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NCT Number: NCT07735533

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

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).

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Key information

Conditions

Lymphoma, B Cell Diffuse Large B Cell Lymphoma (DLBCL) Grade 3b Follicular Lymphoma Hemic and Lymphatic Diseases High Grade B Cell Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Primary Mediastinal B Cell Lymphoma Richter Transformation Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UB-VV400

Genetic

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

Rapamycin (sirolimus)

Drug

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

Other names: Rapamune

Primary outcomes

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

    Time frame: Up to 2 years after UB-VV400 administration

    Percentage of participants with commonly reported AEs overall and by severity

  2. Phase 2: Overall response rate (ORR)

    Time frame: Up to 2 years after UB-VV4001 administration

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

Secondary outcomes

  1. Phase 1: Overall response rate (ORR)

    Time frame: Up to 2 years after UB-VV400 administration

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

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

    Time frame: Up to 2 years after UB-VV400 administration

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

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

    Time frame: Up to 8 days after UB-VV400 administration

    Maximum concentration (Cmax), time to maximum concentration (Tmax), and AUC (area under the concentration vs time curve) for UB-VV400

  4. Phase 2: Percentage of participants with common AEs

    Time frame: Up to 2 years after UB-VV111 administration

    Percentage of participants with commonly reported AEs overall and by severity

  5. Phase 2: Duration of response (DOR)

    Time frame: Up to 2 years after UB-VV400 administration

    Duration from first evidence of response (CR or PR) to date of first evidence of disease progression or death, whichever is earlier

  6. Phase 2: Progression-free survival (PFS)

    Time frame: Up to 2 years after UB-VV400 administration

    Duration from first administration of UB-VV400 to the first evidence of disease progression or death from any cause, whichever is earlier.

  7. Phase 2: Overall survival (OS)

    Time frame: Up to 2 years after UB-VV400 administration

    Duration from first administration of UB-VV400 to death from any cause

  8. Phase 2: Quality of life (QOL)

    Time frame: Up to 2 years after UB-VV400 administration

    Performance on 2 QoL scales: EuroQol instrument EQ-5D-5L and Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Dehner

CONTACT

[email protected]

Jacob Garcia, MD

CONTACT

[email protected]

425-873-8331

Sponsors and collaborators

Lead sponsor

Umoja Biopharma

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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