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

Description

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).

Conditions

Lymphoma, B-Cell, Lymphoma, Non-Hodgkin (NHL), Lymphoma, Large B-Cell, Diffuse (DLBCL), Chronic Lymphocytic Leukemia (CLL)

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Study Overview

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Study Details

Study overview

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).

A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies

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

Condition
Lymphoma, B-Cell
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope, Duarte, California, United States, 91010

Saint Louis

Washington University School of Medicine/Siteman Cancer Center, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Umoja Biopharma,

Jacob Garcia, MD, STUDY_DIRECTOR, Umoja Biopharma

Study Record Dates

2029-04