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Relapsed Lymphoid MalignanciesPhase 1/2NCT04880564

A Study of CN1 in Combination With CN401 in Adult Patients With Relapsed/Refractory Lymphoid Malignancies

A Phase 1/2 study testing CN1, 0.5mg/kg and CN401, 400mg, CN1, 1mg/kg and CN401, 600mg and CN1, 1mg/kg and CN401, 800mg in people with Relapsed Lymphoid Malignancies and Refractory Lymphoid Malignancies, run by Curon Biopharmaceutical (Australia) Co Pty Ltd at 1 site in Australia.

Terminated

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

Official record
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Trial summary

The study is designed to investigate the safety, tolerability and preliminary efficacy in combination with CN1 and CN401 in adult patients with relapsed/refractory lymphoid malignancies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CN1, 0.5mg/kg and CN401, 400mg, CN1, 1mg/kg and CN401, 600mg and CN1, 1mg/kg and CN401, 800mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteAustralia
Study dates
28 Jul 2021to 30 Sep 2022
Phase
Phase 1/2
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

  • Age ≥ 18 years on the day of signing informed consent.
  • Based on pathology review at the local institution, using the most recent edition of the World Health Organization (WHO) Classification of Tumors of Hematopoietic and Lymphoid Tissues as guidance, leading to the diagnosis of one of the following diseases and their histological subtypes: PTCL, CTCL, and B-cell NHL.
  • Patients must have relapsed or refractory disease after at least one prior systemic anti-tumor treatment.
  • The patients enrolled in Phase II of the study should have received NOT more than five lines of prior systemic therapies.
  • Patients must have at least one evaluable lesion per Lugano 2014 Criteria. Measurable lesions are defined as those that can be accurately measured in at least two dimensions with conventional techniques (positron emission tomography/Computed tomography [PET/CT], magnetic resonance imaging [MRI]) or as > 1.5 cm with spiral CT scan. Patients with non-measurable lesions but assessable diseases (e.g., marrow disease without other radiographically measurable diseases) may be enrolled on a case-by-case basis in discussion with the Sponsor.
  • ECOG performance status 0 to 2.
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  • At least 3 months of expected survival.
  • Adequate organ functions, further defined as:
  • Hemoglobin ≥ 9 g/dL.
  • Absolute neutrophil count (ANC) ≥ 1 × 10E+09/L.
  • Platelets ≥ 50 × 10E+09/L (patient without bone marrow [BM] involvement) and ≥ 30 × 10E+09/L (patient with BM involvement).
  • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN if known liver involvement. The ALT and AST should be ≤ 1.5 × ULN in absence of liver involvement/metastasis.
  • Serum creatinine ≤ 2.0 mg/dL or calculated creatinine clearance ≥ 50 mL/min (as calculated by the Cockcroft-Gault method).
  • Activated partial thromboplastin time (APTT) or international normalized ratio (INR) ≤ 1.5 × ULN (unless patient is receiving anticoagulants).

Who cannot join

  • Received any anti-tumour treatment (i.e., chemotherapy, radiotherapy, immunotherapy, biologic therapy, endocrine therapy, etc.,) within four weeks (or five half-lives of the agent, whichever is shorter) prior to the first dose of study drugs, with the following exceptions:
  • Palliative radiation therapy within 2 weeks.
  • Oral small molecule targeted therapies within 2 weeks prior to the first dose of study drugs or within 5 half-lives of the drug, whichever is shorter.
  • Herbal medications within 7 days prior to the first dose.
  • Received other investigational agents (not yet approved by any regulatory agency) within four weeks prior to the first dose of any study drugs.
  • Immunosuppressive medication > 10 mg prednisolone per day or equivalent within 14 days prior to the first dose of the study drug. Note: Use of immunosuppressive medications as prophylaxis in subjects with contrast allergies are acceptable. In addition, temporary uses of corticosteroids considered non-clinically significant may be approved on a case-by-case basis in discussion with the Sponsor.
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  • Known clinically active central nervous system (CNS) or meningeal involvement. In the absence of symptoms, investigation into CNS involvement is not required. Patients are eligible if metastases have been treated, patients are neurologically returned to baseline or neurologically stable for at least four weeks and not requiring steroid therapy for at least one week prior to Cycle 1 Day 1.
  • Active infection and in current need of, or likely to need, intravenous (IV) anti-infective therapy.
  • History of immunodeficiency, including history of any positive test result for human immunodeficiency virus (HIV) antibody.
  • Patients who are known to be hepatitis B or C positive (positive HBsAg and/or detectable level of HBV DNA or positive HCV antibody).
  • Active Epstein Barr virus (EBV) unrelated to underlying lymphoma (positive serology for anti-EBV VCA IgM antibody and negative for anti-EBV EBNA IgG antibody, or clinical manifestations and positive EBV polymerase chain reaction [PCR] consistent with active EBV infection).
  • Active CMV (positive serology for anti-CMV IgM antibody, negative for anti-CMV IgG antibody, and positive CMV PCR with clinical manifestations consistent with active CMV infection) and requiring therapy.
  • Current history of a serious uncontrolled medical disorder, metabolic dysfunction, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or render the patient at high risk from treatment complications.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Monash Health - Monash Medical Centre

    Bentleigh, Victoria, 3168

Other trials in Australia

About this study

Official title: An Open-label, Multi-centre, Phase I/II Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of CN1 in Combination With CN401 in Adult Patients With Relapsed/Refractory Lymphoid Malignancies

The study is designed to investigate the safety, tolerability and preliminary efficacy in combination with CN1 and CN401 in adult patients with relapsed/refractory lymphoid malignancies.

