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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
Are there results?
None posted in the registry

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
Show all 22Show fewer
  • 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

Other trials in United States

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).

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 groups in NCT05879744
Study groupRoleWhat they receive
Part A Dose EscalationExperimentalPatients with R/R B-NHL treated with CLN-978 in dose escalation cohorts
Receives: Drug: CLN-978
Part B Dose ExpansionExperimentalPatients 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.

  1. 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

  2. Define dose regimen for CLN-978

    Dose-limiting Toxicities (DLTs)

    Measured: 24 months

Secondary outcomes (7)

  1. 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

  2. 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

  3. 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

  4. Select PK parameters of CLN-978: AUC

    Area under-the-concentration-time curve of CLN-978

    Measured: 24 months

  5. Select PK parameters of CLN-978: Cmax

    Maximum concentration of CLN-978

    Measured: 24 months

  6. Select PK parameters of CLN-978: Half-life

    Half-life of CLN-978

    Measured: 24 months

  7. 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.

  1. First posted30 May 2023
  2. Study start31 May 2023
  3. Primary completion1 Jun 2024
  4. Study completion1 Jun 2024

Why it stopped: Strategic business decision

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic business decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of CLN-978 based on AEs, AESIs, and SAEs (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05879744.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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