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

NCT05879744 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CLN-978-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

NHL; NHL, Relapsed, Adult

Keywords

Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

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

  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

• Define dose regimen for CLN-978

  Dose-limiting Toxicities (DLTs)

  24 months

Secondary Outcomes (7)

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

  24 months

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

  24 months

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

  24 months

• Select PK parameters of CLN-978: AUC

  24 months

• Select PK parameters of CLN-978: Cmax

  24 months

Study Arms (2)

Part A Dose Escalation

EXPERIMENTAL

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

Drug: CLN-978

Part B Dose Expansion

EXPERIMENTAL

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.

Drug: CLN-978

Interventions

CLN-978 DRUG

CD19xCD3 T cell engager

Part A Dose Escalation; Part B Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• Primary CNS lymphoma or known CNS involvement by lymphoma at study screening
• 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

Sponsors & Collaborators

• Cullinan Therapeutics Inc.: lead

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Winship Cancer Institute at Emory University

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Recurrence; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 30, 2023
• Study Start: May 31, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

US (6)