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Large B-cell LymphomaPhase 1NCT06743503

UB-VV400 in Combination With Rapamycin in Relapsed or Refractory B-cell Malignancies

A Phase 1 study testing UB-VV400 and Rapamycin in people with Large B-cell Lymphoma, run by Nanjing IASO Biotechnology Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Large B-cell Lymphoma
What is being tested?
UB-VV400 and Rapamycin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
2 sitesChina
Study dates
11 Apr 2025to 31 Jul 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 at time of consent.
  • Provide voluntary written informed consent.
  • Relapsed/refractory disease for subjects that are either CAR T-naive or CAR T-exposed.
  • Measurable disease according to Lugano 2014 criteria.
  • No serious concomitant diseases or active/uncontrolled infections.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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  • Cardiac function: left ventricular ejection fraction (LVEF) ≥ 40%.
  • Pulmonary function: pulse oximetry ≥ 90% on room air at rest.
  • Renal function: serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) or creatinine clearance ≥ 45 mL/min.
  • Absolute lymphocyte count (ALC) ≥ 0.2×10^9/L.
  • Alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate aminotransferase (AST) ≤ 2.5 × ULN, AND total bilirubin < 1.5 × ULN.
  • No ongoing coagulopathies requiring periodic replacement of clotting factors (eg, fresh frozen plasma, cryoprecipitate).
  • Women of childbearing potential must:
  • Have 2 negative pregnancy tests verified (one negative serum beta human chorionic gonadotropin [β-hCG] at screening and another within 48 hours prior to treatment withUB-VV400).
  • Commit to "true abstinence" from heterosexual intercourse or agree to use and complywith highly effective, uninterrupted contraception for 12 months after administration of UB-VV400 .
  • Abstain from breastfeeding for 12 months following administration of UB-VV400.
  • Men with partners of childbearing potential must commit to "true abstinence" from heterosexual intercourse or agree to use a highly effective form of contraception duringheterosexual contact with a pregnant individual or any individual of childbearing potential for 12 months after administration of UB-VV400, regardless of past vasectomy.
  • Subjects must agree not to donate blood, organs, sperm/semen, and/or egg cells for use for at least 1 year following treatment with UB-VV400 alone or in combination with rapamycin. Insufficient data are available to define a duration of time sufficient to make a recommendation on when it is safe to donate any tissue; therefore, subjects should not donate any tissue after administration of UB-VV400.

