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Antineoplastic Agents

Loncastuximab Tesirine Combinations for Non-Hodgkin's Lymphoma

Phase 1
Recruiting
Research Sponsored by ADC Therapeutics S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
FL
Availability of formalin-fixed paraffin-embedded tumor tissue block
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights

Study Summary

This trial is testing the safety and tolerability of loncastuximab tesirine in combination with gemcitabine, lenalidomide, polazutumab vedotin, or umbralisib to find the maximum tolerated dose.

Who is the study for?
Adults with relapsed or refractory B-cell non-Hodgkin Lymphoma who've had at least two prior treatments can join this trial. They must have measurable disease, adequate organ function, and agree to use effective contraception. Exclusions include significant health issues, recent other cancer therapies, live vaccines, certain infections like HIV/HBV/HCV, CNS lymphoma involvement, known drug hypersensitivities.Check my eligibility
What is being tested?
The study tests the safety and anti-cancer effects of Loncastuximab Tesirine combined with Polatuzumab Vedotin, Glofitamab or Mosunetuzumab in patients. It aims to find the highest dose patients can tolerate without severe side effects (MTD) and suggest a dose for further trials (RDE).See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, fatigue, nausea or vomiting. There could also be blood-related issues such as low counts leading to increased infection risk or bleeding problems. Organ inflammation is possible too.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can provide a tissue sample from my tumor.
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My B-cell non-Hodgkin Lymphoma has come back or didn't respond to treatment, and I've tried at least two treatments.
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I am 18 years old or older.
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I have been diagnosed with high-grade B-cell lymphoma.
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I can take care of myself and perform daily activities.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Experience a Clinically Significant Change from Baseline in 12-Lead Electrocardiogram (ECG) Measurements
Number of Participants Who Experience a Clinically Significant Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Number of Participants Who Experience a Clinically Significant Change from Baseline in Safety Laboratory Measurements
+6 more
Secondary outcome measures
Accumulation Index (AI) of Loncastuximab Tesirine
Apparent Clearance (CL) of Loncastuximab Tesirine
Apparent Steady-State Volume of Distribution (Vss) of Loncastuximab Tesirine
+16 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Part 2 (Dose Expansion): Loncastuximab Tesirine + Polatuzumab Vedotin (Arm C)Experimental Treatment2 Interventions
Participants with B-NHL will receive loncastuximab tesirine in combination with polatuzumab vedotin at the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) if favorable results of Part 1 are received.
Group II: Part 2 (Dose Expansion): Loncastuximab Tesirine + Mosunetuzumab (Arm F)Experimental Treatment2 Interventions
Participants with B-NHL will receive loncastuximab tesirine in combination with mosunetuzumab at the MTD and/or RDE if favorable results of Part 1 are received.
Group III: Part 2 (Dose Expansion): Loncastuximab Tesirine + Glofitamab (Arm E)Experimental Treatment3 Interventions
Participants with B-NHL will receive loncastuximab tesirine in combination with glofitamab at the MTD and/or RDE if favorable results of Part 1 are received. In addition participants will receive obinutuzumab pre-treatment 1000 mg on C1 D1.
Group IV: Part 1 (Dose Escalation): Loncastuximab Tesirine + Polatuzumab Vedotin (Arm C)Experimental Treatment2 Interventions
Participants will receive escalating doses (90 µg/kg to 150 µg/kg) of loncastuximab tesirine on Day (D) 1 of each cycle (where each cycle is 21 days). Participants will also receive polatuzumab vedotin at a dose of 1.8 mg/kg on D1 of each cycle, infusion will be started one hour after end of loncastuximab tesirine infusion.
Group V: Part 1 (Dose Escalation): Loncastuximab Tesirine + Mosunetuzumab (Arm F)Experimental Treatment2 Interventions
Participants will receive escalating doses (90 µg/kg to 150 µg/kg) of loncastuximab tesirine on Day (D) 1 of each cycle (where each cycle is 21 days). Participants will also receive mosunetuzumab 5 mg on C1 D1, 45 mg for C1 D8, C1 D15 and cycles 2-8 D1.
Group VI: Part 1 (Dose Escalation): Loncastuximab Tesirine + Glofitamab (Arm E)Experimental Treatment3 Interventions
Participants will receive escalating doses (90 µg/kg to 150 µg/kg) of loncastuximab tesirine on D2 of Cycle (C) 1 and then D1 of all other cycles (where each cycle is 21 days). Participants will also receive glofitamab 2.5 mg on C1 D8, 10 mg on C1 D15 and 30 mg for cycles 2-12 D1. In addition participants will receive obinutuzumab pre-treatment 1000 mg on C1 D1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Loncastuximab Tesirine
2022
Completed Phase 2
~50
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Glofitamab
2021
Completed Phase 1
~60
Mosunetuzumab
2019
Completed Phase 2
~140
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

ADC Therapeutics S.A.Lead Sponsor
28 Previous Clinical Trials
2,097 Total Patients Enrolled

Media Library

Gemcitabine (Antineoplastic Agents) Clinical Trial Eligibility Overview. Trial Name: NCT04970901 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Part 2 (Dose Expansion): Loncastuximab Tesirine + Glofitamab (Arm E), Part 2 (Dose Expansion): Loncastuximab Tesirine + Mosunetuzumab (Arm F), Part 1 (Dose Escalation): Loncastuximab Tesirine + Mosunetuzumab (Arm F), Part 2 (Dose Expansion): Loncastuximab Tesirine + Polatuzumab Vedotin (Arm C), Part 1 (Dose Escalation): Loncastuximab Tesirine + Polatuzumab Vedotin (Arm C), Part 1 (Dose Escalation): Loncastuximab Tesirine + Glofitamab (Arm E)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT04970901 — Phase 1
Gemcitabine (Antineoplastic Agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04970901 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current sample size of participants for this investigation?

"The sponsor, ADC Therapeutics S.A., will be launching this medical trial in multiple locations including Avera Cancer Institute and Emily Couric Clinical Cancer Center. To commence the study, 200 eligible participants are needed to meet the established inclusion criteria."

Answered by AI

Are there antecedent endeavors regarding Loncastuximab Tesirine?

"Currently, Loncastuximab Tesirine has 740 active investigational trials with 194 of them in the final stage. Clinical sites are available all around the world but Woolloongabba, Queensland is a particularly popular location for research into this drug; 38501 studies have been conducted there alone."

Answered by AI

What potential health risks have been identified with Loncastuximab Tesirine?

"The safety profile of Loncastuximab Tesirine was estimated to be a score of 1 out of 3, as this is an initial research trial with limited data on efficacy and risk."

Answered by AI

In what medical circumstances is Loncastuximab Tesirine typically administered?

"Loncastuximab Tesirine is regularly utilized to treat chronic lymphocytic leukemia, as well as various other maladies such as urinary bladder cancer and diffuse large B-cell lymphoma after two prior systemic chemotherapies."

Answered by AI

Are there numerous locations implementing this clinical trial in North America?

"Currently, 6 medical sites are recruiting participants for this trial. These include Sioux Falls, Charlottesville and Charleston among others. To reduce transportation needs during the course of your participation in the study, we recommend selecting a clinic close to you."

Answered by AI

Are there any recruitment opportunities for this trial presently?

"As indicated on the clinicaltrials.gov website, enrollment for this trial is still open. It was first announced on June 17th 2022 and has been amended as recently as July 22nd 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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)
2022. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04970901.
~58 spots leftby Feb 2025
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