NCT06385522

A Clinical Trial in Adults With Non-Hodgkin Lymphoma (NHL), With a Particular Emphasis on Cutaneous T Cell Lymphoma (CTCL), Testing the Safety and Activity of a Novel Drug to Inhibit a Protein Called Tumor Necrosis Factor Receptor 2 That Drives Both Lymphoma Growth and Escape of the Immune System

A Phase 1, First-In-Human, Open-Label, Dose-Escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Intravenous Doses of BITR2101 (Anti-TNFR2) in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma Including Cutaneous and Peripheral T Cell Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Boston Immune Technologies and Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this trial is to learn if a new drug, BITR2101, works to treat non-Hodgkin lymphoma (NHL) in adults, with CTCL patients being sought in particular. The trial also seeks to learn about the safety of this drug. This drug is a protein called an antibody. The drug prevents a molecule called a receptor, named TNFR2, from being made. TNFR2 regulates the immune system and provides important signals to lymphoma cells to grow, make more of themselves and survive. When the drug prevents TNFR2 from being produced in lymphoma cells from CTCL patients, those cells died in the laboratory. Therefore, the trial seeks to enroll CTCL patients in particular, in addition to other subtypes of NHL. When the drug prevents the receptor from being made in certain immune cells, there is increased immune activity. Thus, the trial will test if this drug is a new immune therapy that helps the immune system to keep lymphoma under control. In particular, we want to find out if the amount of lymphoma in the body decreases while taking the drug. Patients with autoimmune diseases are not permitted because of this potential increase in immunity brought on by this drug. Patients should have NHL that has been previously treated, that is getting worse on their current therapy, and their doctors think a new treatment is needed. All patients will receive BITR2101 by a 3 hour infusion into a vein, periodically, initially every 3 weeks. There is no placebo in this trial. Visits to the clinic facility will be required, initially at least every week and later less frequently. Patients will be expected to report changes in their health to the clinic staff including new findings and any change in the status of their lymphoma they may be aware of. Patients can continue to receive BITR2101 for up to a year or until their lymphoma worsens. For patients who are clearly benefiting, they may be able to receive BITR2101 for another year.

Conditions

• NHL
• Cutaneous T Cell Lymphoma
• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	BITR2101	TNFR2 monoclonal antibody

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-06-01
• Completion: 2027-02-01
• First posted: 2024-04-26
• Last updated: 2025-07-08

Regulatory

• FDA-regulated drug study