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Trial Title:
A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
NCT ID:
NCT06528301
Condition:
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin (NHL)
Lymphoma, Large B-Cell, Diffuse (DLBCL)
Chronic Lymphocytic Leukemia (CLL)
Conditions: Official terms:
Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Sirolimus
Conditions: Keywords:
CAR T
CD19
chimeric antigen receptor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
UB-VV111
Description:
UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body.
Arm group label:
UB-VV111
Arm group label:
UB-VV111 + rapamycin
Intervention type:
Drug
Intervention name:
rapamycin
Description:
Rapamycin is an FDA-approved drug.
Arm group label:
UB-VV111 + rapamycin
Other name:
Rapamune, sirolimus
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).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 2024
Completion date:
March 2029
Lead sponsor:
Agency:
Umoja Biopharma
Agency class:
Industry
Source:
Umoja Biopharma
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06528301
