Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in R/R B-NHL
Research type
Research Study
Full title
A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
IRAS ID
1004155
Contact name
Nadia Bonsu
Contact email
Sponsor organisation
ADC Therapeutics SA
Eudract number
2021-001071-16
Clinicaltrials.gov Identifier
Research summary
Non-Hodgkin lymphoma (NHL) is a cancer of immune system cells called lymphocytes. NHL is the 7th most prevalent form of cancer and tumours of B lymphocyte origin account for 85%-90% of NHL in the US. This study is designed to evaluate the safety and anti-cancer activity of Loncastuximab Tesirine combined with other anti-cancer therapies in patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-NHL). Patients with R/R B-NHL failed or intolerant to any approved therapy and had received at least 2 systemic treatment regimens. Male and female participants 18 years of age and older with R/R B-NHL will participate. This study will enrol approx. 200 participants and has 2 parts. Part 1 may enrol 70 participants. Part 2
may enrol 130 participants. Part 1 of the study will look at escalating doses of gemcitabine (Arm A), lenalidomide (Arm B) and umbralisib (Arm D) with Loncastuximab tesirine respectively. Umbralisib is not marketed in the EU yet, arm D will only be conducted in the United States. Arm C involves the administration of Polatuzumab vedotin with escalating doses of Loncastuximab tesirine. This will determine the maximum tolerated dose and/or recommended dose for expansion of the combinations. Part 2 will aim to retrieve further safety and anti-cancer activity information on the combinations of Loncastuximab tesirine and the above-mentioned anti-cancer therapies. This may have up to 6 cohorts within each arm, each cohort representing a sub-type of B-NHL.. Both parts include a Screening Period (up to 28 days), a Treatment Period (cycles of 3 weeks for up to a year), and a follow-up period (approximately every 12 week visits
for up to two years from end of treatment). The total amount of time participants in the study will depend on how they tolerate the study medication and if their cancer responds well to the treatment. During the study, participants will undergo different procedures including physical and radiological exams, blood sampling etc.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0006
Date of REC Opinion
28 Feb 2022
REC opinion
Further Information Favourable Opinion