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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 from cycle 1 day 1 (cycle 1 is of 28 days) up to final follow-up visit (30 days after the last administration of cho-h01 in cycle 6) [approximately 16 months]
Awards & highlights

Summary

This trial will assess the safety and effectiveness of a drug for non-Hodgkin's lymphoma. Part 1 will test safety and dose, Part 2 will test effectiveness.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~from screening (day -28 to day 1) up to final follow-up visit (30 days after the last administration of cho-h01 in cycle 6) [approximately 16 months]
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (day -28 to day 1) up to final follow-up visit (30 days after the last administration of cho-h01 in cycle 6) [approximately 16 months] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best overall response (Phase IIa)
Number of subjects with adverse events (AE) (Phase I and Phase IIa)
Number of subjects with dose-limiting toxicities (Phase I)
+1 more
Secondary outcome measures
Accumulation ratio for AUC(0-tau) (Phase I and Phase IIa)
Accumulation ratio for Cmax (Phase I and Phase IIa)
Area under the concentration-time curve from zero extrapolated to infinity [AUC(0-inf)] (Phase I and Phase IIa)
+20 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CHO-H01Experimental Treatment1 Intervention
Subjects will receive CHO-H01.

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.

Find a Location

Who is running the clinical trial?

Cho Pharma Inc.Lead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled

Media Library

CHO-H01 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05950165 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: CHO-H01
Non-Hodgkin's Lymphoma Clinical Trial 2023: CHO-H01 Highlights & Side Effects. Trial Name: NCT05950165 — Phase 1 & 2
CHO-H01 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05950165 — Phase 1 & 2
~2 spots leftby Jul 2025