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

Study Identifier:
UB-VV111-01
CT.gov Identifier:
NCT06528301
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study 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).

To study UB-VV111 administered IN or IV +/- rapamycin in CAR-naïve and CAR-exposed subjects with R/R LBCL and CLL/SLL.

To determine the safety profile, maximum tolerated/administered dose, and recommended Phase 2 dose of UB-VV111 +/- rapamycin.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Leukemia
Lymphoma, Non-Hodgkin's
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: UB-VV111
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Drug: Experimental: UB-VV111 + rapamycin
Drug: Drug: rapamycin
Drug: ASH 2024:
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
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.
  • Major eligibility criteria include adults with R/R LBCL/CLL/SLL following at least 2 lines of prior therapy who have standard organ function, measurable disease according to Lugano 2014 (LBCL) or iwCLL 2018 (CLL/SLL), ECOG 0 or 1, and no prior allogeneic transplant. Confirmation of CD19 expression will be required for all subjects with prior CD19-directed therapy.
  • 8 years or older
  • Relapsed or refractory LBCL or
  • CLL/SLL after 2 prior lines of therapy
  • Measurable disease according to
  • Lugano 2014 criteria (LBCL) or
  • International Workshop on Chronic
  • Lymphocytic Leukemia (iwCLL) 2018
  • (CLL)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • Patients who have previously received CDI 9-directed therapy must have biopsy confirming CDI 9 expression following completion of prior CDI 9- directed therapy.
Exclusion criteria
  • Women who are pregnant or breastfeeding.
  • Current isolated central nervous system (CNS) involvement
  • Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (exceptions include tumor-infiltrating lymphocytes and CAR T cells)
  • History of or active human immunodeficiency virus (HIV)
  • Active hepatitis B or C
  • Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
  • Ongoing CNS disease that would preclude neurologic assessment
  • Uncontrolled angina or other acute heart disease.
  • Currently receiving treatment in another interventional clinical trial.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Andrew Sochacki
Status
Will Be Recruiting
Condition(s) Treated at Site
Leukemia
Lymphoma, Non-Hodgkin's