What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, particularly those targeting B-cell malignancies, include monoclonal antibodies (e.g., rituximab), chemotherapy agents (e.g., bendamustine), and targeted therapies (e.g., venetoclax). Known side effects include infusion reactions, which can be severe with rituximab, myelosuppression leading to low blood cell counts and increased infection risk with bendamustine, and tumor lysis syndrome, neutropenia, and gastrointestinal issues with venetoclax. These side effects are critical considerations in treatment planning.

What prior FDA approvals exist?

The FDA has approved several treatments for B-cell Non-Hodgkin's Lymphoma (NHL), including monoclonal antibodies and targeted therapies. Rituximab, an anti-CD20 monoclonal antibody, was one of the first targeted therapies approved and is commonly used in combination with chemotherapy. Other anti-CD20 antibodies like obinutuzumab and ofatumumab have also been approved. Additionally, idelalisib, a PI3K inhibitor, and ibrutinib, a BTK inhibitor, have been approved for relapsed or refractory B-cell NHL. These treatments target specific pathways in B-cell malignancies, similar to the novel therapeutic agent CLN-978 being studied in the trial.

What other types of research exist?

Promising novel alternatives to CLN-978 for Non-Hodgkin's Lymphoma patients include: 1) Venetoclax plus Obinutuzumab, which has shown improved progression-free survival and acceptable tolerability in clinical trials. 2) Zanubrutinib, a BTK inhibitor that has demonstrated efficacy and a favorable safety profile, particularly in patients with comorbidities. 3) Acalabrutinib, another BTK inhibitor, known for its better tolerability compared to Ibrutinib. These therapies offer effective options for patients with relapsed or refractory B-cell NHL.

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Monoclonal Antibodies

CLN-978 for B-Cell Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Cullinan Oncology, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new experimental drug called CLN-978 in patients with a type of cancer that has come back or not responded to other treatments. The drug aims to either attack the cancer cells directly or help the immune system fight the cancer.

Who is the study for?

This trial is for adults with B-cell Non-Hodgkin Lymphoma that has come back or didn't respond to treatment. They must have tried at least two prior therapies and be in fairly good physical shape (ECOG PS ≤ 2). People can't join if they've had certain recent treatments, like CAR-T therapy, organ transplants, or are pregnant. Also excluded are those with autoimmune diseases needing immune suppression, active infections including COVID-19, or significant heart disease.

What is being tested?

The study tests CLN-978 in patients whose B-NHL has relapsed or hasn't responded to other treatments. It's an early-phase trial where researchers first find the best dose of CLN-978 and then see how well it works on different types of this lymphoma.

What are the potential side effects?

While specific side effects for CLN-978 aren’t detailed here, similar cancer drugs often cause fatigue, infusion reactions (like fever or chills), lowered blood cell counts increasing infection risk, nausea, and potential liver issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Define dose regimen for CLN-978

Safety and tolerability of CLN-978 based on AEs, AESIs, and SAEs

Secondary study objectives

Assess preliminary efficacy of CLN-978 by complete response in patients with selective histologies of R/R B-NHL

Assess preliminary efficacy of CLN-978 by duration of response in patients with selective histologies of R/R B-NHL

Assess preliminary efficacy of CLN-978 by overall response in patients with selective histologies of R/R B-NHL

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B Dose ExpansionExperimental Treatment1 Intervention

Patients with R/R DLBCL, R/R FL and other R/R B-NHL treated with CLN-978 at a dose selected from the Part A Dose Escalation arm.

Group II: Part A Dose EscalationExperimental Treatment1 Intervention

Patients with R/R B-NHL treated with CLN-978 in dose escalation cohorts

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL), particularly B-cell malignancies, include monoclonal antibodies, small molecule inhibitors, and CAR-T cell therapy. Monoclonal antibodies, such as rituximab, target specific proteins on the surface of B-cells, leading to their destruction by the immune system. Small molecule inhibitors, like ibrutinib, block key signaling pathways that B-cells need to survive and proliferate. CAR-T cell therapy involves modifying a patient's T-cells to express receptors that specifically target and kill B-cells. These treatments are crucial for NHL patients as they offer targeted approaches that can effectively reduce tumor burden and improve survival rates while potentially minimizing damage to healthy cells.