Authorised Therapeutic exploratory (Phase II) Patients affected by relapsed/refractory DLBCL or HGBCL failing CAR T-cell therapy

Use of LOncastuximab Tesirine in patients with RElapsed/Refractory Diffuse Large B-Cell LYmphoma (DLBCL) or High Grade B-Cell Lymphoma (HGBCL) who have progressive disease after CAR T-cell treatment - LORELY

EU CTIS ID: 2024-516929-31-00

What this study is testing

Assess the efficacy of loncastuximab tesirine as measured by overall response rate (ORR) in DLBCL and HGBCL patients failing CAR-T cell therapy

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Male or female, aged ≥18 years. 2. Willing and able to give written, informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 4. Histologically confirmed DLBCL or large B cell lymphoma (at last relapse) as defined by the 2016 WHO classification, including one of the following: • DLBCL, Not Otherwise Specified (NOS) • Transformed DLBCL from indolent lymphoma • HGBCL with MYC and BCL2 and/or BCL6 rearrangements (double/triple hit) 5. Patients failing CAR T-cell therapy, defined as: a. Progressive disease (PD) at any time b. Partial Remission (PR) or stable disease (SD) at 3 months after CAR T-cell infusion. 6. Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET)- computed tomography (CT) or by CT or MRI if tumour is not FDG-avid on screening PET-CT. 7. Previous treatment with loncastuximab tesirine is allowed, provided that the patient was in CR or PR at the time of drug withdrawal. 8. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug (C1D1) for women of childbearing potential. 9. Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 9 months after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 6 months after the patient receives his last dose of loncastuximab tesirine. 10. Adequate renal, hepatic, pulmonary, and cardiac function defined as: • Creatinine clearance ≥40 ml/min. • Serum alanine aminotransferase / aspartate aminotransferase ≤2.5 x ULN. • Total bilirubin ≤1.5 x ULN, except in subjects with Gilbert's syndrome. • Known history of LVEF ≥50% unless the institutional lower limit of normal is lower. • Baseline oxygen saturation >92% on room air and ≤Grade 1 dyspnoea. 11. Adequate Bone Marrow (BM) function without requiring ongoing blood product or granulocyte-colony stimulating factor support (GCSF) and meeting the following criteria: • Absolute neutrophil count ≥1.0 × 10^6/dL. • Haemoglobin ≥9.0 g/dL • Platelets ≥50 × 10^6/dL

You likely can't join if

  • 1. Known history of hypersensitivity to or positive serum human antidrug antibody (ADA) to a CD19 antibody. 2. Females who are pregnant or lactating.3. Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary. 4. Lymphoma with active CNS involvement at the time of screening, including leptomeningeal disease. 5. Bulky disease, defined as largest tumour diameter >10 cm. 6. Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV). 7. 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) 8. Significant medical comorbidities, including but not limited to, uncontrolled hypertension (blood pressure ≥160/100 mm Hg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, or severe chronic pulmonary disease. 9. Active autoimmune disease, motor neuropathy considered of autoimmune origin, and other central nervous system (CNS) autoimmune disease. 10. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome. 11. Major surgery, radiotherapy, chemotherapy or other antineoplastic therapy within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor. 12. Planned live vaccine administration after starting study drug (C1D1). 13. Use of any other experimental medication within 14 days prior to start of study drug (C1D1). 14. Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events version 5.0 [CTCAE v5.0]) from acute nonhematologic toxicity (Grade ≤2 neuropathy or alopecia) due to previous therapy prior to screening. 15. Any other significant medical illness, abnormality, or condition that would, in the Investigator’s judgment, make the patient inappropriate for study participation or put the patient at risk.

The study team makes the final eligibility decision.

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, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.