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

Phase 1 & 2

Waitlist Available

Research Sponsored by Conjupro Biotherapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug for blood cancers with a specific marker called CD20. It targets patients who haven't responded to previous treatments. The drug works by binding to the CD20 marker on cancer cells, helping the immune system to destroy them. Rituximab, a monoclonal antibody targeting CD20, was the first therapeutic antibody for cancer treatment and has significantly improved outcomes for B-cell malignancies.

Eligible Conditions

Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the recommended single-agent CPO107 RP2D

Secondary study objectives

Efficacy assessment

Expression of anti-drug antibody (ADA)

Pharmacokinetic (PK)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: PartA- Arm BExperimental Treatment1 Intervention

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.

Group II: PartA- Arm AExperimental Treatment1 Intervention

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).

Group III: Part BExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out