BridgeMD
New treatment option for T Cell Non-Hodgkin Lymphoma
Official title CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL)
ClinicalTrials.gov ID: NCT06420089
What this study is testing
What is Senza5 CART5?
Senza5 CART5 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for t cell non-hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed relapsed or refractory (r/r) CD5-positive nodal peripheral T-cell lymphoma (such as peripheral T-cell...
- ≥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...
- 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...
- No circulating CD5+ malignant cells identified by peripheral blood flow cytometry must be present.
You likely can't join 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...
See the full eligibility 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...
- ≥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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.