What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, such as chemotherapy, immunotherapy, and targeted therapies, often come with a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, increased risk of infection, and low blood cell counts. Immunotherapy, including checkpoint inhibitors, may lead to immune-related adverse effects like colitis, hepatitis, pneumonitis, and endocrinopathies. Targeted therapies, such as monoclonal antibodies and kinase inhibitors, can result in side effects like infusion reactions, hypertension, diarrhea, and liver toxicity. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies like rituximab, ofatumumab, and obinutuzumab, which target the CD20 antigen on B-cells. Combination therapies such as R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) are also standard. Additionally, newer agents like CAR T-cell therapies (e.g., axicabtagene ciloleucel) and small molecule inhibitors (e.g., idelalisib) have been approved for specific subtypes of NHL, including DLBCL. These treatments aim to improve response rates and progression-free survival in patients with advanced or refractory disease.

What other types of research exist?

Promising novel alternatives to RNK05047 for Non-Hodgkin's Lymphoma patients include: 1) AZD4573, a CDK9 inhibitor that impairs cancer-promoting gene expression and is effective in hematologic malignancies. 2) RO6870810, a bromodomain and extra-terminal (BET) protein inhibitor, which has shown preliminary single-agent activity in diffuse large B-cell lymphoma (DLBCL). 3) Venetoclax, a BCL-2 inhibitor, particularly in combination with obinutuzumab, which has demonstrated improved progression-free survival in chronic lymphocytic leukemia (CLL) and may be applicable to NHL.

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Monoclonal Antibodies

RNK05047 for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Ranok Therapeutics (Hangzhou) Co., Ltd.

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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests RNK05047, a new drug, on patients with advanced solid tumors, including DLBCL. The drug is given regularly through an IV to find the safest and most effective dose.

Who is the study for?

This trial is for adults with advanced solid tumors or diffuse large B-cell lymphoma who've run out of standard treatment options. They must be in fairly good health, understand the study, and agree to use effective birth control. Pregnant women, those with certain infections like HIV or hepatitis, and people with unresolved side effects from past cancer treatments can't join.

What is being tested?

The trial is testing RNK05047 given through an IV to see if it's safe and works against advanced cancers. It has two parts: first finding the right dose (dose escalation) and then giving that dose to more people (cohort expansion).

What are the potential side effects?

Since this is a first-in-human study for RNK05047, specific side effects are not yet known but may include typical reactions related to IV infusions such as pain at injection site, fever, chills, nausea or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RNK05047Experimental Treatment1 Intervention

Dose-escalation of RNK05047 IV infusion

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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

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cells, including cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as Bruton tyrosine kinase (BTK) inhibitors and BCL2 inhibitors, specifically target molecular pathways crucial for the survival and proliferation of lymphoma cells, thereby minimizing damage to normal cells. Immunotherapy, including monoclonal antibodies and CAR-T cell therapy, harnesses the body's immune system to recognize and destroy cancer cells. These mechanisms are crucial for NHL patients as they offer more precise and potentially less toxic treatment options compared to traditional chemotherapy.