Actively Recruiting
CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL)
Led by Vittoria Biotherapeutics · Updated on 2025-11-10
30
Participants Needed
2
Research Sites
255 weeks
Total Duration
On this page
Sponsors
V
Vittoria Biotherapeutics
Lead Sponsor
U
University of Pennsylvania
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label phase I study to determine the safety and recommended phase 2 dose (RP2D) of Senza5 CART5 cells in patients with relapsed or refractory CD5 positive nodal T cell NHL. RP2D will be based on the safety, tolerability, pharmacokinetics, and preliminary efficacy of Senza5 CART5 cells. This trial will evaluate up to 5 dose levels using the Bayesian Optimal Interval (BOIN) design enrolling 3 patients in each cohort to assess safety and achieve therapeutic levels so that the RP2D of Senza5 CART5 cells given as a single IV infusion can be determined.
CONDITIONS
Official Title
CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed relapsed or refractory CD5-positive nodal peripheral T-cell lymphoma or similar non-leukemic CD5-positive aggressive mature T cell lymphomas
- At least 50% expression of CD5 on malignant cells by flow cytometry or immunohistochemistry on the most recent biopsy
- Received at least one prior systemic therapy for lymphoma; for anaplastic large cell lymphoma, prior brentuximab unless contraindicated
- Evaluable disease with at least one lesion measurable by CT or PET scan at least 1.5 cm in longest dimension, or bone/bone marrow or skin involvement
- No circulating CD5-positive malignant cells detected by peripheral blood flow cytometry
You will not qualify if you...
- Pregnant or lactating women
- HIV infection
- Concurrent use of systemic steroids or immunosuppressants
- Any uncontrolled active medical disorder that would prevent participation
- History of immunodeficiency
- Previous chimeric antigen receptor therapy or autologous/syngeneic hematopoietic cell transplant less than 100 days before infusion or prior allogeneic transplant
- Active or systemic inflammatory or autoimmune diseases
- Signs or symptoms of active central nervous system involvement
- Known history of optic neuritis or other immune-related CNS diseases unrelated to lymphoma or its treatment
- Clinically apparent or unstable arrhythmias
- Participation in another investigational study or use of an investigational device within 2 weeks before treatment
- Prior monoclonal antibody therapy within 4 weeks before study start
- Prior use of alemtuzumab
- Prior chemotherapy, targeted small molecule therapy, or radiation within 2 weeks before study start
- Uncontrolled active infection requiring systemic therapy
- Presence of circulating CD5-positive malignant cells by blood flow cytometry
- Active or systemic inflammatory or autoimmune diseases
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
2
University of Pennsylvania - Abramson Caner Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
V
Vittoria Biotherapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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