Read the detailed description

This is an open-label, multi-center, phase I/II study. The study includes two study drugs CN1 and CN401 and will be conducted in two parts: phase 1 and phase 2.

Phase I: Dose-finding study for the assessment of dose limiting toxicities (DLTs) at 3 or more dose levels in patients with advanced lymphoid malignancies.

Phase II: Expansion study to evaluate the preliminary efficacy of CN1 in combination with CN401 at the RP2D in parallel patient cohorts grouped by non-Hodgkin's Lymphoma (NHL) subtype.

There will 9-18 patients enrolled in the Phase 1 portion of the study and 15- 60 patients will be enrolled in Phase 2 - dosing determined by Phase 1.

Being tested
CN1, 0.5mg/kg and CN401, 400mg, CN1, 1mg/kg and CN401, 600mg, CN1, 1mg/kg and CN401, 800mg, CN1, 3mg/kg and CN401, 800mg, CN1, 10mg/kg and CN401, 800mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CN1, 0.5mg/kg and CN401, 400mgDrug

    CN1(0.5mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(400mg) will be administered orally twice daily.

  • CN1, 1mg/kg and CN401, 600mgDrug

    CN1(1mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(600mg) will be administered orally twice daily.

  • CN1, 1mg/kg and CN401, 800mgDrug

    CN1(1mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(800mg) will be administered orally twice daily.

  • CN1, 3mg/kg and CN401, 800mgDrug

    CN1(3mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(800mg) will be administered orally twice daily.

  • CN1, 10mg/kg and CN401, 800mgDrug

    CN1(10mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(800mg) will be administered orally twice daily.

Study groups in NCT04880564
Study groupRoleWhat they receive
A (CN1 0.5mg/kg and CN401 400mg)ExperimentalPatients were administered with CN1, 0.5mg/kg, once every three week in combination with 400mg CN401 twice a day, fasted. Dosage/Route of admin: CN1- Intravenous Infusion(IV); CN401- Tablet, Oral Three to six patients are expected to be enrolled in each arm.
Receives: Drug: CN1, 0.5mg/kg and CN401, 400mg
B (CN1 1mg/kg and CN401 600mg)ExperimentalPatients were administered with CN1, 1mg/kg, once every three week in combination with 600mg CN401 twice a day, fasted. Dosage/Route of admin: CN1- Intravenous Infusion(IV); CN401- Tablet, Oral Three to six patients are expected to be enrolled in each arm
Receives: Drug: CN1, 1mg/kg and CN401, 600mg
C (CN1 1mg/kg and CN401 800mg)ExperimentalPatients were administered with CN1, 1mg/kg, once every three week in combination with 800mg CN401 twice a day, fasted. Dosage/Route of admin: CN1- Intravenous Infusion(IV); CN401- Tablet, Oral Three to six patients are expected to be enrolled in each arm
Receives: Drug: CN1, 1mg/kg and CN401, 800mg
D (CN1 3mg/kg and CN401 800mg)ExperimentalPatients were administered with CN1, 3mg/kg, once every three week in combination with 800mg CN401 twice a day, fasted. Dosage/Route of admin: CN1- Intravenous Infusion(IV); CN401- Tablet, Oral Three to six patients are expected to be enrolled in each arm
Receives: Drug: CN1, 3mg/kg and CN401, 800mg
E (CN1 10mg/kg and CN401 800mg)ExperimentalPatients were administered with CN1, 10mg/kg, once every three week in combination with 800mg CN401 twice a day, fasted. Dosage/Route of admin: CN1- Intravenous Infusion(IV); CN401- Tablet, Oral Three to six patients are expected to be enrolled in each arm
Receives: Drug: CN1, 10mg/kg and CN401, 800mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the safety and tolerability of CN1 in combination with CN401 in patients with relapsed/refractory lymphoid malignancies through Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: Measurements at Baseline till completion of last safety visit (270 days)

  2. To determine maximum tolerated dose and/or Recommended Phase II Dose (RP2D) of CN1 in combination with CN401

    Measured by Incidence of dose limiting toxicities (DLT) during the first cycle of treatment with CN1 in combination with CN401.

