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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
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
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 moreTrial 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
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.
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Who is running the clinical trial?
Cullinan Oncology, LLCLead Sponsor
6 Previous Clinical Trials
902 Total Patients Enrolled
Cullinan Therapeutics Inc.Lead Sponsor
7 Previous Clinical Trials
672 Total Patients Enrolled
Cullinan Oncology Inc.Lead Sponsor
5 Previous Clinical Trials
618 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious brain or spinal cord condition.I have or had cancer types other than the one I'm seeking treatment for.My lymphoma affects my brain or central nervous system.I do not have any serious infections currently or recently.I have not received any live vaccines recently.I can take care of myself and perform daily activities.My cancer is a type of B-cell neoplasm that is CD19 positive.I have a known heart condition.I have received specific previous treatments.I have received an organ transplant from another person.I have an autoimmune disorder or need ongoing immune suppression.I am following the specific guidelines for pregnancy prevention during the trial.I do not have active Hepatitis C, B, or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Part A Dose Escalation
- Group 2: Part B Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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