T Cell Non-Hodgkin LymphomaPhase 1VIPER101NCT06420089
CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL)
A Phase 1 study testing Senza5 CART5 in people with T Cell Non-Hodgkin Lymphoma, run by Vittoria Biotherapeutics at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T Cell Non-Hodgkin Lymphoma
- What is being tested?
- Senza5 CART5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Oct 2024to 30 Aug 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Clinical Protocol and Data Management Office, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu
Ran Reshef, MD, MSc
- Recruiting
University of Pennsylvania - Abramson Caner Center
Philadelphia, Pennsylvania, 19104
Brittany J Koch - Program Manager, Lymphoma Clinical Research, MPH, CCRP, 215-776-5548, Brittany.Koch@pennmedicine.upenn.edu
Michael McNicholas - Clinical Trial Nurse, MBA, MSN, OCN, RN, 267-804-4081, michael.mcnicholas@pennmedicine.upenn.edu
About this study
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
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
- Being tested
- Senza5 CART5
- Keywords
- T Cell Lymphoma, Lymphoma, CD5KO CART5, Senza5 CART
- Medical subject headings
- Lymphoma, T-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senza5 CART5Drug
The Senza5 CART5 drug product consists of a dual population of engineered autologous T cells: CD5 knockout (KO)cells and CD5KO-CART5 cells
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Senza5 CART5 |
| Senza5 CART5 without standard of care lymphodepletion | Experimental | Four treatment arms in patients are lymphopenic into the corresponding dose level. Receives: Drug: Senza5 CART5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (9)
Determine the safety of Senza5 CART5 cells
Quantify quantifying the type and frequency of adverse events
Measured: 12 months
Determine the maximum tolerated dose (MTD)
Quantify the safety and tolerability of the highest dose
Measured: 12 months
Determine the manufacturing feasibility of Senza5 CART5
Quantify the number of product release failures and occurrence of dose failures (inability to meet targeted dose)
Measured: 12 months
Determine efficacy of Senza5 CART5
Measure the objective response rate
Measured: 12 months
Determine efficacy of Senza5 CART5
Measure the complete response rate
Measured: 12 months
Determine efficacy of Senza5 CART5
Measure the best overall response
Measured: 12 months
Determine efficacy of Senza5 CART5
Measure the duration of response
Measured: 12 months
Determine efficacy of Senza5 CART5
Measure the overall survival
Measured: 12 months
Determine efficacy of Senza5 CART5
Measure the progression free survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start4 Oct 2024
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vittoria Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420089
- Sponsor's protocol ID
- VIPER 101
- Acronym
- VIPER101
- Status last verified
- Jul 2025
- First submitted
- 30 Apr 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06420089
- Acronym / sponsor ID
- VIPER101 / VIPER 101
- Conditions
- T Cell Non-Hodgkin Lymphoma
- Keywords
- T Cell Lymphoma, Lymphoma, CD5KO CART5, Senza5 CART
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vittoria BiotherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| Senza5 CART5 with standard of care lymphodepletion | Experimental | Drug: Senza5 CART5Four treatment arms with Standard of Care Lymphodepletion: Fludarabine 25mg/m2 IV for 3 days Cyclophosphamide 250mg/m2 IV for 3 days |
| Senza5 CART5 without standard of care lymphodepletion | Experimental | Drug: Senza5 CART5Four treatment arms in patients are lymphopenic into the corresponding dose level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senza5 CART5The Senza5 CART5 drug product consists of a dual population of engineered autologous T cells: CD5 knockout (KO)cells and CD5KO-CART5 cells | Drug | Senza5 CART5 with standard of care lymphodepletion, Senza5 CART5 without standard of care lymphodepletion |
Primary outcome
Determine the recommended phase 2 dose (RP2D) of Senza5 CART5 cells
Time frame: 12 months
Measure the occurrence of Dose Limiting Toxicity events of each dose level per arm
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Senza5 CART5 in people with T Cell Non-Hodgkin Lymphoma, run by Vittoria Biotherapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vittoria Biotherapeutics ((215) 600-1380, ClinOps@vittoriabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the recommended phase 2 dose (RP2D) of Senza5 CART5 cells (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.