RightFit
RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests the safety of different doses of UB-VV111, with or without rapamycin, and how well it fights cancer. It is for adults with CD19-positive large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia (CLL) that has come back or has not responded to treatment. CD19 is a marker on cancer cells.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older and freely agree in writing to join.
  • You have LBCL or CLL that has come back or has not responded to treatment.
  • Your cancer can be measured using the study’s rules.
  • You have no serious other illnesses or active or uncontrolled infections.
  • You can do all usual activities, or can walk and do light work but not hard physical activity.
  • Your organs work well enough for the study.
  • If you had treatment targeting CD19, a tissue sample taken after that treatment must show that your cancer still has CD19.

Who can't join

  • You are pregnant or breastfeeding.
  • Your cancer is currently only in your brain or spinal cord.
  • You had a bone marrow transplant from a donor, gene therapy, or treatment with transferred immune cells. CAR T cells and tumor-infiltrating lymphocytes are allowed exceptions.
  • You have HIV or a history of HIV, or active hepatitis B or C.
  • You have a disease that weakens the body’s immune defenses. Well-controlled type 1 diabetes or thyroid disease are allowed exceptions.
  • You have an ongoing brain or spinal cord disease that prevents tests of your nervous system.
  • You have uncontrolled heart-related chest pain or another acute heart disease.
  • You are receiving treatment in another clinical trial that tests a treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (7)

CA

IL

MI

MO

NE

OH

WA