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

Status
Active
Cancer Type
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05879744
Protocol IDs
CLN-978-001 (primary)
NCI-2023-04426
Study Sponsor
Cullinan Oncology Inc.

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).

Eligibility

  1. Eastern Cooperative Oncology Group (ECOG) PS = 2
  2. Documented diagnosis of one of the below CD19+ B-cell neoplasms according to WHO classification (Swerdlow et al., 2016) or WHO classification 2008:
  3. Diffuse large B-cell lymphoma - de novo or transformed
  4. High-grade B-cell lymphoma
  5. Primary mediastinal large B-cell lymphoma
  6. Follicular lymphoma
  7. Mantle cell lymphoma
  8. Marginal zone lymphoma (nodal, extranodal, or mucosa-associated)
  9. Relapsed, progressive, and/or refractory disease after at least 2 lines of therapy.
  10. For Part B expansion cohorts:
  11. Cohort B1: R/R DLBCL that has relapsed after at least 2 prior therapies including a CD20 monoclonal antibody and anthracycline.
  12. 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.
  13. Cohort B3: Other R/R B-NHL.
  14. 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.
  15. Laboratory parameters including the following:
  16. Lymphocyte count < 5 x 10^9/L
  17. Platelet count = 75 x 10^9/L
  18. Absolute neutrophil count = 1.0 x 10^9/L; growth factor support allowed in cases of documented bone marrow involvement
  19. Hemoglobin = 9 g/dL, with or without transfusion
  20. Creatinine clearance = 45 mL/min
  21. Total bilirubin = 1.5 × upper limit of normal (ULN), except patients with confirmed Gilbert's Syndrome
  22. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3.0 × ULN (unless attributed to hepatic involvement by lymphoma)

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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