What side effects are associated with this type of intervention?

Common side effects of monoclonal antibodies targeting CD20, such as rituximab, ofatumumab, and obinutuzumab, used in the treatment of Non-Hodgkin's Lymphoma include infusion reactions, which can be severe, especially during the first cycle. These reactions may present as fever, chills, rash, and hypotension. Other side effects include increased risk of infections, neutropenia, and thrombocytopenia. Additionally, patients may experience fatigue, nausea, and headache. Adjustments in administration schedules are often made to mitigate these side effects, particularly in patients with high white blood cell counts.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies targeting CD20 for the treatment of Non-Hodgkin's Lymphoma (NHL). Rituximab was the first anti-CD20 monoclonal antibody approved and has been widely used in combination with chemotherapy for various types of NHL. Ofatumumab and obinutuzumab are other FDA-approved anti-CD20 monoclonal antibodies, used particularly in relapsed or refractory cases of NHL. These treatments have significantly improved outcomes for patients with NHL by targeting the CD20 antigen on B-cells.

What other types of research exist?

Promising alternatives to CHO-H01 for Non-Hodgkin's Lymphoma patients include: 1) Rituximab, a well-established monoclonal antibody targeting CD20, often used in combination with chemotherapy. 2) Obinutuzumab, another anti-CD20 monoclonal antibody, which has shown efficacy in combination with chemotherapy. 3) CAR T-cell therapies, such as axicabtagene ciloleucel and tisagenlecleucel, which have demonstrated significant efficacy in relapsed or refractory NHL. 4) Bispecific T-cell engagers (BiTEs), like blinatumomab, which engage T-cells to target and kill lymphoma cells. 5) Novel BTK inhibitors, such as acalabrutinib and zanubrutinib, which have shown promise in treating various subtypes of NHL.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 16 months for reporting.

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 more

Secondary study objectives

Clinical benefit rate

Duration of response

Duration of stable disease

+5 more

Awards & 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

Do I qualify?Apply below to find out

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.