CD20 Positive Non Hodgkin LymphomaPhase 1NCT04853329
Dose Escalation and Expansion Study of CPO107 for Patients With Advanced CD20-positive Non-Hodgkins Lymphoma
A Phase 1 study testing CPO107 in people with CD20 Positive Non Hodgkin Lymphoma, run by Conjupro Biotherapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CD20 Positive Non Hodgkin Lymphoma
- What is being tested?
- CPO107
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2021to 31 Jan 2023
- 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
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
NOTE: Trial was intended to be a Phase 1/2 trial, however the trial only enrolled patients in Study Part A (Phase 1) and was subsequently terminated early for business reasons.
- Conditions
- CD20 Positive Non Hodgkin Lymphoma
- Being tested
- CPO107
- Keywords
- CD20 positive, Non Hodgkin Lymphoma, CD20 CD47, CPO107, Phase 1
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPO107Drug
Also called JMT601
CD20-CD47 Bispecific Fusion Protein
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Drug: CPO107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Safety assessment-Incidence of treatment-emergent AEs (TEAEs)
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.
Measured: through study completion, an average of 1 year
Pharmacokinetic (PK)
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).
Measured: through study completion, an average of 1 year
Expression of anti-drug antibody (ADA)
The expression of anti-drug antibodies (ADAs) following administration will be assessed by analysis of serum samples.
Measured: through study completion, an average of 1 year
Efficacy assessment
To document any early indication of clinical efficacy.
Measured: through study completion, 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.
- First posted21 Apr 2021
- Study start13 Dec 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD20 Positive Non Hodgkin LymphomaStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conjupro Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Novick, MD PhD, Study director, Conjupro Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853329
- Sponsor's protocol ID
- CPO107-US-1001
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2021
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04853329
- Acronym / sponsor ID
- CPO107-US-1001
- Conditions
- CD20 Positive Non Hodgkin Lymphoma
- Keywords
- CD20 positive, Non Hodgkin Lymphoma, CD20 CD47, CPO107, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Conjupro Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
NOTE: Trial was intended to be a Phase 1/2 trial, however the trial only enrolled patients in Study Part A (Phase 1) and was subsequently terminated early for business reasons.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PartA- Arm A | Experimental | Drug: CPO107Arm 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). |
| PartA- Arm B | Experimental | Drug: CPO107Arm 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. |
| Part B | Experimental | Drug: CPO107Part 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPO107Also: JMT601CD20-CD47 Bispecific Fusion Protein | Drug | Part B, PartA- Arm A, PartA- Arm B |
Primary outcome
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.
4 secondary outcomes
Safety assessment-Incidence of treatment-emergent AEs (TEAEs)
Time frame: through study completion, an average of 1 year
Pharmacokinetic (PK)
Time frame: through study completion, an average of 1 year
Expression of anti-drug antibody (ADA)
Time frame: through study completion, an average of 1 year
Efficacy assessment
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Novick, MD PhD study director
Conjupro Biotherapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPO107 in people with CD20 Positive Non Hodgkin Lymphoma, run by Conjupro Biotherapeutics, Inc. at 1 site 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 13 inclusion and 16 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 9 Apr 2026. 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 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: Business reasons). 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 determine the recommended single-agent CPO107 RP2D (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2026.