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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)

ConditionsB-Cell Non-Hodgkin LymphomaRelapsed B-Cell Non-Hodgkin LymphomaRefractory B-Cell Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorADC Therapeutics S.A.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

DLBCL, not otherwise specified (NOS)

Germinal Center B-cell type

Disqualifiers

Known history of hypersensitivity resulting in treatment discontinuation to or positive serum human ADA to a CD19 antibody

Previous therapy with loncastuximab tesirine

Previous treatment with polatuzumab vedotin, glofitamab or mosunetuzumab (applied to relevant arm and/or cohort of the specific drug administered)

Participants who received previous treatment of polatuzumab vedotin containing regimen will be excluded from Arm C

Trial design

Design model

Sequential

Treatments tested in this trial

  • Loncastuximab Tesirine

    Drug

    Intravenous (IV) infusion

  • Polatuzumab Vedotin

    Drug

    IV infusion

  • Glofitamab

    Drug

    IV infusion

  • Mosunetuzumab

    Drug

    Subcutaneous (SC) injection

  • Obinutuzumab

    Drug

    IV infusion

Treatment groups

200 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part 1 (Dose Escalation): Loncastuximab Tesirine + Polatuzumab Vedotin (Arm C)Experimental treatment 2 interventions
Group B: Part 1 (Dose Escalation): Loncastuximab Tesirine + Glofitamab (Arm E)Experimental treatment 3 interventions
Group C: Part 1 (Dose Escalation): Loncastuximab Tesirine + Mosunetuzumab (Arm F)Experimental treatment 2 interventions
Group D: Part 2 (Dose Expansion): Loncastuximab Tesirine + Polatuzumab Vedotin (Arm C)Experimental treatment 2 interventions
Group E: Part 2 (Dose Expansion): Loncastuximab Tesirine + Glofitamab (Arm E)Experimental treatment 3 interventions
Group F: Part 2 (Dose Expansion): Loncastuximab Tesirine + Mosunetuzumab (Arm F)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)

Time frame
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)

Frequency and severity of TEAEs and treatment-emergent serious adverse events (TESAEs). TEAEs and TESAEs will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Time frame
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

Time frame
Up to approximately 1 year
4

Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Interruption

Time frame
Up to approximately 1 year

Secondary outcomes

1

Complete Response Rate (CRR)

Time frame
Up to approximately 2 years for Arm C and 3 years for Arms E and F
2

Overall Response Rate (ORR)

Time frame
Up to approximately 2 years for Arm C and 3 years for Arms E and F
3

Duration of Response (DOR)

Time frame
Up to approximately 2 years for Arm C and 3 years for Arms E and F
4

Progression-Free Survival (PFS)

Time frame
Up to approximately 2 years for Arm C and 3 years for Arms E and F

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ADC Therapeutics S.A.

Lead sponsor

Source ClinicalTrials.gov
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