Testing UB-VV111 with and without Rapamycin for B-cell cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study evaluates the safety and effectiveness of UB-VV111, both alone and in combination with rapamycin, in patients with relapsed or refractory large B-cell lymphoma and chronic lymphocytic leukemia. The study employs a dose-escalation and dose-confirmation methodology to determine the optimal dosing and assess antitumor activity. Participants must have measurable disease and meet specific eligibility criteria, including adequate organ function and performance status.

Why it matters

Who can join: the full rules

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.

Exclusion Criteria:

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 (exceptions include tumor-infiltrating lymphocytes and CAR T cells)
4. History of or active human immunodeficiency virus (HIV)
5. Active hepatitis B or C
6. Systemic 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.

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• The David and Etta Jonas Center for Cellular Therapy
  Chicago, Illinois, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• Washington University School of Medicine/Siteman Cancer Center
  St Louis, Missouri, United States Recruiting
• University of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting
• University of Cincinnatti Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: Luke Walker, MD
• Email: luke.walker@umoja-biopharma.com
• Phone: 206-227-5056

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ibrutinib and Venetoclax in CLL/SLL: Long-Term Outcomes After Frontline CAPTIVATE

  This study follows people with CLL or SLL who previously received the ibrutinib plus venetoclax combination in CAPTIVATE to see how they do over time and what treatments they need if the disease returns.

  Recruiting European Research Initiative on CLL · Milan · NCT07774390

• UB-VV400 with rapamycin in relapsed/refractory B-cell lymphomas

  A phase 1/2 trial tests UB-VV400 plus rapamycin in adults with relapsed or refractory B-cell lymphomas to see if it is safe and shows anti-tumor activity.

  Recruiting at 2 sites Phase 1/2 Umoja Biopharma · Irvine, California and 1 other locations · NCT07735533

• Impact of Targeted Therapy on Cancer-Related Cognitive Impairment

  This study checks whether brain health and well‑being differ for people with leukemia who are starting or on TKI therapy compared with similar individuals without cancer or TKI exposure.

  Recruiting University of Rochester · Rochester, New York · NCT07638007

• BTK degrader plus BCL-2 inhibitor in untreated CLL/SLL

  This phase 2 study tests whether the BTK degrader BGB-16673 together with sonrotoclax can help people with newly diagnosed CLL/SLL.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT07508995

• Immune profiling during first-line pirtobrutinib treatment for CLL/SLL

  This will test pirtobrutinib as a first treatment for adults with CLL or SLL and see how it changes immune cells in the blood and lymph nodes.

  Recruiting Early Phase 1 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07428707

• NX-5948 treatment for adults with CLL or SLL after prior BTK and BCL-2 inhibitor therapy

  NX-5948, an oral BTK degrader, will be tried to see if it helps adults with relapsed or refractory CLL or SLL who have already been treated with both BTK and BCL-2 inhibitors.

  Recruiting at 43 sites Phase 2 Nurix Therapeutics, Inc. · Phoenix, Arizona and 42 other locations · NCT07221500

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.