- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05879744
A Study of CLN-978 in Patients With Relapsed or Refractory (R/R) B Cell Non-Hodgkin Lymphoma (B-NHL)
February 28, 2024 updated by: Cullinan Oncology Inc.
A Phase 1, Open-label, Dose Escalation and Dose Expansion Study of CLN-978 in Patients With Relapsed/Refractory (R/R) B-cell Non-Hodgkin Lymphoma (B-NHL)
CLN-978-001 is a Phase 1, open-label, dose escalation and dose expansion study of CLN-978 in patients with Relapse/Refractory (R/R) B-cell Non-Hodgkin Lymphoma (B-NHL).
Study Overview
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maria Akhondzadeh
- Phone Number: +1 617 410 4650
- Email: ClinOps@cullinanoncology.com
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Recruiting
- University of Alabama at Birmingham
-
Contact:
- Mayur Narkhede, MD
-
-
California
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope
-
Contact:
- Geoffrey Shouse, MD
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Winship Cancer Institute at Emory University
-
Contact:
- Kristie Blum, MD
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Erika Haydu, MD
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- Hackensack University Medical Center
-
Contact:
- Sharon Dailey
-
Principal Investigator:
- Andrew Ip, MD
-
-
Texas
-
Dallas, Texas, United States, 75390
- Recruiting
- University of Texas Southwestern Medical Center
-
Contact:
- Farrukh Awan, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) PS ≤ 2
Documented diagnosis of one of the below CD19+ B-cell neoplasms according to WHO classification (Swerdlow et al., 2016) or WHO classification 2008:
- Diffuse large B-cell lymphoma - de novo or transformed
- High-grade B-cell lymphoma
- Primary mediastinal large B-cell lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Marginal zone lymphoma (nodal, extranodal, or mucosa-associated)
- Relapsed, progressive, and/or refractory disease after at least 2 lines of therapy.
For Part B expansion cohorts:
- Cohort B1: R/R DLBCL that has relapsed after at least 2 prior therapies including a CD20 monoclonal antibody and anthracycline.
- Cohort B2: R/R FL (grade 1-3a) that has relapsed after at least 2 prior therapies including CD20 monoclonal antibody and an alkylating agent.
- Cohort B3: Other R/R B-NHL.
- Measurable disease defined as ≥1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or ≥1 measurable extra-nodal lesion (long axis >1.0 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI) AND baseline fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion(s) compatible with CT- or MRI-defined anatomical tumor sites.
Laboratory parameters including the following:
- Lymphocyte count < 5 x 10^9/L
- Platelet count ≥ 75 x 10^9/L
- Absolute neutrophil count ≥ 1.0 x 10^9/L; growth factor support allowed in cases of documented bone marrow involvement
- Hemoglobin ≥ 9 g/dL, with or without transfusion
- Creatinine clearance ≥ 45 mL/min
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN), except patients with confirmed Gilbert's Syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN (unless attributed to hepatic involvement by lymphoma)
Exclusion Criteria:
- Primary CNS lymphoma or known CNS involvement by lymphoma at study screening
- Known past or current malignancy other than the inclusion diagnosis
- Known clinically significant cardiac disease
- Significant central nervous system disease
- Prior organ allograft
- Confirmed history or current autoimmune disorder or other disease requiring ongoing immune suppression
- Active Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or known Human Immunodeficiency Virus (HIV) infection
- Live virus vaccines within 28 days of the first dose of CLN-978, during treatment, and until the end of last dose of CLN-978
- Known active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including coronavirus disease of 2019 (COVID-19) infection, at the time of enrollment or within 7 days of the first dose of CLN-978.
Prior treatment with any of the following:
- Allogeneic HSCT
- Autologous HSCT within 30 days prior to the first dose of CLN-978
- Chimeric antigen receptor T cell therapy (CAR-T) within 30 days prior to the first dose of CLN-978
- Any investigational CD19 x CD3 T cell engager (TCE)
- Unconjugated CD19 monoclonal antibody ≤ 4 weeks prior to the first dose CLN-978
- Radio-conjugated or CD19 antibody-drug conjugate ≤ 12 weeks prior to the first dose CLN-978
- Investigational or standard of care monoclonal antibodies, chemotherapy, or other investigational agent ≤ 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of CLN-978
- Radiation therapy (XRT), with the exception of focal treatment for symptom control, ≤ 4 weeks of the first dose of CLN-978
- Woman of child-bearing potential who is pregnant, breast-feeding, or plans to become pregnant
- Male patients who plan to father a child or donate sperm within 120 days of last study drug administration
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A Dose Escalation
Patients with R/R B-NHL treated with CLN-978 in dose escalation cohorts
|
CD19xCD3 T cell engager
|
Experimental: Part B Dose Expansion
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.
|
CD19xCD3 T cell engager
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Define dose regimen for CLN-978
Time Frame: 24 months
|
Dose-limiting Toxicities (DLTs)
|
24 months
|
Safety and tolerability of CLN-978 based on AEs, AESIs, and SAEs
Time Frame: 24 months
|
Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs); incidence of dose interruptions and delays
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess preliminary efficacy of CLN-978 by overall response in patients with selective histologies of R/R B-NHL
Time Frame: 24 months
|
Overall response rate (ORR)
|
24 months
|
Assess preliminary efficacy of CLN-978 by complete response in patients with selective histologies of R/R B-NHL
Time Frame: 24 months
|
Complete response (CR)
|
24 months
|
Assess preliminary efficacy of CLN-978 by duration of response in patients with selective histologies of R/R B-NHL
Time Frame: 24 months
|
Duration of response (DOR)
|
24 months
|
Select PK parameters of CLN-978: AUC
Time Frame: 24 months
|
Area under-the-concentration-time curve of CLN-978
|
24 months
|
Select PK parameters of CLN-978: Cmax
Time Frame: 24 months
|
Maximum concentration of CLN-978
|
24 months
|
Select PK parameters of CLN-978: Half-life
Time Frame: 24 months
|
Half-life of CLN-978
|
24 months
|
Immunogenicity of CLN-978 and potential impact on drug exposure
Time Frame: 24 months
|
Incidence of anti-drug antibodies to CLN-978
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2023
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
May 5, 2023
First Submitted That Met QC Criteria
May 18, 2023
First Posted (Actual)
May 30, 2023
Study Record Updates
Last Update Posted (Estimated)
February 29, 2024
Last Update Submitted That Met QC Criteria
February 28, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLN-978-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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