CHO-H01 for Lymphoma
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop any anti-CD20 treatments for at least 30 days before starting CHO-H01. If you are taking systemic corticosteroids, you must not exceed a daily dose of 15 mg prednisone or equivalent within 14 days before starting the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What data supports the effectiveness of the drug CHO-H01 for treating lymphoma?
Research on similar treatments, like the CD30-targeted drug brentuximab vedotin and PD-1 antibodies such as nivolumab, shows they are effective in treating Hodgkin lymphoma, especially in cases where the disease has returned or resisted other treatments. These drugs have shown promising results in improving cure rates and reducing long-term side effects.12345
What safety data exists for CHO-H01 (PD-1 inhibitors) in humans?
PD-1 inhibitors, used in treating relapsed or refractory classical Hodgkin lymphoma, have shown a generally favorable safety profile. Common side effects include mild to moderate immune-related reactions like fever, skin issues, and gastrointestinal problems, which were resolved in all patients. Serious side effects are rare, and no deaths were directly linked to the treatment.678910
How does the drug CHO-H01 differ from other treatments for lymphoma?
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Treatment
Dose escalation phase with CHO-H01 administered via IV infusion once weekly for 4 weeks in Cycle 1 and then once only on Day 1 in each subsequent 21-day cycle until disease progression or for up to 6 cycles
Phase 2a Treatment
Assessment of anticancer activity and safety of CHO-H01 plus lenalidomide in low-grade relapsed/refractory CD20+ non-Hodgkin's lymphoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- CHO-H01 (Monoclonal Antibodies)