A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination … (NCT04970901) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
United States, Belgium, Czechia154 participantsStarted 2022-06-17
Plain-language summary
The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab, and to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combinations.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female participant aged 18 years or older
* Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) B-NHL (2016 World Health Organization classification) who have failed, or been intolerant to any approved therapy and had received at least two systemic treatment regimens in Part 1; and at least one systemic treatment regimen in Part 2
* LBCL:
Part 2 Arm E enrollment focused on LBCL only
* DLBCL, not otherwise specified (NOS)
* Germinal Center B-cell type
* Activated B-cell type
* Transformed FL (note: patients with transformed FL must have received at least one line of systemic therapy post-transformation to be eligible)
* HGBCL, with MYC and BCL2 and/or BCL6 rearrangements
* HGBCL, NOS
* FL Grade 3b
* Arm F and Part 1 Arm E:
* All LBCL histologies listed above
* FL (Grade 1-3a)
* MZL
* For Arm C only:
* All histologies listed above
* DLBCL (including transformed diseases)
* MCL
* BL
* Life expectancy of at least 24 weeks according to Investigator's judgement
* Need of systemic treatment for any of the listed indications as assessed by the investigator, including indolent B-NHLs (e.g. FL and MZL)
* Measurable disease as defined by the 2014 Lugano Classification
* Availability of formalin-fixed paraffin-embedded tumor tissue block
* ECOG performance status 0 to 2
* Adequate organ function
* Women of childbearing potential (WOCBP) mu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
Timeframe: Day 1 to Day 21 of Cycle 1, where a cycle is 21 days
2
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Timeframe: Up to approximately 2 years for Arm C and 3 years for Arms E and F
3
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Delay
Timeframe: Up to approximately 1 year
4
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Interruption
Timeframe: Up to approximately 1 year
5
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Reduction
Timeframe: Up to approximately 1 year
6
Number of Participants Who Experience a Clinically Significant Change from Baseline in Safety Laboratory Measurements