Who cannot join

  • Women who are pregnant or breastfeeding.
  • Subjects with current isolated central nervous system (CNS) tumor involvement.
  • Subjects with a prior malignancy whose clinical course or management has the potential to interfere with the safety and/or efficacy evaluation of the clinical trial.
  • Prior treatment with any of the following: allogeneic bone marrow transplantation, gene therapy, or adoptive cell transfer of any kind except for CAR T-cell therapy.
  • Treatment with prior CD22-directed therapy except for UB-VV400.
  • History of or active human immunodeficiency virus (HIV).
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  • Active hepatitis B (HepB) or hepatitis C (HepC).
  • For subjects receiving rapamycin: a. History of angioedema; b. Pneumonitis (Grade 3 or greater).
  • Ongoing Grade > 2 toxicities from the last line of anticancer therapy.
  • Use of the following:
  • Therapeutic systemic doses of corticosteroids (defined as > 20 mg prednisone equivalent) within 72 hours before dosing with UB-VV400.
  • Approved targeted therapies:
  • Small molecules: within 3 half-lives before dosing with UB-VV400 (see package insert). ii. Antibodies: within 14 days before dosing with UB-VV400. iii. CAR T therapy: within 28 days before dosing with UB-VV400. c. Autologous stem cell transplant within 28 days before dosing with UB-VV400. d. Cytotoxic chemotherapy (eg, alkylators, anthracyclines) within 14 days before dosing with UB-VV400.
  • Any experimental agent (ie, not approved for disease/indication or with accepted consensus guidelines recommendation) within 4 weeks before dosing with UB-VV400 unless progression has been documented and a minimum of 3 half-lives has elapsed.
  • Any immune-suppressing agent within 28 days before dosing with UB-VV400 (eg, tacrolimus, mycophenolate mofetil, immunosuppressive antibodies such as anti-tumor necrosis factor [TNF]/IL-6).
  • Radiation within 4 weeks before dosing with UB-VV400 (palliative radiation to a symptomatic lesion[s] is allowed if at least one additional, non-irradiated, measurable lesion remains present to assess response).
  • Prophylactic treatment with short-acting oral antiretroviral medications within 7 days before UB-VV400 administration. Long-acting antiretroviral prophylaxis is not allowed within 2 years of UB-VV400 treatment.
  • Allergies to rapamycin or supportive medications required for CAR T-cell toxicity management (eg, tocilizumab).
  • Systemic autoimmune diseases or immunodeficiency diseases (except for well-controlled type I diabetes with hemoglobin A1C [HbA1c] less than 8% or well-controlled thyroid disease, as assessed by the treating physician).
  • Ongoing CNS diseases (eg, seizure disorder, tremor, history of cerebral vascular accident [CVA]/recurrent transient ischemic attack [TIA]) that would preclude evaluation of immune effector cell-associated neurotoxicity syndrome (ICANS).
  • Presence of uncontrolled angina or other acute uncontrolled heart disease. Myocardial infarction within the previous 6 months. New York Heart Association (NYHA) Class III or IV. History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
  • Actively receiving treatment in other interventional clinical trials. Note: continued follow-up on previous trials is allowed for survivorship, but no further investigational agents or assessments will be allowed.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Changpu Cao contact

+86-13584069411

changpu.cao@iasobio.com

China2 sites, 2 recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing

    Lei Fan

    Recruiting

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin

    Liang Huang

    Dehui Zou

    Not yet recruiting

Other trials in China

About this study

Official title: An Exploratory, Open-label Study of UB-VV400 in Combination With Rapamycin in Relapsed or Refractory B-cell Malignancies

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.

Being tested
UB-VV400, Rapamycin
Keywords
UB-VV400, relapsed or refractory, Large B-cell Lymphoma
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UB-VV400Genetic

    UB-VV400 is a third-generation, self-inactivating (SIN), replication-incompetent, lentiviral vector (LVV) investigational drug product

  • RapamycinDrug

    In DF Stage 2, Rapamycin will be given in combination with UB-VV400. For subjects receiving rapamycin, rapamycin dosing will be once daily with a planned start date of Day 4 (approximately 72 hours after the administration of UB-VV400) and continuing for up to 60 days, as tolerated.

Study groups in NCT06743503
Study groupRoleWhat they receive
treatment groupExperimentalInterventions: UB-VV400 with or without Rapamycin. Dosage and Administration:single dose of UB-VV400 intravenous injection at Day 1. For subjects receiving rapamycin, dosing should be planned to be initiated on Study Day 4 and continued for up to 60 days, as tolerated .
Receives: Genetic: UB-VV400; Drug: Rapamycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events as assessed by CTCAE v5.0

    Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities

    Measured: up to 24 months

  2. Maximum tolerated dose (MTD) or maximum administered dose (MAD) of UB-VV400 alone and in combination with rapamycin.

    Measured: up to 24 months

Secondary outcomes (1)

  1. Objective response rate (ORR) per the Investigator using the Lugano 2014 criteria.

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2024
  2. Study start11 Apr 2025
  3. Primary completion21 May 2028 (estimated)
  4. Study completion31 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06743503
Sponsor's protocol ID
UB-VV400CI001
Status last verified
Sep 2025
First submitted
10 Dec 2024
Last updated
18 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UB-VV400 and Rapamycin in people with Large B-cell Lymphoma, run by Nanjing IASO Biotechnology Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Changpu Cao (+86-13584069411, changpu.cao@iasobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events as assessed by CTCAE v5.0 (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06743503.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.

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