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Recruiting NCT06420089

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

Phase I Interventional T Cell Non-Hodgkin Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Senza5 CART5.
Who it may be relevant to
Registry conditions: T Cell Non-Hodgkin Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) to Enhance Immunotherapy Against T Cell Non-Hodgkin Lymphoma (NHL): a First-in-human Phase I Clinical Trial

Overview

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.

Interventions

  • Drug 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 measures

  • Determine the recommended phase 2 dose (RP2D) of Senza5 CART5 cells [Time frame: 12 months]
Secondary outcome measures (9)
  • Determine the safety of Senza5 CART5 cells [Time frame: 12 months]
  • Determine the maximum tolerated dose (MTD) [Time frame: 12 months]
  • Determine the manufacturing feasibility of Senza5 CART5 [Time frame: 12 months]
  • Determine efficacy of Senza5 CART5 [Time frame: 12 months]
  • Determine efficacy of Senza5 CART5 [Time frame: 12 months]
  • Determine efficacy of Senza5 CART5 [Time frame: 12 months]
  • Determine efficacy of Senza5 CART5 [Time frame: 12 months]
  • Determine efficacy of Senza5 CART5 [Time frame: 12 months]
  • Determine efficacy of Senza5 CART5 [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Circulating CD5+ malignant cells identified by peripheral blood flow cytometry present.
  • Active and/or systemic inflammatory or autoimmune diseases.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Columbia University Irving Medical Center — New York
  • University of Pennsylvania - Abramson Caner Center — Philadelphia

Identifiers

NCT: NCT06420089 · VIPER 101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