RECRUITING

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

Conditions

Lymphoma, B-Cell Lymphoma, Non-Hodgkin (NHL)Lymphoma, Large B-Cell, Diffuse (DLBCL)Chronic Lymphocytic Leukemia (CLL)CAR T CD19 chimeric antigen receptor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2024-12

Study Completion:2029-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06528301

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Jacob Garcia, MD

CONTACT

425-873-8331

jacob.garcia@umoja-biopharma.com

Christine Dehner

CONTACT

christine.dehner@umoja-biopharma.com

Principal Investigator

Jacob Garcia, MD

STUDY_DIRECTOR

Umoja Biopharma

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

Washington University School of Medicine/Siteman Cancer Center

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Umoja Biopharma

Jacob Garcia, MD, STUDY_DIRECTOR, Umoja Biopharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12

Study Completion Date2029-04

Study Record Updates

Study Start Date2024-12

Study Completion Date2029-04

Terms related to this study

Keywords Provided by Researchers

CAR T
CD19
chimeric antigen receptor

Additional Relevant MeSH Terms

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