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

NCT04853329 | Terminated Phase 1 FDA Drug

• 1 other identifier: CPO107-US-1001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

CD20 Positive Non Hodgkin Lymphoma

Keywords

CD20 positive; Non Hodgkin Lymphoma; CD20 CD47; CPO107; Phase 1

Outcome Measures

Primary Outcomes (1)

• To determine the recommended single-agent CPO107 RP2D

  To determine the recommended single-agent CPO107 RP2D and schedule for further exploration in CD20 positive Non-Hodgkins Lymphoma.

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Safety assessment-Incidence of treatment-emergent AEs (TEAEs)

  through study completion, an average of 1 year

• Pharmacokinetic (PK)

  through study completion, an average of 1 year

• Expression of anti-drug antibody (ADA)

  through study completion, an average of 1 year

• Efficacy assessment

  through study completion, an average of 1 year

Study Arms (3)

PartA- Arm A

EXPERIMENTAL

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

PartA- Arm B

EXPERIMENTAL

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

Part B

EXPERIMENTAL

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

Interventions

CPO107 DRUG

CD20-CD47 Bispecific Fusion Protein

Also known as: JMT601

Part B; PartA- Arm A; PartA- Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Conjupro Biotherapeutics, Inc.: lead

Study Sites (1)

Novant Health

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Steven Novick, MD PhD

  Conjupro Biotherapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: April 21, 2021
• Study Start: December 13, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)