    Measured: DLT assessed within 21 days after the first dose

  3. To assess the change in anti-tumor activity of CN1 in combination with CN401 through Objective Response Rate analysis

    Measured/determined by Objective Response Rate

    Measured: Baseline to End of the Treatment assessed up to an average of 1 year

Secondary outcomes (13)

  1. To further evaluate the safety and tolerability of CN1 in combination with CN401 in patients with relapsed/refractory lymphoid malignancies through Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: Measurements at Baseline till completion of last safety visit (270 days)

  2. To evaluate safety and tolerability of CN1 and CN401 in patients with relapsed/refractory lymphoid malignancies through vital signs as assessed by heart rate

    Measured by vital sign as assessed by heart rate

    Measured: Baseline to End of the Treatment assessed up to an average of 1 year

  3. To evaluate safety and tolerability of CN1 and CN401 in patients with relapsed/refractory lymphoid malignancies through vital signs as assessed by respiratory rate

    Measured by vital sign as assessed by respiratory rate

    Measured: Baseline to End of the Treatment assessed up to an average of 1 year

  4. To evaluate safety and tolerability of CN1 and CN401 in patients with relapsed/refractory lymphoid malignancies through vital signs as assessed by body temperature

    Measured by vital sign as assessed by body temperature

    Measured: Baseline to End of the Treatment assessed up to an average of 1 year

  5. To evaluate safety and tolerability of CN1 and CN401 in patients with relapsed/refractory lymphoid malignancies through vital signs as assessed by pulse, systolic blood pressure, and diastolic blood pressure

    Measured by vital sign as assessed by pulse, systolic blood pressure, and diastolic blood pressure

    Measured: Baseline to End of the Treatment assessed up to an average of 1 year

  6. To characterize the pharmacokinetics of CN1 and CN401 when administered in combination through Area under the under the drug concentration-time curve.

    The following parameter is used for evaluation during PK assessments: Area under the drug concentration-time curve (AUC(0-last), AUC0-inf, AUCtau)

    Measured: Baseline to End of the Treatment assessed up to an average of 1 year

  7. To characterize the pharmacokinetics of CN1 and CN401 when administered in combination through Cmax and Tmax.

    The following parameter is used for evaluation during PK assessments: Maximum concentration (Cmax) and Time to maximum concentration (Tmax)

    Measured: Baseline to End of the Treatment assessed up to an average of 1 year

  8. To characterize the pharmacokinetics of CN1 and CN401 when administered in combination through Apparent terminal half-life (t½).

    The following parameter is used for evaluation during PK assessments: Apparent terminal half-life (t½)

    Measured: Baseline to End of the Treatment assessed up to an average of 1 year

  9. To characterize the pharmacokinetics of CN1 and CN401 when administered in combination through Apparent terminal elimination rate constant (Kel).

    The following parameter is used for evaluation during PK assessments: Apparent terminal elimination rate constant (Kel)

    Measured: Baseline to End of the Treatment assessed up to an average of 1 year

  10. To characterize the pharmacokinetics of CN1 and CN401 when administered in combination through Apparent clearance.

    The following parameter is used for evaluation during PK assessments: Apparent clearance (CL/F and CL/Fss)

    Measured: Baseline to End of the Treatment assessed up to an average of 1 year

  11. To characterize the pharmacokinetics of CN1 and CN401 when administered in combination through Accumulation ration.

    The following parameter is used for evaluation during PK assessments: Accumulation ration (RA)

    Measured: Baseline to End of the Treatment assessed up to an average of 1 year

  12. To characterize the pharmacokinetics of CN1 and CN401 when administered in combination through Apparent terminal volume of distribution.

    The following parameter is used for evaluation during PK assessments: Apparent clearance (Vz/F and Vz/Fss)

    Measured: Baseline to End of the Treatment assessed up to an average of 1 year

  13. To further assess change in anti-tumor activity of CN1 in combination with CN401 through ORR

    Measured/determined by Objective Response Rate

    Measured: Baseline to End of the treatment visit assessed up to an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2021
  2. Study start28 Jul 2021
  3. Primary completion29 Aug 2022
  4. Study completion30 Sep 2022

Why it stopped: Sponsor decided that there was no benefit in the drug treatment and due to company change in landscape in the new year.

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04880564
Sponsor's protocol ID
CN1-201
Status last verified
Oct 2022
First submitted
14 Apr 2021
Last updated
24 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CN1, 0.5mg/kg and CN401, 400mg, CN1, 1mg/kg and CN401, 600mg and CN1, 1mg/kg and CN401, 800mg in people with Relapsed Lymphoid Malignancies and Refractory Lymphoid Malignancies, run by Curon Biopharmaceutical (Australia) Co Pty Ltd at 1 site in Australia.

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 15 inclusion and 13 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 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: Sponsor decided that there was no benefit in the drug treatment and due to company change in landscape in the new year.). 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?

To evaluate the safety and tolerability of CN1 in combination with CN401 in patients with relapsed/refractory lymphoid malignancies through Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0 (time frame: Measurements at Baseline till completion of last safety visit (270 days)). The study lists 3 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 NCT04880564.

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 24 Oct 2022.

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