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

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

NCT ID: NCT05879744

Condition: NHL
NHL, Relapsed, Adult

Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell

Conditions: Keywords:
Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: CLN-978
Description: CD19xCD3 T cell engager
Arm group label: Part A Dose Escalation
Arm group label: Part B Dose Expansion

Summary: 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).

Criteria for eligibility:
Criteria:
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: 1. Diffuse large B-cell lymphoma - de novo or transformed 2. High-grade B-cell lymphoma 3. Primary mediastinal large B-cell lymphoma 4. Follicular lymphoma 5. Mantle cell lymphoma 6. 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: 1. Cohort B1: R/R DLBCL that has relapsed after at least 2 prior therapies including a CD20 monoclonal antibody and anthracycline. 2. 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. 3. 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: 1. Lymphocyte count < 5 x 10^9/L 2. Platelet count ≥ 75 x 10^9/L 3. Absolute neutrophil count ≥ 1.0 x 10^9/L; growth factor support allowed in cases of documented bone marrow involvement 4. Hemoglobin ≥ 9 g/dL, with or without transfusion 5. Creatinine clearance ≥ 45 mL/min 6. Total bilirubin ≤ 1.5 × upper limit of normal (ULN), except patients with confirmed Gilbert's Syndrome 7. 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: 1. Allogeneic HSCT 2. Autologous HSCT within 30 days prior to the first dose of CLN-978 3. Chimeric antigen receptor T cell therapy (CAR-T) within 30 days prior to the first dose of CLN-978 4. Any investigational CD19 x CD3 T cell engager (TCE) 5. Unconjugated CD19 monoclonal antibody ≤ 4 weeks prior to the first dose CLN-978 6. Radio-conjugated or CD19 antibody-drug conjugate ≤ 12 weeks prior to the first dose CLN-978 7. 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 8. 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Alabama at Birmingham

Address:
City: Birmingham
Zip: 35294
Country: United States

Facility:
Name: City of Hope

Address:
City: Duarte
Zip: 91010
Country: United States

Facility:
Name: Winship Cancer Institute at Emory University

Address:
City: Atlanta
Zip: 30322
Country: United States

Facility:
Name: Massachusetts General Hospital

Address:
City: Boston
Zip: 02114
Country: United States

Facility:
Name: Hackensack University Medical Center

Address:
City: Hackensack
Zip: 07601
Country: United States

Facility:
Name: University of Texas Southwestern Medical Center

Address:
City: Dallas
Zip: 75390
Country: United States

Start date: May 31, 2023

Completion date: April 2027

Lead sponsor:
Agency: Cullinan Therapeutics Inc.
Agency class: Industry

Source: Cullinan Therapeutics Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05879744