What side effects are associated with this type of intervention?

Common treatments for lymphoma, such as chemotherapy, radiation, and targeted therapies, can have a range of side effects. Chemotherapy often leads to nausea, fatigue, hair loss, and increased risk of infections due to lowered blood cell counts. Radiation therapy can cause skin irritation, fatigue, and long-term risks like secondary cancers. Targeted therapies, including those similar to CS5001, may cause side effects such as fatigue, diarrhea, liver problems, and skin rashes. Long-term effects can include cardiotoxicity, infertility, and neurocognitive issues, particularly in younger patients.

What prior FDA approvals exist?

Several FDA-approved drugs for the treatment of lymphoma include rituximab, ofatumumab, and obinutuzumab, which are anti-CD20 monoclonal antibodies. These drugs target the CD20 protein on the surface of B-cells, leading to cell death. Additionally, kinase inhibitors like ibrutinib and acalabrutinib, which inhibit Bruton's tyrosine kinase (BTK), have been approved for certain types of lymphoma. These treatments share a targeted approach similar to the experimental drug CS5001, focusing on specific pathways to combat cancer cells.

What other types of research exist?

Promising novel alternatives to CS5001 for lymphoma patients in 2024 include: 1) Immune checkpoint inhibitors such as pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways. 2) CAR T-cell therapies like axicabtagene ciloleucel and tisagenlecleucel, which have shown significant efficacy in relapsed or refractory lymphoma. 3) Bispecific T-cell engagers (BiTEs) such as blinatumomab, which direct T-cells to target lymphoma cells. 4) Novel monoclonal antibodies like polatuzumab vedotin, which deliver cytotoxic agents directly to cancer cells. These therapies have demonstrated promising results in clinical trials and offer new hope for lymphoma patients.

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Unknown

CS5001 for Advanced Cancers

Phase 1

Recruiting

Research Sponsored by CStone Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For solid tumor patients of dose escalation, they must have pathologically confirmed, unresectable advanced solid tumor with disease progression on or after at least 1 line of prior systemic therapy.

Female subjects of childbearing potential must have a negative serum pregnancy test.

Must not have

Women who are pregnant or breastfeeding.

Significant cardiovascular disease within 6 months prior to the first dose of the study drug.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up about 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called CS5001 to see if it is safe and effective for patients with advanced blood-related and solid cancers. The drug aims to attack and stop the growth of cancer cells.

Who is the study for?

This trial is for adults with advanced solid tumors or lymphomas that have worsened after treatment. They must have at least one measurable tumor, a life expectancy over 3 months, good performance status and organ function, agree to provide tissue samples and use contraception. Not eligible if they've had certain other cancers, active infections or HIV/AIDS, recent heart issues or treatments, are pregnant/breastfeeding, or have untreated brain metastases.

What is being tested?

The study tests CS5001 in patients with advanced tumors/lymphomas who've seen their disease progress after prior therapies. It's the first time this drug is being tried in humans (FIH), aiming to assess its safety and early effectiveness.

What are the potential side effects?

As CS5001 is experimental and this trial marks its first use in humans, specific side effects are unknown but may include typical reactions related to cancer drugs such as fatigue, nausea, risk of infection and potential impact on blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My solid tumor is advanced, cannot be surgically removed, and has worsened after treatment.

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I am of childbearing age and have a negative pregnancy test.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have Hodgkin or B-cell non-Hodgkin lymphoma that has worsened after 2 treatments.

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I have MCL, DLBCL, or TNBC and have had at least two treatments, including one for MCL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have not had serious heart problems in the last 6 months.

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I have an immune system disorder or need steroids for another health issue.

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I have brain tumors or lymphoma that need treatment.

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I haven't had cancer treatment or major surgery in the last 3 weeks.

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I have swelling, fluid around my heart or in my abdomen needing treatment, or a history of blood vessel issues.

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I haven't had any infections needing treatment in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ about 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~about 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and about 6 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

Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part)

Recommended Phase 2 Dose(RP2D) of CS5001 (for dose escalation part)

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: Dose expansionExperimental Treatment1 Intervention

Group II: Dose escalationExperimental Treatment1 Intervention

0 / 12Eligibility criteria met

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 lymphoma include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as Bruton tyrosine kinase (BTK) inhibitors and BCL2 inhibitors, work by specifically targeting and inhibiting pathways crucial for cancer cell survival and proliferation. Immunotherapies, including monoclonal antibodies like rituximab, enhance the immune system's ability to recognize and destroy cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Understanding these mechanisms is crucial for lymphoma patients as it helps in selecting the most effective treatment based on the specific characteristics of their disease, potentially improving outcomes and minimizing side effects.

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