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Dose Escalation and Expansion Study of CPO107 for Patients With Advanced CD20-positive Non-Hodgkins Lymphoma

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ClinicalTrials.gov Identifier: NCT04853329
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
Conjupro Biotherapeutics, Inc.

Brief Summary:
This first-in-human Phase 1 study will be a multicenter, dose-escalating, single-agent study conducted in patients with advanced CD20-associated hematological cancers for which the investigator determines there to be no other higher priority therapies available.

Condition or disease Intervention/treatment Phase
CD20 Positive Non Hodgkin Lymphoma Drug: CPO107 Phase 1 Phase 2

Detailed Description:

This first-in-human Phase 1 study will be a multicenter, dose-escalating, single-agent study conducted in patients with advanced CD20-associated hematological cancers for which the investigator determines there to be no other higher priority therapies available. All patients must have failed at least two prior lines of conventional systemic therapy that must also include an approved CD20 based treatment. All patients will need to have CD20-positive disease, as determined by the expression of CD20 on tumor cells assayed within 6 months prior to study entry.

The study will consist of 2 parts, Part A and Part B. In Part A of the study, dose escalation will proceed according to the guidelines in the Treatment and Dosing section below, following a rule-based design methodology. Two different schedules will be explored to establish the PK profile and thus better inform the selection of the final dosing schedule to be developed. Arm A will explore a continuous weekly dosing schedule and will commence first. Arm B will explore a 3 weekly schedule in which a single dose is administered every 3 weeks. Part B dose expansion of the study will commence, in which a single dosing schedule will be explored in CD20-positive patients. The schedule will be selected based on PK and safety determinants from Study Part A.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2, Multicenter, First-In-Human, Dose Escalation and Dose Expansion Study of CPO107 Administered Intravenously to Patients With Advanced CD20-positive Non-Hodgkins Lymphoma
Actual Study Start Date : December 13, 2021
Estimated Primary Completion Date : December 15, 2024
Estimated Study Completion Date : December 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: PartA- Arm A

Arm A 1-6 subjects will be enrolled at dose levels of CPO107 at (1, 3, 6, 12, 20 mg/kg).

Each subject group will receive multiple cycles of a weekly dose of CPO-107 (1 cycle=21 days=3 treatments).

Drug: CPO107
CD20-CD47 Bispecific Fusion Protein
Other Name: JMT601

Experimental: PartA- Arm B
Arm B will explore a 3 weekly schedule in which a single dose is administered every 3 weeks (1 cycle=21 days=1 treatment). The starting dose for Arm B will be the dose level below the Arm A level that provides an equivalent dose over a 3-week period.
Drug: CPO107
CD20-CD47 Bispecific Fusion Protein
Other Name: JMT601

Experimental: Part B
Part B with either: second or greater relapse OR refractory patients, as defined by not achieving a CR after 2 cycles of a standard first line chemoimmunotherapy regimen or not achieving a CR following 1 cycle of a second line chemotherapy regimen.
Drug: CPO107
CD20-CD47 Bispecific Fusion Protein
Other Name: JMT601




Primary Outcome Measures :
  1. To determine the recommended single-agent CPO107 RP2D [ Time Frame: through study completion, an average of 1 year ]
    To determine the recommended single-agent CPO107 RP2D and schedule for further exploration in CD20 positive Non-Hodgkins Lymphoma.


Secondary Outcome Measures :
  1. Safety assessment-Incidence of treatment-emergent AEs (TEAEs) [ Time Frame: through study completion, an average of 1 year ]
    Safety will be assessed through the analysis of the reported incidence of treatment-emergent AEs (TEAEs) by evaluating adverse events based on laboratory results, vital signs and ECG findings.

  2. Pharmacokinetic (PK) [ Time Frame: through study completion, an average of 1 year ]
    The pharmacokinetic of CPO-107 will be assessed by measuring the blood concentration of the drug in the plasma at various timepoints and calculation of parameters, such as Peak Plasma Concentration (Cmax).

  3. Expression of anti-drug antibody (ADA) [ Time Frame: through study completion, an average of 1 year ]
    The expression of anti-drug antibodies (ADAs) following administration will be assessed by analysis of serum samples.

