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Not yet recruiting NCT07735533

A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies

Phase I / Phase II Interventional Lymphoma, B Cell Lymphoma Non-Hodgkin High Grade B Cell Lymphoma Richter Transformation Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UB-VV400, Rapamycin (sirolimus).
Who it may be relevant to
Registry conditions: Lymphoma, B Cell, Lymphoma Non-Hodgkin, High Grade B Cell Lymphoma, Richter Transformation Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1/2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies

Overview

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).

Interventions

  • Genetic UB-VV400
    UB-VV400 is a gene therapy that generates CD22-directed CAR T cells in the body.
  • Drug Rapamycin (sirolimus)
    Rapamycin is a drug approved by the FDA for indications unrelated to cancer.

Primary outcome measures

  • Phase 1: Percentage of participants with common adverse events (AEs) [Time frame: Up to 2 years after UB-VV400 administration]
  • Phase 2: Overall response rate (ORR) [Time frame: Up to 2 years after UB-VV4001 administration]
Secondary outcome measures (8)
  • Phase 1: Overall response rate (ORR) [Time frame: Up to 2 years after UB-VV400 administration]
  • Phase 1 and Phase 2: Complete response rate (CRR) [Time frame: Up to 2 years after UB-VV400 administration]
  • Phase 1 and Phase 2: Pharmacokinetics (PK) of UB-VV400 [Time frame: Up to 8 days after UB-VV400 administration]
  • Phase 2: Percentage of participants with common AEs [Time frame: Up to 2 years after UB-VV111 administration]
  • Phase 2: Duration of response (DOR) [Time frame: Up to 2 years after UB-VV400 administration]
  • Phase 2: Progression-free survival (PFS) [Time frame: Up to 2 years after UB-VV400 administration]
  • Phase 2: Overall survival (OS) [Time frame: Up to 2 years after UB-VV400 administration]
  • Phase 2: Quality of life (QOL) [Time frame: Up to 2 years after UB-VV400 administration]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07735533 · UB-VV400-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