BridgeMD
New treatment option for Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
Official title Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas
ClinicalTrials.gov ID: NCT04288726
What this study is testing
What is CD30.CAR-EBVST cells?
CD30.CAR-EBVST cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for extranodal natural killer/t-cell lymphoma, nasal type.
Also referred to as Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes.
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 study involved patients that have a cancer called diffuse large B cell lymphoma (DLBCL), NK and T cell lymphomas (NK/TL) or classical Hodgkin lymphoma (cHL) (hereafter these 3 diseases will be referred to as lymphoma). Patients lymphoma has come back or not gone away after treatment.
- 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 12 to 75
You may be able to join if
- Diagnosis and clinical course falling into one of the following categories:
- Hodgkin lymphoma
- Aggressive non-Hodgkin lymphoma
- ALK-negative anaplastic T cell lymphoma or other peripheral T-cell lymphoma
- ALK-positive anaplastic T cell lymphoma
You likely can't join if
- Received an investigational cell therapy or vaccine within the past 6 weeks.
- Received an investigational small molecule drug within the past 2 weeks.
- Received CD30 antibody-based therapy within the previous 4 weeks.
- Received gemcitabine-containing chemotherapy within the previous 12 weeks
- History of hypersensitivity reactions to murine protein-containing products.
- Pregnant or lactating.
See the full eligibility criteria
- Diagnosis and clinical course falling into one of the following categories:
- Hodgkin lymphoma
- Aggressive non-Hodgkin lymphoma
- ALK-negative anaplastic T cell lymphoma or other peripheral T-cell lymphoma
- ALK-positive anaplastic T cell lymphoma
- CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.
- Age 12 to 75.
- Bilirubin 2 times (or 3 times if the patient has Gilbert syndrome) or less than the upper limit of normal.
- AST 3 times or less than the upper limit of normal.
- Estimated GFR \> 70 mL/min.
- Pulse oximetry of \> 90% on room air
- EKG shows no significant arrhythmias
- Karnofsky or Lansky score of \> 60%.
- Available allogeneic T cells with ≥15% expression of CD30CAR determined by flow-cytometry.
- Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
- Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form.
- Received an investigational cell therapy or vaccine within the past 6 weeks.
- Received an investigational small molecule drug within the past 2 weeks.
- Received CD30 antibody-based therapy within the previous 4 weeks.
- Received gemcitabine-containing chemotherapy within the previous 12 weeks
- History of hypersensitivity reactions to murine protein-containing products.
- Pregnant or lactating.
- Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion).
- Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg/day of prednisone.
- Active significant, uncontrolled bacterial, viral or fungal infection.
- Symptomatic cardiac disease (NYHA Class III or IV disease).
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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, 12 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.