NHLPhase 1NCT05879744
A Study of CLN-978 in Patients With Relapsed or Refractory (R/R) B Cell Non-Hodgkin Lymphoma (B-NHL)
A Phase 1 study testing CLN-978 in people with NHL and NHL, Relapsed, Adult, run by Cullinan Therapeutics Inc. at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NHL, NHL, Relapsed, Adult
- What is being tested?
- CLN-978
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 May 2023to 1 Jun 2024
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Winship Cancer Institute at Emory University
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
City of Hope
Duarte, California, 91010
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: 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).
- Conditions
- NHL, NHL, Relapsed, Adult
- Being tested
- CLN-978
- Keywords
- Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Recurrence, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLN-978Drug
CD19xCD3 T cell engager
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Escalation | Experimental | Patients with R/R B-NHL treated with CLN-978 in dose escalation cohorts Receives: 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. Receives: Drug: CLN-978 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Define dose regimen for CLN-978
Dose-limiting Toxicities (DLTs)
Measured: 24 months
Secondary outcomes (7)
Assess preliminary efficacy of CLN-978 by overall response in patients with selective histologies of R/R B-NHL
Overall response rate (ORR)
Measured: 24 months
Assess preliminary efficacy of CLN-978 by complete response in patients with selective histologies of R/R B-NHL
Complete response (CR)
Measured: 24 months
Assess preliminary efficacy of CLN-978 by duration of response in patients with selective histologies of R/R B-NHL
Duration of response (DOR)
Measured: 24 months
Select PK parameters of CLN-978: AUC
Area under-the-concentration-time curve of CLN-978
Measured: 24 months
Select PK parameters of CLN-978: Cmax
Maximum concentration of CLN-978
Measured: 24 months
Select PK parameters of CLN-978: Half-life
Half-life of CLN-978
Measured: 24 months
Immunogenicity of CLN-978 and potential impact on drug exposure
Incidence of anti-drug antibodies to CLN-978
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start31 May 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Why it stopped: Strategic business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NHLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cullinan Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879744
- Sponsor's protocol ID
- CLN-978-001
- Status last verified
- Mar 2025
- First submitted
- 5 May 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No