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New treatment option for Recurrent Diffuse Large B-Cell Lymphoma
Official title Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
ClinicalTrials.gov ID: NCT05672251
What this study is testing
What is Loncastuximab Tesirine?
Loncastuximab Tesirine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent diffuse large b-cell lymphoma.
Also referred to as ADC ADCT-402, ADCT-402.
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 phase II trial studies the safety and how well of loncastuximab tesirine when given together with mosunetuzumab works in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, loncastuximab, linked to a toxic agent called tesirine.
- 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
- Documented informed consent of the participant and/or legally authorized representative.
- Assent, when appropriate, will be obtained per institutional guidelines.
- Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy...
- If unavailable, exceptions may be granted with study principal investigator (PI) approval.
- Age: \>= 18 years.
You likely can't join if
- Prior treatment with loncastuximab tesirine.
- Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies.
- Prior allogeneic stem cell transplantation.
- Prior use of any monoclonal antibody, radioimmunoconjugate or ADC within 2 weeks prior to Day 1 of protocol therapy.
- Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks or 5...
- Treatment with radiotherapy within 2 weeks prior to Day 1 of protocol therapy.
See the full eligibility criteria
Who can join
- Documented informed consent of the participant and/or legally authorized representative.
- Assent, when appropriate, will be obtained per institutional guidelines.
- Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy or from diagnostic tumor biopsies.
- If unavailable, exceptions may be granted with study principal investigator (PI) approval.
- Age: \>= 18 years.
- Eastern Cooperative Oncology Group (ECOG) =\< 2.
- Histologically confirmed diagnosis of diffuse large B-cell lymphoma or Follicular Lymphoma Grade 3B according to the World Health Organization (WHO) classification, with hematopathology review at the participating...
- Life expectancy \> 12 months.
- Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma Grade 3B according to the WHO classification, with hematopathology review at the participating institution. Subtypes of...
- Relapsed or refractory disease after \>= 1 prior line of therapy (prior CD19-directed therapy and prior autologous stem cell transplant are allowed).
- Relapse at the time of study enrollment must have been confirmed histologically (with hematopathology review at the participating institution). Exceptions may be granted with study PI approval.
- Measurable disease by computerized tomography (CT) or positron emission tomography (PET)/CT scan with one or more sites of disease \>= 1.5 cm in longest dimension.
- Tumor must be positive for both CD19 and CD20 by immunohistochemistry after the most recent therapy.
- Fully recovered from the acute toxic effects (except alopecia) to =\< Grade 1 to prior anti-cancer therapy
- Without bone marrow involvement: Absolute neutrophil count (ANC) \>= 1,000/mm\^3.
- (G-CSF is allowed to reach ANC requirement).
- With bone marrow involvement: no minimum ANC requirement.
- (G-CSF is allowed to reach ANC requirement).
- Platelets \>= 75,000/mm\^3.
- Total bilirubin =\< 1.5 X upper limit of normal (ULN).
- If hepatic involvement by lymphoma, or Gilbert's disease: =\< 3X ULN.
- Aspartate aminotransferase (AST) =\< 2.5 x ULN.
- If hepatic involvement by lymphoma: AST =\< 5 x ULN.
- Alanine aminotransferase (ALT) =\< 2.5 x ULN.
- If hepatic involvement by lymphoma: ALT =\< 5 x ULN .
- Creatinine clearance of \>= 40 mL/min per 24 hour urine test or the Cockcroft-Gault formula
- If not receiving anticoagulants: International Normalized Ratio (INR) OR Prothrombin (PT) =\< 1.5 x ULN.
- If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants.
- If not receiving anticoagulants: Activated Partial Thromboplastin Time (aPTT) =\< 1.5 x ULN
- If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants.
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Agreement by females of childbearing potential to abstain from heterosexual intercourse or use two adequate method of birth control, including at least 1 method with a failure rate of \< 1% per year, for at least 28...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) with no identified cause other than menopause.
- Examples of non-hormonal contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, established and proper use of progestogen only hormonal contraceptives that...
What rules you out
- Prior treatment with loncastuximab tesirine.
- Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies.
- Prior allogeneic stem cell transplantation.
- Prior use of any monoclonal antibody, radioimmunoconjugate or ADC within 2 weeks prior to Day 1 of protocol therapy.
- Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks or 5 half-lives of the drug, whichever is shorter, prior to Day 1 of protocol...
- Treatment with radiotherapy within 2 weeks prior to Day 1 of protocol therapy.
- If patients have received radiotherapy within 4 weeks prior to prior to Day 1 of protocol therapy, patients must have at least one measurable lesion outside of the radiation field. Patients who have only one measurable...
- Autologous stem cell transplantation (SCT) within 30 days prior to prior to Day 1 of protocol therapy.
- Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to Day 1 of protocol therapy.
- Live vaccine within 30 days prior to Day 1 of protocol therapy.
- Concomitant investigational therapy.
- Treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents(e.g., immune checkpoint inhibitor therapies). Note: For certain prior treatments, such as CAR-T cell therapies, patients...
- Systemic steroid therapy or any other form of immunosuppressive therapy for lymphoma symptom control must be tapered down to =\< 20 mg/day prednisone or equivalent. Exceptions are:
- Inhaled or topical steroids
- Use of mineralocorticoids for management of orthostatic hypotension
- Use of physiologic doses of corticosteroids for management of adrenal insufficiency
- Known hypersensitivity to biopharmaceutical produced in chinese hamster ovary (CHO) cells or history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents.
- Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).
- History of solid organ transplantation.
- History of progressive multifocal leukoencephalopathy (PML).
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
- Clinically significant uncontrolled illness.
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment.
- Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with past HBV infection (defined as negative hepatitis B surface antigen [HBsAg] and positive hepatitis B core antibody [HBcAb]) are...
- Known active human immunodeficiency virus (HIV) infection. people who have an undetectable or unquantifiable HIV viral load with CD4 \> 200 and are on HAART medication are allowed. Testing to be done only in patients...
- Known or suspected chronic active Epstein-Barr virus (EBV) infection.
- Known active central nervous system (CNS) involvement by lymphoma, including leptomeningeal involvement.
- History of erythrema multiforme, Grade \>= 3 rash, or blistering following prior treatment with immunomodulatory derivatives.
- Symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), cerebrovascular event/stroke or myocardial infarction within the past 6...
- Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis.
- Active autoimmune disease requiring treatment.
- History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis...
- Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
- Patients with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases may be eligible.
- Recent major surgery (within 4 weeks) prior to start of protocol therapy, other than for diagnosis.
- History of another primary malignancy that has not been in remission for at least 2 years, with the following exceptions:
- Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease
- Adequately treated in situ carcinomas (e.g. cervical, esophageal) without evidence of disease
- Asymptomatic prostate cancer managed with a watch-and-wait strategy
- If the malignancy is expected to not require any treatment for at least 2 years (this exception should be discussed with the study PI).
- Females only: Pregnant or breastfeeding.
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, 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 Duarte, California, 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.