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Monoclonal Antibodies
CPO107 for Non-Hodgkin's 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
Study Summary
This trial will test a new cancer treatment in people with advanced CD20-associated blood cancers who have no other options. The trial will see how well the treatment works and what side effects it has.
Eligible Conditions
- CD20 Positive Non-Hodgkin 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the recommended single-agent CPO107 RP2D
Secondary outcome measures
Efficacy assessment
Expression of anti-drug antibody (ADA)
Pharmacokinetic (PK)
+1 moreTrial 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.
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Who is running the clinical trial?
Conjupro Biotherapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
264 Total Patients Enrolled
Qingxi Wang, PhDStudy DirectorConjupro Biotherapeutics, Inc.
1 Previous Clinical Trials
Steven Novick, MD PhDStudy DirectorConjupro Biotherapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe infection or a serious medical condition that would make it difficult for you to receive the treatment in the study.Your disease has gotten worse or come back after trying at least two different types of treatment. One of those treatments must have included a medication that targets the CD20 protein.You have had severe allergic reactions to anti-CD20 treatment or any ingredients in the study drug.You have been diagnosed with follicular lymphoma or certain types of non-Hodgkin lymphoma and need treatment for your condition.You have had blood clotting problems or artery inflammation in the past 6 months.You have a disease that affects your brain or nervous system, and you must have completed radiation treatment to the brain at least 8 weeks before starting the study.If you have certain types of lymphoma that are not very aggressive, you will be excluded from the study unless there are no other treatment options for you.I'm sorry, but I need more information to accurately summarize the "others" criterion. Could you please provide more details or specific examples of the criteria you would like me to summarize?
Research Study Groups:
This trial has the following groups:- Group 1: PartA- Arm A
- Group 2: PartA- Arm B
- Group 3: Part B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there numerous medical centers administering this experiment in the US?
"This research is currently taking place in 5 different medical centres, with locations in Stanford and Denver being two of them. Moreover, participants should try to select the closest trial site available to reduce travel time."
Answered by AI
Has enrollment for this experiment already been initiated?
"Affirmative. Clinicaltrials.gov holds the evidence that this trial, initially posted on December 13th 2021, is actively seeking patients to enrol in it. The study requires 75 participants located across 5 medical sites."
Answered by AI
Could you provide an estimate of the aggregate number of participants in this clinical trial?
"Absolutely, the online information hosted on clinicaltrials.gov demonstrates that active recruitment is still in progress for this project, first issued December 13th 2021 and recently updated August 9th 2022. This medical research requires 75 individuals to be recruited from 5 different locations."
Answered by AI
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