CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL)

NCT06420089 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: VIPER 101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Keywords

T Cell Lymphoma; Lymphoma; CD5KO CART5; Senza5 CART

Outcome Measures

Primary Outcomes (1)

• Determine the recommended phase 2 dose (RP2D) of Senza5 CART5 cells

  Measure the occurrence of Dose Limiting Toxicity events of each dose level per arm

  12 months

Secondary Outcomes (9)

• Determine the safety of Senza5 CART5 cells

  12 months

• Determine the maximum tolerated dose (MTD)

  12 months

• Determine the manufacturing feasibility of Senza5 CART5

  12 months

• Determine efficacy of Senza5 CART5

  12 months

• Determine efficacy of Senza5 CART5

  12 months

Study Arms (2)

Senza5 CART5 with standard of care lymphodepletion

EXPERIMENTAL

Four treatment arms with Standard of Care Lymphodepletion: Fludarabine 25mg/m2 IV for 3 days Cyclophosphamide 250mg/m2 IV for 3 days

Drug: Senza5 CART5

Senza5 CART5 without standard of care lymphodepletion

EXPERIMENTAL

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

Drug: Senza5 CART5

Interventions

Senza5 CART5 DRUG

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

Senza5 CART5 with standard of care lymphodepletion; Senza5 CART5 without standard of care lymphodepletion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• ≥50% expression of CD5 on flow cytometry or IHC on malignant cells on the most recent biopsy
• 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.
• 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.
• No circulating CD5+ malignant cells identified by peripheral blood flow cytometry must be present.

You may not qualify if:

• Pregnant or lactating (nursing) women.
• HIV infection.
• Concurrent use of systemic steroids or immunosuppressant medications.
• Any uncontrolled active medical disorder that would preclude participation as outlined.
• History of immunodeficiency.
• 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.
• Active and/or systemic inflammatory or autoimmune diseases.
• Signs or symptoms indicative of active CNS involvement.
• 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.
• Clinically apparent arrhythmia, or arrhythmias that are not stable on medical management
• 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.
• Prior monoclonal antibody therapy within 4 weeks prior to study Day 1
• Prior use of alemtuzumab
• Prior chemotherapy targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1
• Uncontrolled active infection requiring systemic therapy.

Sponsors & Collaborators

• Vittoria Biotherapeutics: lead
• University of Pennsylvania: collaborator

Study Sites (2)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

University of Pennsylvania - Abramson Caner Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell; Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Vittoria Biotherapeutics

CONTACT

(215) 600-1380; ClinOps@vittoriabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 17, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2029
• Last Updated: November 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)