Lymphoma, B CellPhase 1/2NCT07735533
A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies
A Phase 1/2 study testing UB-VV400 and Rapamycin (sirolimus) in people with Lymphoma, B Cell and Lymphoma Non-Hodgkin, run by Umoja Biopharma at 1 site in United States.
Trial summary
This study is a Phase 1/2 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV400. The study will enroll patients with relapsed/refractory B-cell malignancies, including large B-cell lymphoma (LBCL). 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, High Grade B Cell Lymphoma
- What is being tested?
- UB-VV400 and Rapamycin (sirolimus)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Aug 2031
- Phase
- Phase 1/2
- 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)
- Measurable disease according to Lugano 2014 criteria
- Confirmed CD22 expression
- No serious concomitant diseases or active/uncontrolled infections
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
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 (except tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor [TCR] fusion constructs, TCR T cells, and CAR T cells)
- History of or active human immunodeficiency virus (HIV)
- Active or chronic hepatitis B, or active hepatitis 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christine Dehner contact
United States1 site, 1 recruiting
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Clemence Walker, SCRI.DDUreferrals@scri.com
Krish Patel, MD
About this study
Official title: A Phase 1/2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies
This study is a Phase 1/2 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV400. The study will enroll patients with relapsed/refractory B-cell malignancies, including large B-cell lymphoma (LBCL).
- Conditions
- Lymphoma, B Cell, Lymphoma Non-Hodgkin, High Grade B Cell Lymphoma, Richter Transformation Lymphoma, Grade 3b Follicular Lymphoma, Primary Mediastinal B Cell Lymphoma
- Being tested
- UB-VV400, Rapamycin (sirolimus)
- Keywords
- CAR T, chimeric antigen receptor, CD22
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-VV400Genetic
UB-VV400 is a gene therapy that generates CD22-directed CAR T cells in the body.
Rapamycin (sirolimus)Drug
Also called Rapamune
Rapamycin is a drug approved by the FDA for indications unrelated to cancer.
| Study group | Role | What they receive |
|---|---|---|
| UB-VV400 + rapamycin | Experimental | A single dose of UB-VV400 will be administered followed by treatment with rapamycin. Receives: Genetic: UB-VV400; Drug: Rapamycin (sirolimus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: 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-VV400 administration
Phase 2: 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-VV4001 administration
Secondary outcomes (8)
Phase 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-VV400 administration
Phase 1 and Phase 2: Complete response rate (CRR)
Percentage of participants with a best overall response (BOR) of complete response (CR)
Measured: Up to 2 years after UB-VV400 administration
Phase 1 and Phase 2: Pharmacokinetics (PK) of UB-VV400
Maximum concentration (Cmax), time to maximum concentration (Tmax), and AUC (area under the concentration vs time curve) for UB-VV400
Measured: Up to 8 days after UB-VV400 administration
Phase 2: Percentage of participants with common AEs
Percentage of participants with commonly reported AEs overall and by severity
Measured: Up to 2 years after UB-VV111 administration
Phase 2: Duration of response (DOR)
Duration from first evidence of response (CR or PR) to date of first evidence of disease progression or death, whichever is earlier
Measured: Up to 2 years after UB-VV400 administration
Phase 2: Progression-free survival (PFS)
Duration from first administration of UB-VV400 to the first evidence of disease progression or death from any cause, whichever is earlier.
Measured: Up to 2 years after UB-VV400 administration
Phase 2: Overall survival (OS)
Duration from first administration of UB-VV400 to death from any cause
Measured: Up to 2 years after UB-VV400 administration
Phase 2: Quality of life (QOL)
Performance on 2 QoL scales: EuroQol instrument EQ-5D-5L and Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Measured: Up to 2 years after UB-VV400 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 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 274 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
- NCT07735533
- Sponsor's protocol ID
- UB-VV400-03
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2026
- Last updated
- 9 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies
- ClinicalTrials.gov ID
- NCT07735533
- Acronym / sponsor ID
- UB-VV400-03
- Conditions
- Lymphoma, B Cell, Lymphoma Non-Hodgkin, High Grade B Cell Lymphoma, Richter Transformation Lymphoma, Grade 3b Follicular Lymphoma, Primary Mediastinal B Cell Lymphoma
- Keywords
- CAR T, chimeric antigen receptor, CD22
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Umoja BiopharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 30 Jul 2026 (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 1/2 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV400. The study will enroll patients with relapsed/refractory B-cell malignancies, including large B-cell lymphoma (LBCL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UB-VV400 + rapamycin | Experimental | Genetic: UB-VV400, Drug: Rapamycin (sirolimus)A single dose of UB-VV400 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)
- Measurable disease according to Lugano 2014 criteria
- Confirmed CD22 expression
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 (except tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor [TCR] fusion constructs, TCR T cells, and CAR T cells)
- History of or active human immunodeficiency virus (HIV)
- Active or chronic hepatitis B, or active hepatitis 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-VV400UB-VV400 is a gene therapy that generates CD22-directed CAR T cells in the body. | Genetic | UB-VV400 + rapamycin |
| Rapamycin (sirolimus)Also: RapamuneRapamycin is a drug approved by the FDA for indications unrelated to cancer. | Drug | UB-VV400 + rapamycin |
Primary outcome
Phase 1: Percentage of participants with common adverse events (AEs)
Time frame: Up to 2 years after UB-VV400 administration
Percentage of participants with commonly reported AEs overall and by severity
Phase 2: Overall response rate (ORR)
Time frame: Up to 2 years after UB-VV4001 administration
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)
8 secondary outcomes
Phase 1: Overall response rate (ORR)
Time frame: Up to 2 years after UB-VV400 administration
Phase 1 and Phase 2: Complete response rate (CRR)
Time frame: Up to 2 years after UB-VV400 administration
Phase 1 and Phase 2: Pharmacokinetics (PK) of UB-VV400
Time frame: Up to 8 days after UB-VV400 administration
Phase 2: Percentage of participants with common AEs
Time frame: Up to 2 years after UB-VV111 administration
Phase 2: Duration of response (DOR)
Time frame: Up to 2 years after UB-VV400 administration
Phase 2: Progression-free survival (PFS)
Time frame: Up to 2 years after UB-VV400 administration
Phase 2: Overall survival (OS)
Time frame: Up to 2 years after UB-VV400 administration
Phase 2: Quality of life (QOL)
Time frame: Up to 2 years after UB-VV400 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 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Lymphoma, B Cell
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
RecruitingPhase 2
CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, B-All
RecruitingPhase 1
Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma
RecruitingPhase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UB-VV400 and Rapamycin (sirolimus) in people with Lymphoma, B Cell and Lymphoma Non-Hodgkin, run by Umoja Biopharma at 1 site in United States.
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 9 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 1 site in United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Phase 1: Percentage of participants with common adverse events (AEs) (time frame: Up to 2 years after UB-VV400 administration). The study lists 2 primary outcomes in all. 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 9 Oct 2026.