CHO-H01 for Lymphoma

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Cho Pharma Inc.

Must not be taking: PD-L1, PD-1, CTLA-4, Corticosteroids

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

How does the drug CHO-H01 differ from other treatments for lymphoma?

CHO-H01 is unique because it may involve targeting the PD-1/PD-L1 pathway, which is a mechanism used by some immune checkpoint inhibitors to treat relapsed or refractory classic Hodgkin's lymphoma by enhancing the body's immune response against cancer cells. ^{1 11 12 13 14}

Research Team

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

Your body mass index (BMI) should be between 18 and 32 kg/m2.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Phase I: Have histologically confirmed CD20 + non-Hodgkin's lymphoma according to the World Health Organization's 2016 classification: Low grade lymphoma: follicular lymphoma (Grades 1-3a), marginal zone lymphoma, small lymphocytic lymphoma; Other lymphoma: DLBCL (NOS: to include germinal center B-cell-like [GCB] and activated B-cell-like [ABC]), follicular lymphoma Grade 3b, mantel cell lymphoma; primary mediastinal large B-cell lymphoma.

Exclusion Criteria

Must not have any known or current illnesses (such as autoimmune disease, unless well controlled or resolved), infection, or other condition that could limit study compliance or interfere with assessments

Subjects with known hepatitis B surface antigen (HBsAg) seropositive or known or suspected active hepatitis C infection with detectable viral load

Subjects who have received (or are receiving) systemic corticosteroids: At a daily dose higher than 15 mg prednisone or equivalent within 14 days prior to the first administration of CHO-H01; Topical, inhaled, nasal, and ophthalmic steroids are allowed

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

19 weeks

Phase 2a Treatment

Assessment of anticancer activity and safety of CHO-H01 plus lenalidomide in low-grade relapsed/refractory CD20+ non-Hodgkin's lymphoma

16 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CHO-H01 (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: CHO-H01+Lenalidomide Experimental Treatment 2 Interventions

Expansion phase with lenalidomide combination. Phase2a: Single cohort at Recommended Phase 2 Dose (RP2D) of CHO-H01.

Group II: CHO-H01 Experimental Treatment 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Who Is Running the Clinical Trial?

Cho Pharma Inc.

Lead Sponsor

Trials

2

Patients Recruited

60+

Findings from Research

In a study of 35 patients with relapse/refractory classical Hodgkin's lymphoma, PD-1 inhibitors showed an overall response rate of 80%, with a complete response rate of 62.9%, indicating strong efficacy both as monotherapy and in combination with chemotherapy.

Patients receiving PD-1 inhibitors combined with chemotherapy had higher response rates (94.4% overall response) and those who underwent autologous stem cell transplantation after PD-1 therapy had significantly improved progression-free survival rates (100% vs 53.5%), suggesting that this treatment strategy can enhance long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of programmed death-1 inhibitor in the treatment of relapsed/refractory classical Hodgkin's lymphoma]. Shan, DD., Liu, HM., Liu, W., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

First-line treatment of Hodgkin's lymphoma. [2007]

2. England pubmed.ncbi.nlm.nih.gov

Advances in CD30- and PD-1-targeted therapies for classical Hodgkin lymphoma. [2020]

3. China pubmed.ncbi.nlm.nih.gov

[Clinical features and prognosis of CD20-positive classical Hodgkin lymphoma]. [2018]

4. Italy pubmed.ncbi.nlm.nih.gov

Efficacy of nivolumab as checkpoint inhibitor drug on survival rate of patients with relapsed/refractory classical Hodgkin lymphoma: a meta-analysis of prospective clinical study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Novel agents in the therapy of Hodgkin lymphoma. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

A real-world analysis of PD1 blockade from the Rete Ematologica Pugliese (REP) in patients with relapse/refractory Hodgkin's lymphoma. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Checkpoint Inhibition in Hodgkin Lymphoma - a Review. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Long-term survival benefit of anti-PD-1 therapy in patients with relapsed or refractory classical Hodgkin lymphoma. [2023]

9. Japan pubmed.ncbi.nlm.nih.gov

Anti-programmed cell death-1 monoclonal antibody therapy before or after allogeneic hematopoietic cell transplantation for classic Hodgkin lymphoma: a literature review. [2022]

10. China pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of programmed death-1 inhibitor in the treatment of relapsed/refractory classical Hodgkin's lymphoma]. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy in Relapsed or Refractory Classic Hodgkin's Lymphoma Treated with PD-1 Inhibitors: A Meta-Analysis of 9 Prospective Clinical Trials. [2022]

12. Japan pubmed.ncbi.nlm.nih.gov

Lymphocyte-depleted classic Hodgkin lymphoma with primary extranodal disease: Two cases that highlight the combination of immunodeficiency and immune escape in the pathogenesis. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

PD-L1 Immunohistochemistry Highlights Bone Marrow Involvement by Classic Hodgkin Lymphoma in Staging Biopsies: Implications for Diagnosis and Tumor Microenvironment Alterations. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of chemotherapy after anti-PD-1 blockade failure for relapsed and refractory Hodgkin lymphoma. [2021]