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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

Study 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 weeks3 visits

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]

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.

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is registration for this clinical experimentation open at the moment?

"Affirmative. Based on the information sourced from clinicaltrials.gov, this investigation is currently accepting volunteer patients. It was originally posted on January 15th 2020 and last updated July 10th 2023; requiring 11 participants to be recruited across 8 sites."

Answered by AI

How many places are in the purview of this experiment?

"At the present time, this medical trial is running at 8 sites across Taiwan. For those in New Taipei City, Kaohsiung and Taichung City, they are ideally situated to access one of these locations with minimal transportation needs."

Answered by AI

How many participants are being included in this clinical research?

"Affirmative, the information available at clinicaltrials.gov attests to this medical trial's ongoing recruitment efforts. The research was created on 15th January 2020 and last updated on 10th July 2023; 11 participants are needed from 8 sites in total."

Answered by AI

What results are expected from this research endeavor?

"The primary objective of this research, evaluated across 16 months from Screening to the last administration of CHO-H01 in Cycle 6, is to establish the occurrence of dose-limiting toxicities (Phase I). Secondary goals include quantifying Time to Cmax (tmax) and Area under the concentration-time curve over different time frames throughout Phase I & IIa. This data will be used to characterize the pharmacokinetics of CHO-H01."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess Safety and Efficacy of CHO-H01 in Subjects With Refractory or Relapsed Non-Hodgkin's Lymphoma

2020. "A Study to Assess Safety and Efficacy of CHO-H01 in Subjects With Refractory or Relapsed Non-Hodgkin's Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05950165.

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