Recruiting
Phase 1
Phase 2

UB-VV400

Sponsor:

Umoja Biopharma

Code:

NCT07735533

Conditions

Lymphoma, B Cell

Lymphoma Non-Hodgkin

High Grade B Cell Lymphoma

Richter Transformation Lymphoma

Grade 3b Follicular Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

UB-VV400

Rapamycin (sirolimus)

Study Details

Brief 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).

Conditions

Lymphoma, B Cell

Lymphoma Non-Hodgkin

High Grade B Cell Lymphoma

Richter Transformation Lymphoma

Grade 3b Follicular Lymphoma

Study ID

NCT07735533

Start date

Sep, 2026

Status verified date

Oct, 2026

Completion date

Aug, 2031

Anticipated

Primary completion date

Aug, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18 years or older
2. Provides voluntary written informed consent
3. Relapsed or refractory large B-cell lymphoma (LBCL)
4. Measurable disease according to Lugano 2014 criteria
5. Confirmed CD22 expression
6. No serious concomitant diseases or active/uncontrolled infections
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
8. Adequate organ function

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 (except tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor \[TCR\] fusion constructs, TCR T cells, and CAR T cells)
4. History of or active human immunodeficiency virus (HIV)
5. Active or chronic hepatitis B, or active hepatitis 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 Design

Enrollment

274 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: UB-VV400 + rapamycin

A single dose of UB-VV400 will be administered followed by treatment with rapamycin.

Interventions

UB-VV400

UB-VV400 is a gene therapy that generates CD22-directed CAR T cells in the body.

Rapamycin (sirolimus)

Rapamycin is a drug approved by the FDA for indications unrelated to cancer.

Primary outcome measure

  • Phase 1: Percentage of participants with common adverse events (AEs) [ Time Frame: Up to 2 years after UB-VV400 administration ]
  • Phase 2: Overall response rate (ORR) [ Time Frame: Up to 2 years after UB-VV4001 administration ]

Central Contacts and Locations

Locations

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Principal Investigator:

Krish Patel, MD

More Information

Sponsor

Umoja Biopharma

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • CAR T
  • chimeric antigen receptor
  • CD22

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Umoja Biopharma on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.