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


Cullinan Therapeutics Inc.

Status and phase

Active, not recruiting
Phase 1


NHL, Relapsed, Adult


Drug: CLN-978

Study type


Funder types




Details and patient eligibility


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).


90 estimated patients




18+ years old


No Healthy Volunteers

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

Trial design

Primary purpose




Interventional model

Sequential Assignment


None (Open label)

90 participants in 2 patient groups

Part A Dose Escalation
Experimental group
Patients with R/R B-NHL treated with CLN-978 in dose escalation cohorts
Drug: CLN-978
Part B Dose Expansion
Experimental group
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

Trial contacts and locations



Central trial contact

Maria Akhondzadeh

Data sourced from

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