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Monoclonal Antibodies

CLN-978 for B-Cell Lymphoma

Phase 1

Recruiting

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

Study Summary

This trial tests a new drug for people with advanced B-cell Non-Hodgkin Lymphoma to see if it can help them.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Define dose regimen for CLN-978

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

Secondary outcome measures

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cullinan Oncology, LLCLead Sponsor

6 Previous Clinical Trials

962 Total Patients Enrolled

Cullinan Therapeutics Inc.Lead Sponsor

6 Previous Clinical Trials

708 Total Patients Enrolled

Cullinan Oncology Inc.Lead Sponsor

5 Previous Clinical Trials

678 Total Patients Enrolled

Media Library

CLN-978 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05879744 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: Part A Dose Escalation, Part B Dose Expansion

Non-Hodgkin's Lymphoma Clinical Trial 2023: CLN-978 Highlights & Side Effects. Trial Name: NCT05879744 — Phase 1

CLN-978 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05879744 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative currently seeking participants?

"Data on clinicaltrials.gov indicates that this medical trial is not actively recruiting patients, having been originally posted on June 15th 2023 and last edited May 18th 2023. Nonetheless, there are a considerable number of other trials enrolling participants as we speak - 1765 to be precise."

Answered by AI

Is this medical research being conducted in multiple locations within the city?

"Currently, the research is recruiting patients at 5 sites across the nation. These places are found in Duarte, Atlanta and Boston to name a few of them. It may be beneficial to choose the closest clinic if you decide to take part so that travelling time can be reduced."

Answered by AI

Has the Part A Dose Escalation protocol been sanctioned by the FDA?

"We rate Part A Dose Escalation's safety on a scale from 1 to 3, assigning it a value of 1 due to its Phase 1 nature. This rating considers the limited amount of data available for efficacy and safety assessment."

Answered by AI

What are the primary aims of this medical study?

"This 24-month clinical trial's objective is to solidify the dosing schedule for CLN-978. Secondary goals entail evaluating the initial efficacy of CLN-978 by complete response in patients with certain subtypes of relapsed/refractory B-cell non-Hodgkin lymphoma, ascertaining preliminary effectiveness through duration of response among these same patient populations, and selecting pharmacokinetic parameters such as area under concentration time curve (AUC)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of CLN-978 in Patients With Relapsed or Refractory (R/R) B Cell Non-Hodgkin Lymphoma (B-NHL)

2023. "A Study of CLN-978 in Patients With Relapsed or Refractory (R/R) B Cell Non-Hodgkin Lymphoma (B-NHL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05879744.