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)

Conditions

• B-Cell Non-Hodgkin Lymphoma
• Refractory B-Cell Non-Hodgkin Lymphoma
• Relapsed B-Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Loncastuximab Tesirine — DRUG
  Intravenous (IV) infusion
• Polatuzumab Vedotin — DRUG
  IV infusion
• Glofitamab — DRUG
  IV infusion
• Mosunetuzumab — DRUG
  Subcutaneous (SC) injection
• Obinutuzumab — DRUG
  IV infusion

Study Details

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.

Key Dates

Start date

Jun 17, 2022

Status verified

Jun 2026

Primary completion

Oct 30, 2026

Completion

Oct 29, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 (Dose Escalation): Loncastuximab Tesirine + Polatuzumab Vedotin (Arm C)
  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.
• Experimental: Part 1 (Dose Escalation): Loncastuximab Tesirine + Glofitamab (Arm E)
  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.
• Experimental: Part 1 (Dose Escalation): Loncastuximab Tesirine + Mosunetuzumab (Arm F)
  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.
• Experimental: Part 2 (Dose Expansion): Loncastuximab Tesirine + Polatuzumab Vedotin (Arm C)
  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.
• Experimental: Part 2 (Dose Expansion): Loncastuximab Tesirine + Glofitamab (Arm E)
  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.
• Experimental: Part 2 (Dose Expansion): Loncastuximab Tesirine + Mosunetuzumab (Arm F)
  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.

Primary Outcome Measure

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 ]

Central Contacts

• Contact ADC Therapeutics
  954-903-7994
  [email protected]

Locations (25)

Find similar trials in Clovis, CA

Related Studies

• A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma
  PHASE1 · Recruiting · Mayo Clinic · Scottsdale, Arizona
• CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies
  PHASE1 · Recruiting · Mayo Clinic · Rochester, Minnesota
• Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
  PHASE1 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
• Long-Term Follow-up Study
  Enrolling By Invitation · Caribou Biosciences, Inc. · Birmingham, Alabama