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

Part of paid clinical trials in Duarte, California.

Sponsor
Umoja Biopharma
Study ID
NCT06528301
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UB-VV111 — GENETIC
    UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body.
  • rapamycin — DRUG
    Rapamycin is an FDA-approved drug.

Study Details

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).

Key Dates

Start date
Mar 10, 2025
Status verified
May 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
106 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Percentage of participants with common adverse events (AEs) [ Time Frame: Up to 2 years after UB-VV111 administration ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Tanya Siddiqi, MD
[email protected]
626-218-2405
Tanya Siddiqi, MD (PRINCIPAL_INVESTIGATOR)
The David and Etta Jonas Center for Cellular TherapyChicagoIllinois60637
Michael Bishop, MD
[email protected]
773-702-6149
Michael Bishop, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of Medicine/Siteman Cancer CenterSt LouisMissouri63110
Yalda Karamlou
[email protected]
314-273-3776
Zachary Crees, MD (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198-6814
Brooke Tridle, MHA
[email protected]
402-559-5101
Matthew Lunning, D.O. F.A.C.P. (PRINCIPAL_INVESTIGATOR)
University of Cincinnatti Medical CenterCincinnatiOhio45219
Hani Alrefai, MBBCh, MS, PhD
[email protected]
513-584-8438
Zulfa Omer, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutch Cancer CenterSeattleWashington98109
Shelby Colden
[email protected]
206-667-5134
Ajay Gopal, MD/FACP (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAThe David and Etta Jonas Center for Cellular Therapy· Chicago, ILWashington University School of Medicine/Siteman Cancer Center· St Louis, MOUniversity of Nebraska Medical Center· Omaha, NEUniversity of Cincinnatti Medical Center· Cincinnati, OHFred Hutch Cancer Center· Seattle, WA

Related Studies