  4. Efficacy assessment [ Time Frame: through study completion, an average of 1 year ]
    To document any early indication of clinical efficacy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The following key inclusion criteria apply to both Part A and Part B:

  • Diagnosis of CD20 positive NHL. CD20 assay to have been performed within 6 months prior to protocol entry. Eligible NHL subtypes include Diffuse Large B-Cell Lymphoma (DLBCL, not otherwise specified, NOS), Follicular Lymphoma, Chronic lymphocytic leukemia/small lymphocytic lymphoma, B cell prolymphocytic leukemia and Mantle cell lymphoma.
  • Patients with SLL must have received, or not be eligible for, BTK and BCL-2 inhibitor therapy.
  • Disease progression or relapse following at least two prior lines of conventional systemic therapy for advanced disease. Dosing regimen must have included a CD20 targeted therapy (for example, RCHOP).
  • A clinical indication for treatment must be present for patients with Follicular Lymphoma and Chronic/Small/Prolymphocytic/Mantle B-cell non-Hodgkin lymphoma.
  • Having at least one measurable target lesion present and documented by RECIST 1.1.
  • Adequate organ function, such as Renal function, Hepatic Function, Cardiovascular, Adequate hematological reserve.
  • Complete resolution of all prior toxicities from prior anticancer therapy, defined as having resolved to baseline or to common terminology criteria for adverse events (CTCAE) grade≤1, with the exception of alopecia, or to the levels dictated in the inclusion/exclusion criteria, and a washout period of 5 half-lives of prior small molecule systemic therapy.
  • Life expectancy >12 weeks.
  • Age: Lower age limit of 18 years.
  • ECOG performance status 0 or 1 at screening.
  • Ability to understand the nature of this study, comply with protocol requirements, and give written informed consent. For minors, legal guardian willingness to give written informed consent with patient assent, where appropriate.
  • Patients of reproductive potential: All female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before study entry.

Exclusion Criteria:

The following key exclusion criteria apply:

  • Patients with indolent Follicular Lymphoma or Chronic/Small/Prolymphocytic/Mantle B-cell non-Hodgkin lymphoma in need of immediate cytoreductive therapy are excluded, unless the patient has no remaining treatment choice with potential benefit.
  • Patient has participated in any investigational research study and is being screened for participation within a period of 5 half-lives, or 4 weeks of the last dose of the investigational therapy, whichever is longer.
  • Patients with history of severe hypersensitivity reactions to anti-CD20 treatment or any components of study drug formulation.
  • Presence or recent history within 6 months of arteritis or any systemic clotting disorder, thrombotic or thromboembolic events.
  • History or presence of autoimmune conditions; patients who have a medical condition that requires chronic systemic steroid therapy or requires any other form of immunosuppressive medication.
  • Patients with a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE grade 1) using Fredericia's QT correction formula.
  • Active or latent hepatitis B or active hepatitis C or any uncontrolled infection at screening; HIV positive test within 8 weeks of screening.
  • Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  • Presence of other active cancers, or history of treatment for invasive cancer ≤3 years.
  • Patients who started erythropoietin or granulocyte colony-stimulating factor (G-CSF), pegfilgrastim, or filgrastim ≤4 weeks prior to the first dose of the study drug.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • Active CNS disease involvement; CNS directed radiation must be completed >8 weeks prior to CPO107 infusion.
  • Non-CNS site of radiation must be completed >2 weeks prior to CPO107 infusion.
  • Pregnant or nursing (lactating) women
  • And others

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853329


Contacts
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Contact: Kevin Romanko 609-686-6502 clinicaltrials.gov@cspcus.com
Contact: Audrey Li 609-356-0210 clinicaltrials.gov@cspcus.com

Locations
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United States, California
University of Southern California - Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Christine Duran    323-865-0371    duran_c@med.usc.edu   
Principal Investigator: Zaw Win Myint, MD         
Stanford University - Saul A Rosenberg Prof of Lymphoma Stanford Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Lisa Jerden, BA    650-721-4096    ljerden@stanford.edu   
Contact: Mariel Rojas, MS    650-723-0530    mlrojas@stanford.edu   
Principal Investigator: Ranjana Advani, MD         
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Luke Mountjoy, DO    720-754-4800      
United States, North Carolina
Novant Health - Charlotte Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Alan Skarbnik, MD    980-302-6600    azskarbnik@novanthealth.org   
Novant Health - Winston-Salem Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Alan Skarbnik, MD    980-302-6600    azskarbnik@novanthealth.org   
Sponsors and Collaborators
Conjupro Biotherapeutics, Inc.
Investigators
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Study Director: Steven Novick, MD PhD Conjupro Biotherapeutics, Inc.
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Responsible Party: Conjupro Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04853329    
Other Study ID Numbers: CPO107-US-1001
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Conjupro Biotherapeutics, Inc.:
CD20 positive
Non Hodgkin Lymphoma
CD20 CD47
CPO107
Phase 1/2
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases