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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug, Genetic
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years or older

• Provides voluntary written informed consent

• Relapsed or refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia (CLL)

• Measurable disease according to Lugano 2014 criteria (LBCL) or iwCLL 2018 (CLL).

• No serious concomitant diseases or active/uncontrolled infections

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate organ function

• Patients who have previously received CD19-directed therapy must have biopsy confirming CD19 expression following completion of prior CD19-directed therapy.

Locations
United States
California
City of Hope
NOT_YET_RECRUITING
Duarte
Illinois
The David and Etta Jonas Center for Cellular Therapy
RECRUITING
Chicago
Missouri
Washington University School of Medicine/Siteman Cancer Center
RECRUITING
St Louis
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
Ohio
University of Cincinnatti Medical Center
RECRUITING
Cincinnatti
Washington
Fred Hutch Cancer Center
RECRUITING
Seattle
Other Locations
Australia
St. Vincent's Hospital Melbourne
RECRUITING
Fitzroy
Royal North Shore Hospital
RECRUITING
Saint Leonards
Contact Information
Primary
Jacob Garcia, MD
jacob.garcia@umoja-biopharma.com
425-873-8331
Backup
Christine Dehner
christine.dehner@umoja-biopharma.com
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2029-03
Participants
Target number of participants: 106
Treatments
Experimental: UB-VV111
A single dose of UB-VV111 will be administered.
Experimental: UB-VV111 + rapamycin
A single dose of UB-VV111 will be administered followed by treatment with rapamycin.
Sponsors
Leads: Umoja Biopharma

This content was sourced from clinicaltrials.gov

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