NCT07735533

Brief 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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for phase_1

Timeline
61mo left

Started Aug 2026

Longer than P75 for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2031

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

5 years

First QC Date

July 24, 2026

Last Update Submit

July 24, 2026

Conditions

Lymphoma, B CellLymphoma Non-HodgkinHigh Grade B Cell LymphomaRichter Transformation LymphomaGrade 3b Follicular LymphomaPrimary Mediastinal B Cell LymphomaDiffuse Large B Cell Lymphoma (DLBCL)

Keywords

CAR Tchimeric antigen receptorCD22

Outcome Measures

Primary Outcomes (2)

  • Phase 1: Percentage of participants with common adverse events (AEs)

    Percentage of participants with commonly reported AEs overall and by severity

    Up to 2 years after UB-VV400 administration

  • Phase 2: Overall response rate (ORR)

    Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)

    Up to 2 years after UB-VV4001 administration

Secondary Outcomes (8)

  • Phase 1: Overall response rate (ORR)

    Up to 2 years after UB-VV400 administration

  • Phase 1 and Phase 2: Complete response rate (CRR)

    Up to 2 years after UB-VV400 administration

  • Phase 1 and Phase 2: Pharmacokinetics (PK) of UB-VV400

    Up to 8 days after UB-VV400 administration

  • Phase 2: Percentage of participants with common AEs

    Up to 2 years after UB-VV111 administration

  • Phase 2: Duration of response (DOR)

    Up to 2 years after UB-VV400 administration

  • +3 more secondary outcomes

Study Arms (1)

UB-VV400 + rapamycin

EXPERIMENTAL

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

Genetic: UB-VV400Drug: Rapamycin (sirolimus)

Interventions

UB-VV400GENETIC

UB-VV400 is a gene therapy that generates CD22-directed CAR T cells in the body.

UB-VV400 + rapamycin
Rapamycin (sirolimus)DRUG

Rapamycin is a drug approved by the FDA for indications unrelated to cancer.

Also known as: Rapamune
UB-VV400 + rapamycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Women who are pregnant or breastfeeding
  • Current isolated central nervous system (CNS) involvement
  • 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)
  • 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
  • Currently receiving treatment in another interventional clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, B-CellLymphoma, Non-HodgkinLymphoma, Large B-Cell, Diffuse

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Jacob Garcia, MD

    Umoja Biopharma

    STUDY DIRECTOR

Central Study Contacts

Jacob Garcia, MD

CONTACT

425-873-8331jacob.garcia@umoja-biopharma.com

Christine Dehner

CONTACT

christine.dehner@umoja-biopharma.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 30, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2031

Study Completion (Estimated)

August 1, 2031

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share