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Taking people in United StatesPhase 1/2

UB-VV400 with rapamycin for B-cell lymphoma that has returned or not responded

Tests UB-VV400 with rapamycin in adults with relapsed or treatment-resistant B-cell lymphoma.

Key facts

Who runs it
Umoja Biopharma
Where
Irvine and Nashville, United StatesSee the 2 sites
Trial code
Registry title
A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies
Status
Recruiting
Phase
Phase 1/2
People taking part
274 people, planned
Started
Nov 2026
Expected to end
Aug 2031
Type of study
Interventional
Treatments tested
  • UB-VV400
  • Rapamycin (sirolimus)
Record updated
10 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose large B-cell lymphoma has come back or has not responded to treatment, and whose cancer cells show CD22.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Large B-cell lymphoma (LBCL) that has come back or did not respond to treatment, with disease that can be measured by Lugano 2014 criteria. ECOG performance status of 0 or 1.
Earlier treatment
Not stated beyond relapsed or refractory disease. Prior allogeneic bone marrow transplant, gene therapy or adoptive cell transfer cannot be part of the history, with some exceptions (tumor-infiltrating lymphocytes, CAR-NK cells, TCR fusion constructs, TCR T cells, CAR T cells).
Biomarker or test result
CD22 expression must be confirmed.

Main reasons for not taking part

  • Pregnant or breastfeeding women
  • Current isolated central nervous system (CNS) involvement
  • History of or active HIV, or active or chronic hepatitis B, or active hepatitis C
  • Systemic immunodeficiency diseases, except well-controlled Type I diabetes or thyroid disease
  • Currently in another interventional clinical trial

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 18 years or older
  • Provides voluntary written informed consent
  • Relapsed or refractory large B-cell lymphoma (LBCL)
  • Measurable disease according to Lugano 2014 criteria
  • Confirmed CD22 expression
  • No serious concomitant diseases or active/uncontrolled infections
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function

Who cannot take part

  • Currently receiving treatment in another interventional clinical trial
  • History of or active human immunodeficiency virus (HIV)
  • Active or chronic hepatitis B, or active hepatitis C
  • Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
  • Ongoing CNS disease that would preclude neurologic assessment
  • Uncontrolled angina or other acute heart disease
  • 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)
  • Women who are pregnant or breastfeeding
  • Current isolated central nervous system (CNS) involvement

Where in United States

  • City of HopeIrvine, United StatesContact: Azra Borogovac, MD, MSTaking people
  • Sarah Cannon Research InstituteNashville, United StatesContact: Clemence WalkerTaking people

About the trial

What the trial wants to find out

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).

The group in the trial

  • UB-VV400 + rapamycinTreatment being tested

    A single dose of UB-VV400 will be administered followed by treatment with rapamycin.

    Treatment: UB-VV400 and Rapamycin (sirolimus)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 1/2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies
Plain-language title
UB-VV400 with rapamycin for B-cell lymphoma that has returned or not respondedGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
10 November 2026