CHO-H01 for Lymphoma

Recruiting at 8 trial locations

Overseen By Tanny Tsao

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

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 All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

37 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CHO-H01 for individuals with relapsed or stubborn CD20+ non-Hodgkin's lymphoma, a type of blood cancer. Initially, the study determines the safety of CHO-H01 and identifies the optimal dose. Later, the trial evaluates how well CHO-H01 works with lenalidomide in treating low-grade forms of this lymphoma. This trial may suit those diagnosed with low-grade non-Hodgkin's lymphoma, such as follicular or marginal zone lymphoma, who have relapsed after previous treatments. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that CHO-H01 is being tested for safety and effectiveness in treating certain types of non-Hodgkin's lymphoma. This includes its use with lenalidomide, a drug already used for some cancers. While specific safety data for CHO-H01 is still being collected, early trials aim to identify the safest dose levels.

Lenalidomide, when combined with other treatments, is generally safe, but it can have side effects. Common side effects in similar treatments might include fatigue or a decrease in blood cell counts. In the current phase of the trial, researchers are assessing how well patients tolerate CHO-H01. They focus on understanding any possible side effects and determining the best dose.

Prospective trial participants should discuss potential risks and benefits with their healthcare provider, who can offer personalized information based on individual health conditions. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for lymphoma?

CHO-H01 is unique because it introduces a fresh approach to treating lymphoma by exploring a new range of doses and combinations. Unlike traditional chemotherapy, which often targets rapidly dividing cells indiscriminately, CHO-H01 is being tested both alone and in combination with lenalidomide, a drug known for modulating the immune system. This combination aims to enhance the body's natural defenses against cancer while potentially increasing the effectiveness of CHO-H01. Researchers are excited about the potential of CHO-H01 to offer a more targeted attack on lymphoma cells with possibly fewer side effects than conventional treatments.

What evidence suggests that CHO-H01 might be an effective treatment for non-Hodgkin's lymphoma?

Research has shown that CHO-H01 is being tested as a potential treatment for non-Hodgkin's lymphoma, especially when the cancer has returned or hasn't responded to other treatments. Early results are promising, as CHO-H01 effectively targets and attacks cancer cells. In this trial, some participants will receive CHO-H01 alone, while others will receive a combination of CHO-H01 and lenalidomide. Lenalidomide, known to improve outcomes in some types of lymphoma, has shown positive results in treating diffuse large B-cell lymphoma, suggesting it could enhance the effects of CHO-H01. This combination aims to offer an effective treatment option for patients whose lymphoma has relapsed or is resistant to other treatments. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CHO-H01

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Cho Pharma Inc.

Lead Sponsor

Trials

2

Recruited

60+

Published Research Related to This Trial

Brentuximab vedotin, a CD30 antibody-drug conjugate, and PD-1 antibodies like nivolumab and pembrolizumab are highly effective treatments for relapsed and refractory classical Hodgkin lymphoma (cHL), showing promising results in ongoing studies for earlier treatment lines.

These targeted therapies are expected to improve cure rates and decrease long-term toxicity compared to traditional chemotherapy and radiotherapy, potentially transforming the management of cHL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in CD30- and PD-1-targeted therapies for classical Hodgkin lymphoma. Wang, Y., Nowakowski, GS., Wang, ML., et al.[2020]

Hodgkin lymphoma (HL) generally has a good prognosis with standard chemotherapy and radiation, but patients with relapsed or refractory disease face poorer outcomes, highlighting the need for new treatment options.

Novel therapies, including antibody-drug conjugates targeting CD30 and immune checkpoint inhibitors, are showing promise in treating HL, and ongoing trials are investigating their use in combination with existing chemotherapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Nivolumab, a PD1 blocking antibody, shows a high overall objective response rate of 68% in patients with relapsed or refractory classic Hodgkin's lymphoma, indicating its efficacy as a treatment option.

The study suggests that nivolumab has a controllable safety profile, making it a viable long-term treatment alternative compared to traditional therapies for Hodgkin's lymphoma.

