NCT05053659

Loncastuximab Tesirine and Venetoclax for Relapsed/ Refractory Non-Hodgkin Lymphoma

Phase I Trial of Loncastuximab Tesirine and Venetoclax for Treatment of Relapsed/ Refractory Non-Hodgkin Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Paolo Caimi, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the correct dose and safety of combining two new cancer drugs, loncastuximab tesirine and venetoclax, as a treatment for relapsed or refractory B cell lymphoma.These drugs are used to treat some lymphomas, but have not yet been tested in combination for the treatment of lymphoma. The main goal of this study is to determine the safety of the combination.

Detailed description

This is a phase I trial designed to evaluate the safety and tolerability of loncastuximab tesirine given in combination with venetoclax for treatment of relapsed/refractory non - Hodgkin lymphoma. Loncastuximab tesirine is an investigational (experimental) drug that works by targeting a protein in cancer cells (called CD19) and delivering a small amount of chemotherapy directly to the cancer cells. Loncastuximab tesirine is experimental because it is not approved by the Food and Drug Administration (FDA). Venetoclax, is a targeted anti-cancer drug, which works by imitating a particular protein produced by the tumor and interrupting its normal processes, ultimately causing the tumor cells to die. Adding venetoclax to the loncastuximab tesirine regimen is believed to increase the chance of getting relapsed or refractory B cell lymphoma cancer in remission. Venetoclax is approved by the FDA for treatment in some types of cancer, but is not approved by the FDA for the treatment of lymphoma soit is considered experimental in this study. Up to 36 subjects will take in this phase I research study. The primary objective for this study: To determine the safety and tolerability of the combination of loncastuximab tesirine and venetoclax to identify the recommended phase 2 dose (RP2D) of these agents. Secondary objectives are: * To describe the adverse event profile of the combination of loncastuximab tesirine and venetoclax. * To describe the overall response rate (ORR) and complete response rate (CRR) of relapsed/refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax. * To describe the overall survival (OS) and progression free survival (PFS) of subjects with relapsed / refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax. * To describe the disease-free survival, the disease specific survival and time to treatment failure of subjects with relapsed/refractory non-Hodgkin lymphoma treated with the combination of loncastuximab tesirine and venetoclax.

Conditions

• Relapsed Non Hodgkin Lymphoma
• Refractory Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Loncastuximab tesirine	Loncastuximab tesirine 50 - 150 μg/kg will be administered as a 30 minutes IV infusion on Day 1 of each cycle for 6 cycles. On doses over 100 μg/kg, subsequent dosing (i.e. beyond 100 μg/kg) will be done at 50% of the dose that is administered on the first 2 cycles.
DRUG	Venetoclax	Participants will receive venetoclax at target doses of 400 - 800mg orally on days 1 - 5 of each (21 day) cycle. On cycle 1, venetoclax dose will be escalated to reach the target dose over the course of 5 days for target dose 400mg, 6 days for target dose 600mg and 7 days for target dose 800mg Venetoclax should preferably be given after a meal and on cycle 1 should be preceded by prophylaxis for tumor lysis syndrome (TLS).

Timeline

• Start date: 2022-06-20
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2021-09-22
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study