Lymphoma, B-CellPhase 1NCT06528301
A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
A Phase 1 study testing UB-VV111 and rapamycin in people with Lymphoma, B-Cell and Lymphoma, Non-Hodgkin (NHL), run by Umoja Biopharma at 9 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin (NHL), Lymphoma, Large B-Cell, Diffuse (DLBCL)
- What is being tested?
- UB-VV111 and rapamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 10 Mar 2025to Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Ongoing CNS disease that would preclude neurologic assessment
- Uncontrolled angina or other acute heart disease
- Currently receiving treatment in another interventional clinical trial.
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Christine Dehner contact
9 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
The David and Etta Jonas Center for Cellular Therapy
Chicago, Illinois, 60637
Michael Bishop, MD, 773-702-6149, cancerclinicaltrials@bsd.uchicago.edu
Michael Bishop, MD
- Recruiting
University of Cincinnatti Medical Center
Cincinnati, Ohio, 45219
Hani Alrefai, MBBCh, MS, PhD, 513-584-8438, alrefahd@ucmail.uc.edu
Zulfa Omer, MD
- Recruiting
City of Hope
Duarte, California, 91010
Tanya Siddiqi, MD, 626-218-2405, tsiddiqi@coh.org
Tanya Siddiqi, MD
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Julie Burns, hopeteam@startresearch.com
Andrew Sochacki
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198-6814
Brooke Tridle, MHA, 402-559-5101, brtridle@unmc.edu
Matthew Lunning, D.O. F.A.C.P.
- Recruiting
Fred Hutch Cancer Center
Seattle, Washington, 98109
Shelby Colden, 206-667-5134, scolden2@fredhutch.org
Ajay Gopal, MD/FACP
- Recruiting
Washington University School of Medicine/Siteman Cancer Center
St Louis, Missouri, 63110
Yalda Karamlou, 314-273-3776, yalda@wustl.edu
Zachary Crees, MD
Australia2 sites, 2 recruiting
- Recruiting
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Joseph Nguyen-Vo, +61 3 9231 3263, Joseph.Nguyen@svha.org.au
Matthew Ku, MD
- Recruiting
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
Cameron Turtle, MBBS, PhD, +61299264377
Cameron Turtle, MBBS, PhD
About this study
Official title: A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies
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).
- Conditions
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin (NHL), Lymphoma, Large B-Cell, Diffuse (DLBCL), Chronic Lymphocytic Leukemia (CLL)
- Being tested
- UB-VV111, rapamycin
- Keywords
- CAR T, CD19, chimeric antigen receptor
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-VV111Genetic
UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body.
rapamycinDrug
Also called Rapamune, sirolimus
Rapamycin is an FDA-approved drug.
| Study group | Role | What they receive |
|---|---|---|
| UB-VV111 | Experimental | A single dose of UB-VV111 will be administered. Receives: Genetic: UB-VV111 |
| UB-VV111 + rapamycin | Experimental | A single dose of UB-VV111 will be administered followed by treatment with rapamycin. Receives: Genetic: UB-VV111; Drug: rapamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with common adverse events (AEs)
Percentage of participants with commonly reported AEs overall and by severity
Measured: Up to 2 years after UB-VV111 administration
Secondary outcomes (1)
Overall response rate (ORR)
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)
Measured: Up to 2 years after UB-VV111 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start10 Mar 2025
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umoja Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luke Walker, MD, Study director, Umoja Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528301
- Sponsor's protocol ID
- UB-VV111-01
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies
- ClinicalTrials.gov ID
- NCT06528301
- Acronym / sponsor ID
- UB-VV111-01
- Conditions
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin (NHL), Lymphoma, Large B-Cell, Diffuse (DLBCL), Chronic Lymphocytic Leukemia (CLL)
- Keywords
- CAR T, CD19, chimeric antigen receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Umoja BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UB-VV111 | Experimental | Genetic: UB-VV111A single dose of UB-VV111 will be administered. |
| UB-VV111 + rapamycin | Experimental | Genetic: UB-VV111, Drug: rapamycinA single dose of UB-VV111 will be administered followed by treatment with rapamycin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UB-VV111UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body. | Genetic | UB-VV111, UB-VV111 + rapamycin |
| rapamycinAlso: Rapamune, sirolimusRapamycin is an FDA-approved drug. | Drug | UB-VV111 + rapamycin |
Primary outcome
Percentage of participants with common adverse events (AEs)
Time frame: Up to 2 years after UB-VV111 administration
Percentage of participants with commonly reported AEs overall and by severity
1 secondary outcome
Overall response rate (ORR)
Time frame: Up to 2 years after UB-VV111 administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Lymphoma, B-Cell
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Dehner contact
Luke Walker, MD study director
Umoja Biopharma
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UB-VV111 and rapamycin in people with Lymphoma, B-Cell and Lymphoma, Non-Hodgkin (NHL), run by Umoja Biopharma at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luke Walker, MD (206-227-5056, luke.walker@umoja-biopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with common adverse events (AEs) (time frame: Up to 2 years after UB-VV111 administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.