NCT06528301 A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
| NCT ID | NCT06528301 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Umoja Biopharma |
| Condition | Lymphoma, B-Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 106 participants in total. It began in 2025-03-10 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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 (except CAR T-cell therapy in CAR T-exposed subjects) 4. History of or active human immunodeficiency virus (HIV) 5. Active hepatitis B or C 6. Systemic autoimmune or 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.
Contact & Investigator
Jacob Garcia, MD
STUDY DIRECTOR
Umoja Biopharma
Frequently Asked Questions
Who can join the NCT06528301 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoma, B-Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06528301 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06528301 currently recruiting?
Yes, NCT06528301 is actively recruiting participants. Contact the research team at jacob.garcia@umoja-biopharma.com for enrollment information.
Where is the NCT06528301 trial being conducted?
This trial is being conducted at Duarte, United States, Chicago, United States, St Louis, United States, Omaha, United States and 4 additional locations.
Who is sponsoring the NCT06528301 clinical trial?
NCT06528301 is sponsored by Umoja Biopharma. The principal investigator is Jacob Garcia, MD at Umoja Biopharma. The trial plans to enroll 106 participants.