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Monoclonal Antibodies
CHO-H01 for Lymphoma
Phase 1 & 2
Recruiting
Research Sponsored by Cho Pharma 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, approximately 16 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests CHO-H01, a new drug for non-Hodgkin's lymphoma, in patients whose cancer has returned or didn't respond to other treatments. The drug is given through an IV and targets cancer cells with a specific marker to destroy them.
Who is the study for?
This trial is for adults with a specific BMI range who have relapsed or refractory CD20+ non-Hodgkin's lymphoma. They should be relatively active (ECOG 0-2), have measurable cancer, and not received certain treatments recently. Participants need good heart function, agree to birth control if applicable, and expect to live more than 12 weeks.
What is being tested?
CHO-H01 is being tested in two parts: first to find the safest dose and then to see how well it works against the cancer. It's for those whose lymphoma has returned or didn't respond after treatment.
What are the potential side effects?
Potential side effects of CHO-H01 aren't detailed here but may include reactions related to immune system activation, infusion-related responses, and typical risks associated with new anticancer therapies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, approximately 16 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 16 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Best overall response
Number of subjects with adverse events (AE)
Number of subjects with dose-limiting toxicities
+1 moreSecondary study objectives
Clinical benefit rate
Duration of response
Duration of stable disease
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: CHO-H01+LenalidomideExperimental Treatment2 Interventions
Expansion phase with lenalidomide combination.
Phase2a:
Single cohort at Recommended Phase 2 Dose (RP2D) of CHO-H01.
Group II: CHO-H01Experimental Treatment1 Intervention
Dose escalation phase
Phase 1:
Five to six cohorts of escalating dose levels of CHO-H01 from 0.5mg/kg to 12 mg/kg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~2240
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies, chemotherapy, and targeted therapies. Monoclonal antibodies like rituximab target the CD20 protein on the surface of B-cells, leading to their destruction by the immune system.
This is crucial for NHL patients as it directly targets the malignant B-cells, potentially leading to remission. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects.
Targeted therapies, such as Bruton tyrosine kinase (BTK) inhibitors, interfere with specific molecules involved in cancer cell growth and survival. Understanding these mechanisms helps patients and doctors choose the most effective treatment with manageable side effects, improving outcomes and quality of life.
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Who is running the clinical trial?
Cho Pharma Inc.Lead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have a history of being allergic to eggs or any part of CHO-H01.You have had severe allergic reactions in the past to mouse proteins or previous treatments with CD20 monoclonal antibodies.Your body mass index (BMI) should be between 18 and 32 kg/m2.You have a history of seizures.You are expected to live for at least 3 months.You had a stem cell transplant within the past 100 days before starting CHO-H01 therapy.
Research Study Groups:
This trial has the following groups:- Group 1: CHO-H01+Lenalidomide
- Group 2: CHO-H01
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.