Actively Recruiting
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
Led by Istituto Clinico Humanitas · Updated on 2025-04-09
50
Participants Needed
7
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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? * What are the safety and potential side effects of Loncastuximab Tesirine in this patient group? This is a single-arm clinical trial, meaning all participants will receive the same treatment and there will be no comparison group. Researchers will focus on evaluating the effectiveness of the drug in helping patients achieve a response to treatment, and they will also assess the safety of the treatment. Participants will: * Be treated with Loncastuximab Tesirine through an intravenous (IV) infusion every 3 weeks for up to 8 cycles. * Undergo regular assessments to monitor the response to treatment, including PET-CT scans and blood tests to check for markers of the disease. * Be asked to provide informed consent before beginning the study and agree to follow the study procedures, including having biopsies performed to analyze biomarkers before starting treatment. * Be followed for up to 2 years after completing the treatment to track their progress and response. This study aims to help doctors understand if Loncastuximab Tesirine can offer a new treatment option for patients who have not responded to CAR-T therapy and have limited options for further treatment. The trial will also provide more information on how to manage the safety of this treatment for these patients.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Ability to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Histologically confirmed diagnosis of 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 or refractory disease after prior CAR-T therapy, defined as progressive disease at any time following CAR-T infusion, or partial response or stable disease at 3 months post-CAR-T infusion
- Measurable disease confirmed by PET-CT, CT, or MRI scans according to Lugano 2014 Classification
- Previous treatment with Loncastuximab Tesirine allowed if patient was in complete or partial response at discontinuation
- Negative pregnancy test within 7 days before first dose for women of childbearing potential
- Use of highly effective contraception for female patients of childbearing potential from consent until 9 months after last dose
- Use of highly effective contraception for male patients with female partners of childbearing potential from consent until 6 months after last dose
- Adequate renal, hepatic, pulmonary, and cardiac function including creatinine clearance ≥40 mL/min, ALT/AST ≤2.5 x ULN, total bilirubin ≤1.5 x ULN (except Gilbert's syndrome), LVEF ≥50%, oxygen saturation >92% at rest without dyspnea >Grade 1
- Adequate hematologic function with absolute neutrophil count ≥1.0 × 10⁹/L, hemoglobin ≥9.0 g/dL, platelets ≥50 × 10⁹/L
You will not qualify if you...
- Known allergy or hypersensitivity to Loncastuximab Tesirine or its components
- Pregnant or breastfeeding women
- Active second primary cancer except certain skin cancers, non-metastatic prostate cancer, cervical carcinoma in situ, ductal or lobular carcinoma in situ of the breast, or other cancers deemed non-interfering
- Active central nervous system involvement including leptomeningeal disease
- Tumor mass larger than 10 cm in diameter
- Positive for HIV, hepatitis B or C requiring antiviral treatment
- Significant fluid accumulation such as ascites or pleural effusion requiring drainage or causing breathing problems
- Serious health conditions including uncontrolled high blood pressure, unstable angina, severe heart failure, recent heart attack or angioplasty within 6 months, uncontrolled arrhythmia, poorly controlled diabetes, or severe chronic lung disease
- Active autoimmune diseases or motor neuropathy of autoimmune origin affecting the central nervous system
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- Recent chemotherapy, radiotherapy, or other cancer treatments within 14 days before study drug administration unless approved
- Planned live vaccine administration after first study drug dose
- Use of experimental drugs within 14 days before first study drug dose
- Not recovered from previous chemotherapy or radiation toxicities to Grade 1 or less
- Any other medical condition that the investigator believes makes participation unsafe or unsuitable
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Trial Site Locations
Total: 7 locations
1
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, ALESSANDRIA, Italy, 15121
Actively Recruiting
2
Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, BO, Italy, 40138
Actively Recruiting
3
Azienda Sanitaria Ospedaliera Santa Croce e Carle di Cuneo
Cuneo, Cuneo, Italy, 12100
Actively Recruiting
4
Ospedale San Raffaele
Milan, MILANO, Italy, 20132
Actively Recruiting
5
Istituto Nazionale dei Tumori
Milan, MILANO, Italy, 20133
Actively Recruiting
6
Irccs Istituto Clinico Humanitas
Rozzano, MILANO, Italy, 20089
Actively Recruiting
7
AOU Policlinico Umberto I
Roma, RO, Italy, 00161
Actively Recruiting
Research Team
C
Carmelo Carlo-Stella
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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