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NCT06528301 | RECRUITING | Lymphoma, B-Cell

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
Sponsor:

Union biopharma

Brief Summary:

This study is a Phase 1 dose-escalation and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV111. The study will enroll patients with relapsed/refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).

Condition or disease

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin (NHL)

Lymphoma, Large B-Cell, Diffuse (DLBCL)

Chronic Lymphocytic Leukemia (CLL)

Intervention/treatment

UB-VV111

rapamycin

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 106 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies
Actual Study Start Date : 2025-03
Estimated Primary Completion Date : 2029-04
Estimated Study Completion Date : 2029-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. 18 years or older
  • 2. Provides voluntary written informed consent
  • 3. Relapsed or refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia (CLL)
  • 4. Measurable disease according to Lugano 2014 criteria (LBCL) or iwCLL 2018 (CLL).
  • 5. No serious concomitant diseases or active/uncontrolled infections
  • 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • 7. Adequate organ function
  • 8. Patients who have previously received CD19-directed therapy must have biopsy confirming CD19 expression following completion of prior CD19-directed therapy.
Exclusion Criteria
  • 1. Women who are pregnant or breastfeeding
  • 2. Current isolated central nervous system (CNS) involvement
  • 3. Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except CAR T-cell therapy in CAR T-exposed subjects)
  • 4. History of or active human immunodeficiency virus (HIV)
  • 5. Active hepatitis B or C
  • 6. Systemic autoimmune or immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
  • 7. Ongoing CNS disease that would preclude neurologic assessment
  • 8. Uncontrolled angina or other acute heart disease
  • 9. Currently receiving treatment in another interventional clinical trial.
A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

Location Details

NCT06528301

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, California

City of Hope

Duarte, California, United States, 91010

RECRUITING

United States, Missouri

Washington University School of Medicine/Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, Nebraska

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198-6814

RECRUITING

Australia, Victoria

St. Vincent's Hospital Melbourne

Fitzra, Victoria, Australia, 3065