NCBI (Pubmed)

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. Amraee, A., Evazi, MR., Shakeri, M., et al.[2022]

In a retrospective analysis of 66 patients with relapsing refractory classical Hodgkin's lymphoma (cHL) treated with PD-1 inhibitors, the overall response rate was 70%, with 47% achieving complete remission and 23% partial remission, indicating strong efficacy in a real-world setting.

The treatment was well-tolerated, with immune-related adverse events mostly being mild (grades 1-2), and no deaths attributed to the therapy, suggesting a favorable safety profile alongside a median overall survival of 65% at 5 years.

NCBI (Pubmed)

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. Gaudio, F., Loseto, G., Bozzoli, V., et al.[2023]

Hodgkin's lymphoma (HL) has become one of the most curable cancers in adults, with about 80% of patients achieving long-term disease-free survival due to substantial clinical advancements.

Current treatment strategies focus on enhancing chemotherapy and radiotherapy effectiveness while reducing side effects, with ongoing trials exploring lower doses and smaller radiation fields, as well as more intense drug combinations for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line treatment of Hodgkin's lymphoma. Klimm, B., Engert, A., Diehl, V.[2007]

In a study of 263 patients with classical Hodgkin lymphoma (CHL), 28.1% were found to be CD20-positive, which was significantly associated with higher rates of Epstein-Barr virus (EBV) infection and specific CHL subtypes, indicating a potential link between CD20 expression and disease characteristics.

CD20 positivity, along with EBV infection, was correlated with poorer progression-free survival (PFS), particularly in patients not receiving local radiotherapy, suggesting that CD20 expression may influence prognosis through its relationship with EBV infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical features and prognosis of CD20-positive classical Hodgkin lymphoma]. Qin, Y., Kang, SY., He, XH., et al.[2018]

In a study of 260 patients with relapsed or refractory classical Hodgkin lymphoma treated with anti-PD-1 therapies, the 3-year progression-free survival rate was 55.1% and the overall survival rate was 89.7%, indicating good long-term outcomes for responders.

Patients who achieved complete remission had significantly better survival rates compared to those with partial remission, highlighting that the extent of response to treatment is crucial for long-term success and suggesting the need for additional treatment strategies for those with partial responses or refractory disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival benefit of anti-PD-1 therapy in patients with relapsed or refractory classical Hodgkin lymphoma. Liu, W., Lin, N., Feng, X., et al.[2023]

Anti-PD1 antibodies, such as nivolumab and pembrolizumab, have been approved for treating relapsed or refractory classical Hodgkin lymphoma (cHL) due to their high response rates and favorable safety profiles.

This review highlights the importance of immune checkpoint inhibitors in overcoming cancer's ability to evade the immune system, and discusses ongoing clinical trials and potential combination therapies to enhance treatment efficacy in cHL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Checkpoint Inhibition in Hodgkin Lymphoma - a Review. Bröckelmann, PJ., Engert, A.[2018]

Anti-PD-1 monoclonal antibodies have shown a high response rate and an acceptable safety profile in patients with relapsed or refractory classic Hodgkin lymphoma (cHL), but most patients eventually relapse after treatment.

Using anti-PD-1 mAbs as bridging therapy before allogeneic hematopoietic cell transplantation (allo-HCT) can be feasible, although it may increase the risk of severe graft-versus-host disease (GVHD); however, survival outcomes remain favorable, especially with posttransplant cyclophosphamide-based GVHD prophylaxis.

NCBI (Pubmed)

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. Ito, A., Kim, SW., Fukuda, T.[2022]

In a meta-analysis of 9 clinical trials involving 731 patients with relapsed or refractory classic Hodgkin's lymphoma, PD-1 inhibitors showed a high overall response rate of 74%, indicating their efficacy in treating this type of cancer.

The treatment was associated with manageable safety profiles, with only 21% of patients experiencing grade ≥3 adverse events, suggesting that PD-1 inhibitors are a tolerable option for patients with cHL.

