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

Launched by BOSTON IMMUNE TECHNOLOGIES AND THERAPEUTICS · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called BITR2101 to see if it can help treat a type of cancer known as non-Hodgkin lymphoma (NHL), particularly focusing on patients with cutaneous T cell lymphoma (CTCL). The goal is to find out if this drug is safe and effective. BITR2101 works by blocking a protein that helps lymphoma cells grow and escape the immune system. In laboratory tests, this drug has shown promise in killing lymphoma cells. The trial aims to find out if patients experience a decrease in their lymphoma while receiving this treatment.

To participate in the trial, patients must be at least 18 years old and have a specific type of NHL that has not responded well to previous treatments. They should have a life expectancy of at least three months and be in relatively good health. Participants will receive BITR2101 through an infusion into a vein every three weeks, with regular clinic visits to monitor their health and any changes in their lymphoma. While there is no placebo in this trial, patients who benefit from the drug may be able to continue treatment for up to two years. It’s important to note that patients with certain autoimmune diseases or serious health issues may not be eligible for this study.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Histologically confirmed relapsed or refractory B cell NHL (DLBCL, MCL, MZL), PTCL or CTCL (MF or SS subtype) as per 2017 World Health Organization classification after at least 2 prior lines of systemic therapy and have received, or are not eligible for, approved or available treatments expected to provide benefit. CTCL patients should be Stage ≥1B through 4 and Stage 1A (see Appendix 1) with plaque disease without treatment options, in which case the patient should be discussed with the sponsor after submitting documentation of disease stage and treatment history. Patients with indolent lymphoid malignancies (CTCL, MZL) must need new treatment regimen in the opinion of the treating Investigator.
• • Age ≥18 years.
• • Life expectancy ≥3 months.
• • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Key Exclusion Criteria:
• • Patients with prior exposure (up to 12 months) to PD-1/PD-L1 therapies.
• • Known hypersensitivity to any excipients that are used in the BITR2101 formulation as noted in Investigator Brochure.
• • Autoimmune diseases that have been sufficiently active to require medications in the 3 months before screening, except autoimmune endocrinopathies, such as hypothyroidism, that are stable with hormone-replacement therapy. Including inflammatory diseases such as arthritis, colitis, liver fibrosis, cirrhosis, interstitial fibrosis or chronic obstructive pulmonary disease (COPD). The SRC may allow patients with well controlled arthritis or COPD in the expansion cohort if there is no indication of inflammatory disease flare and no blood cytokine evidence of a systemic inflammatory response in the 3 months prior to enrollment.
• • Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with participating in the protocol.
• • History or evidence of clinically significant cardiovascular disease.
• • Severe dyspnea, pulmonary dysfunction, or need for continuous supportive oxygen inhalation.
• • Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study for the duration of this study or the FU period of an interventional study.
• • Prior or current anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy within 4 weeks of the first BITR2101 administration.
• • Continuous corticosteroid use exceeding 10 mg/day prednisone or equivalent.
• • Other protocol defined Inclusion/Exclusion criteria may apply