BridgeMD
New treatment option for Recurrent B-Cell Non-Hodgkin Lymphoma
Official title Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT07283679
What this study is testing
What is ONC-PluReceptor NK cells?
ONC-PluReceptor NK cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for recurrent b-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
- The goal of this clinical research study is to learn if ONC-PluReceptor NK cell therapy (combined with the monoclonal antibody therapies epcoritamab and tafasitamab) can help to control relapsed or refractory B-cell Non-Hodgkin Lymphoma. The safety of this treatment will also be studied.
- Phase 2: a mid-size study of how well it works
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
- Patients with R/R DLBCL or FL with all of the following: Failure of \>/= 2 prior lines of therapy, or an autologous or allogeneic stem cell...
- Tumor biopsy positive for CD19 or CD20 at \>/= 1% by immunohistochemistry or flow cytometry.
- Age 18-80 years.
- Karnofsky performance status \>/=60%.
- Absolute neutrophil count \>/=500/mm3 and platelet count \>/=50,000/mm3.
You likely can't join if
- Lymphoma in CR with no measurable sites of disease.
- Major surgery \<4 weeks prior to first dose of study drug.
- Any other severe or uncontrolled disease or condition that might increase the risk associated with study participation.
- Any other malignancy known to be active, with the exception of treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.
- Grade \>/= 3 non-hematologic toxicity from prior therapy that has not improved to grade \</= 2.
- Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA.\>/=10,000 copies/mL, or \>/=2,000 IU/mL), or hepatitis C (detectable viral...
See the full eligibility criteria
- Patients with R/R DLBCL or FL with all of the following: Failure of \>/= 2 prior lines of therapy, or an autologous or allogeneic stem cell transplant. Prior failure of CAR-T or not eligible for CAR-T cells.
- Tumor biopsy positive for CD19 or CD20 at \>/= 1% by immunohistochemistry or flow cytometry.
- Age 18-80 years.
- Karnofsky performance status \>/=60%.
- Absolute neutrophil count \>/=500/mm3 and platelet count \>/=50,000/mm3.
- Serum creatinine clearance (CrCl) \>/=30 ml/min, estimated using the Cockcroft-Gault equation: Estimated creatinine clearance = (140-age [years]) x weight (kg) (x Fa) / serum creatinine (mg/dL) x 72 [a where F=0.85 for...
- Adequate hepatic function (ALT and/or AST \</=3 x upper limit of normal (ULN); bilirubin and ALP \</=2 x ULN). Patients with cancer involvement of the liver and elevation of ALT, AST, bilirubin, and/or ALP \</= 5 x ULN...
- Adequate pulmonary function with FEV1, FVC and DLCO (corrected for hemoglobin and volume) \>/=50%.
- Adequate cardiac function with left ventricular ejection fraction \>/=40%, and no uncontrolled arrhythmias or symptomatic cardiac disease.
- If female of child-bearing potential, she must not be pregnant or breastfeeding and required to have a negative urine or serum pregnancy test prior to enrollment.
- Female participants of non-childbearing potential must meet at least one of the following criteria: i. Postmenopausal (no menses in greater than or equal to 12 consecutive months). ii. History of hysterectomy or...
- Agree to sign the consent to the long-term follow-up protocol PA17-0843 to fulfill the institutional responsibilities to various regulatory agencies
- Lymphoma in CR with no measurable sites of disease.
- Major surgery \<4 weeks prior to first dose of study drug.
- Any other severe or uncontrolled disease or condition that might increase the risk associated with study participation.
- Any other malignancy known to be active, with the exception of treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.
- Grade \>/= 3 non-hematologic toxicity from prior therapy that has not improved to grade \</= 2.
- Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA.\>/=10,000 copies/mL, or \>/=2,000 IU/mL), or hepatitis C (detectable viral load by HCV RNA PCR)
- Active infection requiring parenteral antibiotics.
- HIV infection.
- Treatment within prior 2 weeks with any anti-cancer agent, investigational or approved.
- Active central nervous system (CNS) involvement (untreated parenchymal brain metastasis or positive cytology of cerebrospinal fluid).
- Life expectancy \</= 6 months.
- Active and uncontrolled neurological disorder.
- Patients receiving systemic steroid therapy at the time of enrollment (physiological substitutive doses are allowed), or have received antithymocyte globulin or lymphocyte immune globulin within 14 days of enrollment or...
- Patients receiving immunosuppressive therapy.
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, 18 years and older. 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.