NCBI (Pubmed)

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. Zhang, X., Chen, L., Zhao, Y., et al.[2022]

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]

The study identifies a strong association between PD-L1 expression and lymphocyte-depleted classic Hodgkin lymphoma (LD-CHL), providing a clearer diagnostic framework for this previously difficult-to-diagnose condition.

Two case studies of elderly patients with LD-CHL revealed unique tumor characteristics and immunohistochemical profiles, but both patients were too frail for treatment and succumbed to the disease within 1 to 15 months, highlighting the aggressive nature of this lymphoma in immunocompromised individuals.

NCBI (Pubmed)

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. Tsuyuki, Y., Kohno, K., Inagaki, Y., et al.[2021]

In a study of 44 bone marrow biopsies from patients with newly diagnosed classic Hodgkin lymphoma (CHL), PD-L1 expression was found to be a highly sensitive marker for detecting bone marrow involvement, with 100% positivity in cases confirmed to have CHL.

PD-L1 staining can aid in diagnosing CHL, especially in challenging cases where Reed-Sternberg cells are sparse, as it was effective in identifying involvement even in previously nondiagnostic biopsies.

NCBI (Pubmed)

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. Xing, W., Mai, N., Dresser, K., et al.[2020]

In a study of 25 patients with relapsed/refractory classical Hodgkin lymphoma, 68% had unsatisfactory responses to anti-PD1 therapy, but subsequent salvage chemotherapy resulted in a 60% overall response rate, indicating that chemotherapy can be effective after PD1 blockade failure.

The median progression-free survival after salvage treatment was 19.1 months, significantly longer than the 8.2 months observed after anti-PD1 therapy, suggesting that chemotherapy can improve outcomes for patients who do not respond to PD1 inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of chemotherapy after anti-PD-1 blockade failure for relapsed and refractory Hodgkin lymphoma. Casadei, B., Argnani, L., Morigi, A., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05950165

A Study to Assess Safety and Efficacy of CHO-H01 As a ... A Study to Assess Safety and Efficacy of CHO-H01 As a Single Agent/​Combined with Lenalidomide in Subjects with Refractory or Relapsed Non-Hodgkin's Lymphoma.

2. trialx.com trialx.com/clinical-trials/listings/231128/a-study-to-assess-safety-and-efficacy-of-cho-h01-in-subjects-with-refractory-or-relapsed-non-hodgkins-lymphoma/

A Study to Assess Safety and Efficacy of CHO-H01 in ... Part 2/Phase 2 will assess the anticancer activity and safety of CHO-H01 in subjects with relapsed/refractory CD20+ non-Hodgkin's lymphoma.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05950165?term=AREA%5BConditionSearch%5D(%22Hodgkin's%20Granuloma%22)%20AND%20AREA%5BInterventionSearch%5D(%22antibodies%22)&rank=8

A Study to Assess Safety and Efficacy of CHO-H01 As ... An adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or ...

4. withpower.com withpower.com/trial/phase-2-lymphoma-2020-90b98

CHO-H01 for Lymphoma 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11976689/

Relapsed/Refractory Follicular Lymphoma: Current ... A real‐world study reported an ORR of 82% and a median PFS of 22 months, confirming its utility across diverse clinical scenarios, including rituximab ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05950165?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Cho%20Pharma%20Inc.%22))&rank=2

A Study to Assess Safety and Efficacy of CHO-H01 As a ... Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-to-assess-safety-and-efficacy-of-cho-h01-in-subjects-with-refractory-or-relapsed-non-hodgkin

A Study to Assess Safety and Efficacy of CHO-H01 As a Single ... Life expectancy of >12 weeks. · Body mass index of 18 to 32 kg/m2. · Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

8. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/411455

A Study to Assess Safety and Efficacy of CHO-H01 As ... Life expectancy of >12 weeks. · Body mass index of 18 to 32 kg/m2. · Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.