Recruiting
Phase 1

Senza5 CART5

Sponsor:

Vittoria Biotherapeutics

Code:

NCT06420089

Conditions

T Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Senza5 CART5

Study Details

Brief summary:

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

T Cell Non-Hodgkin Lymphoma

Study ID

NCT06420089

Start date

Oct 4, 2024

Status verified date

Jul, 2025

Completion date

Aug 30, 2029

Anticipated

Primary completion date

Aug 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Histologically or cytologically confirmed relapsed or refractory (r/r) CD5-positive nodal peripheral T-cell lymphoma (such as peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), nodal T-cell lymphomas with T-follicular helper (TFH) phenotype, including follicular T cell lymphoma, angioimmunoblastic lymphoma, or anaplastic large cell lymphoma) or other non-leukemic CD5+ aggressive mature T cell lymphomas (such as enteropathy-associated T cell lymphoma, monomorphic epitheliotropic intestinal T cell lymphoma, transformed mycosis fungoides, primary cutaneous aggressive epidermotropic CD8+ cytotoxic T-cell lymphoma, primary cutaneous insert gamma delta symbols lymphoma, or subcutaneous panniculitis like T cell lymphoma).
2. ≥50% expression of CD5 on flow cytometry or IHC on malignant cells on the most recent biopsy
3. Must have received at least one line of prior systemic therapy for their lymphoma; participants with anaplastic large cell lymphoma (ALCL) must have received prior brentuximab unless there was a contraindication to brentuximab.
4. Evaluable disease defined by at least one lesion that can be measured in least 1 dimension and measures at least 1.5 cm in its longest dimension by CT or PET scan, or bone/bone marrow involvement, or skin involvement.
5. No circulating CD5+ malignant cells identified by peripheral blood flow cytometry must be present.

Exclusion Criteria:

1. Pregnant or lactating (nursing) women.
2. HIV infection.
3. Concurrent use of systemic steroids or immunosuppressant medications.
4. Any uncontrolled active medical disorder that would preclude participation as outlined.
5. History of immunodeficiency.
6. History of prior chimeric antigen receptor therapy (CAR T), autologous or syngeneic HCT <100 days from transplant at the time of cell infusion or previous allo-HCT.
7. Active and/or systemic inflammatory or autoimmune diseases.
8. Signs or symptoms indicative of active CNS involvement.
9. Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to lymphoma or previous lymphoma treatment.
10. Clinically apparent arrhythmia, or arrhythmias that are not stable on medical management
11. Current participation in or prior participation in a study of an investigational agent or using an investigational device within 2 weeks of the first dose of treatment.
12. Prior monoclonal antibody therapy within 4 weeks prior to study Day 1
13. Prior use of alemtuzumab
14. Prior chemotherapy targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1
15. Uncontrolled active infection requiring systemic therapy.
16. Circulating CD5+ malignant cells identified by peripheral blood flow cytometry present.
17. Active and/or systemic inflammatory or autoimmune diseases.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Senza5 CART5 with standard of care lymphodepletion

Four treatment arms with Standard of Care Lymphodepletion:

Fludarabine 25mg/m2 IV for 3 days Cyclophosphamide 250mg/m2 IV for 3 days

experimental: Senza5 CART5 without standard of care lymphodepletion

Four treatment arms in patients are lymphopenic into the corresponding dose level.

Interventions

Senza5 CART5

The Senza5 CART5 drug product consists of a dual population of engineered autologous T cells: CD5 knockout (KO)cells and CD5KO-CART5 cells

Primary outcome measure

  • Determine the recommended phase 2 dose (RP2D) of Senza5 CART5 cells [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Clinical Protocol and Data Management Office

212-342-5162cancerclinicaltrials@cumc.columbia.edu

Principal Investigator:

Ran Reshef, MD, MSc

University of Pennsylvania - Abramson Caner Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Brittany J Koch - Program Manager, Lymphoma Clinical Research, MPH, CCRP

215-776-5548Brittany.Koch@pennmedicine.upenn.edu

Michael McNicholas - Clinical Trial Nurse, MBA, MSN, OCN, RN

267-804-4081michael.mcnicholas@pennmedicine.upenn.edu

Principal Investigator:

Dr. Stefan K Barta - Assoc. Prof. &amp; Leader, T-Cell Lymphoma Program, MD, MS, MRCP

More Information

Sponsor

Vittoria Biotherapeutics

Last update posted

Nov 10, 2025

Last verified

Jul, 2025

Keywords

  • T Cell Lymphoma
  • Lymphoma
  • CD5KO CART5
  • Senza5 CART

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vittoria Biotherapeutics on 2025-11-10.