richter's transformation; follicular lymphoma Grade 3B (FL3B); and primary mediastinal B-cell lymphoma (PMBCL). The study will include subjects who have had prior CD19-directed CAR T-cell exposure and subjects who are CAR T cell-naive. Clinical unmet need exists in both populations. The objective of this study is to determine the MTD/MAD and following study of UB-VV400 administered alone and in combination with rapamycin. The dose-finding (DF) portion will evaluate the safety profile of UB-VV400 administered at various dose levels (DLs) alone (Stage 1) and in combination with rapamycin (Stage 2). The dose-expansion (DE) portion will further optimize the dose and define the safety profile and preliminary efficacy of UB-VV400 alone and/or in combination with rapamycin. The study will use the Bayesian optimal interval (BOIN) design to allocate subjects to various DLs to minimize exposure to subtherapeutic DLs while maintaining appropriate safety parameters. DF will consist of 2 stages: Stage 1 DF aims to identify the MTD of UB-VV400 monotherapy, and Stage 2 DF aims to identify the MTD of UB-VV400 in combination with rapamycin. DF will be initiated in Stage 1 with UB-VV400 monotherapy, administered IV and starting at DL1.
CONDITIONS
Official Title
UB-VV400 in Combination With Rapamycin in Relapsed or Refractory B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Provide voluntary written informed consent
- Have relapsed or refractory disease and be either CAR T-cell therapy naive or previously exposed
- Have measurable disease according to Lugano 2014 criteria
- No serious concomitant diseases or active uncontrolled infections
- ECOG performance status of 0 or 1
- Left ventricular ejection fraction (LVEF) of 40% or higher
- Pulse oximetry reading of 90% or higher on room air at rest
- Serum creatinine less than or equal to 1.5 times age-adjusted upper limit of normal or creatinine clearance of 45 mL/min or higher
- Absolute lymphocyte count of 0.2 x 10^9/L or higher
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 times upper limit of normal, and total bilirubin less than 1.5 times upper limit of normal
- No ongoing coagulopathies requiring clotting factor replacement
- Women of childbearing potential must have two negative pregnancy tests and agree to abstinence or use highly effective contraception for 12 months after UB-VV400 treatment and abstain from breastfeeding for 12 months
- Men with partners of childbearing potential must agree to abstain or use highly effective contraception for 12 months after treatment
- Agree not to donate blood, organs, sperm/semen, or egg cells for at least 1 year after treatment
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Current isolated central nervous system tumor involvement
- Prior malignancy with potential to interfere with safety or efficacy evaluation
- Prior treatment with allogeneic bone marrow transplantation, gene therapy, or adoptive cell transfer except CAR T-cell therapy
- Prior CD22-directed therapy except UB-VV400
- History or active infection with HIV
- Active hepatitis B or C infection
- For those receiving rapamycin: history of angioedema or grade 3 or greater pneumonitis
- Ongoing grade greater than 2 toxicities from prior anticancer therapy
- Recent use of high-dose corticosteroids, approved targeted therapies, autologous stem cell transplant, cytotoxic chemotherapy, experimental agents, immune-suppressing agents, radiation, or antiretroviral prophylaxis within specified time frames before UB-VV400 dosing
- Allergies to rapamycin or supportive medications for CAR T-cell toxicity management
- Systemic autoimmune or immunodeficiency diseases except well-controlled type I diabetes or thyroid disease
- Ongoing central nervous system diseases that interfere with neurotoxicity evaluation
- Uncontrolled heart disease or recent serious cardiac events
- Actively receiving treatment in other interventional clinical trials (follow-up allowed without investigational agents or assessments)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
Actively Recruiting
2
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China
Not Yet Recruiting
Research Team
C
Changpu Cao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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