BridgeMD
New treatment option for Diffuse Large B-Cell Lymphoma
Official title Study of Loncastuximab Tesirine in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) Following CAR-T Therapy Failure
ClinicalTrials.gov ID: NCT06918912
What this study is testing
What is Loncastuximab Tesirine (Anti-CD19 Antibody-Drug Conjugate)?
Loncastuximab Tesirine (Anti-CD19 Antibody-Drug Conjugate) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse large b-cell 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 trial is to evaluate whether the drug Loncastuximab Tesirine can treat patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) who have not responded to or have had a relapse after CAR-T therapy. The main question it aims to answer is: Can Loncastuximab Tesirine improve the overall response rate (ORR) in patients who have failed CAR-T therapy?
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Male or female patients aged ≥18 years.
- Ability to provide written informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Histologically confirmed diagnosis of one of the following:
- Diffuse large B-cell lymphoma (DLBCL), non-Hodgkin lymphoma, or high grade B-cell lymphoma (HGBCL), including double/triple-hit lymphomas with MYC...
You likely can't join if
- Known hypersensitivity to Loncastuximab Tesirina or any component of the drug.
- Pregnant or breastfeeding women.
- Active second primary malignancy, except for skin cancer, non-metastatic prostate cancer, cervical carcinoma in situ, ductal or lobular carcinoma in...
- Active central nervous system (CNS) involvement, including leptomeningeal disease.
- Tumor mass with a diameter \>10 cm.
- Positive for HIV, hepatitis B (HBV), or hepatitis C (HCV) requiring antiviral treatment.
See the full eligibility criteria
- Male or female patients aged ≥18 years.
- Ability to provide written informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Histologically confirmed diagnosis of one of the following:
- Diffuse large B-cell lymphoma (DLBCL), non-Hodgkin lymphoma, or high grade B-cell lymphoma (HGBCL), including double/triple-hit lymphomas with MYC, BCL2, and/or BCL6 rearrangements.
- Relapsed/refractory disease after prior CAR-T therapy, defined as: Progressive disease (PD) at any time following CAR-T infusion. Partial response (PR) or stable disease (SD) at 3 months post-CAR-T infusion.
- Measurable disease as defined by the Lugano 2014 Classification and confirmed by PET-CT, CT, or MRI scans, as appropriate.
- Previous treatment with Loncastuximab Tesirina is allowed if the patient was in complete response (CR) or partial response (PR) at the time of discontinuation of the drug.
- Negative pregnancy test (β-HCG) for women of childbearing potential, performed within 7 days before the first dose of study drug (C1D1).
- Female patients of childbearing potential must agree to use highly effective contraception from the time of informed consent until at least 9 months after the last dose of Loncastuximab Tesirina. Male patients with...
- Adequate renal, hepatic, pulmonary, and cardiac function: Creatinine clearance ≥40 mL/min. ALT/AST ≤2.5 x ULN. Total bilirubin ≤1.5 x ULN (except for patients with Gilbert's syndrome). LVEF ≥50% (or center-specific...
- Adequate hematologic function: Absolute neutrophil count ≥1.0 × 10⁹/L. Hemoglobin ≥9.0 g/dL. Platelets ≥50 × 10⁹/L.
- Known hypersensitivity to Loncastuximab Tesirina or any component of the drug.
- Pregnant or breastfeeding women.
- Active second primary malignancy, except for skin cancer, non-metastatic prostate cancer, cervical carcinoma in situ, ductal or lobular carcinoma in situ of the breast, or other malignancies that are considered not to...
- Active central nervous system (CNS) involvement, including leptomeningeal disease.
- Tumor mass with a diameter \>10 cm.
- Positive for HIV, hepatitis B (HBV), or hepatitis C (HCV) requiring antiviral treatment.
- Clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion requiring drainage or associated with respiratory distress).
- Significant comorbid conditions, including uncontrolled hypertension (BP ≥160/100 mmHg), unstable angina, congestive heart failure (NYHA class III or IV), recent myocardial infarction or angioplasty within 6 months...
- Active autoimmune disease, motor neuropathy of autoimmune origin, or other autoimmune diseases affecting the central nervous system (CNS).
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
- Recent chemotherapy, radiotherapy, or other anticancer treatments (within 14 days prior to study drug administration, except if approved by the Sponsor).
- Planned administration of a live vaccine after the first dose of study drug (C1D1).
- Use of any experimental drug or therapy within 14 days before the first dose of study drug (C1D1).
- Failure to recover from prior chemotherapy or radiation-related toxicities to ≤Grade 1 (CTCAE v5.0) before screening.
- Any other disease, anomaly, or medical condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study or pose a risk to the patient.
The study team makes the final eligibility decision.
Where it's taking place
- Alessandria, ALESSANDRIA, Italy
- Bologna, BO, Italy
- Cuneo, Cuneo, Italy
- Milan, MILANO, Italy
- Rozzano, MILANO, Italy
- Roma, RO, Italy
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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alessandria, ALESSANDRIA, Italy; Bologna, BO, Italy; Cuneo, Cuneo, Italy; Milan, MILANO, Italy; Rozzano, MILANO, Italy; Roma, RO, Italy. 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.