What is the mechanism of action of this treatment?

The most common treatments for T-Cell Lymphoma include ITK inhibitors like CPI-818, which target the interleukin-2-inducible T-cell kinase essential for T-cell receptor signaling and proliferation. By inhibiting ITK, these drugs aim to reduce the growth and survival of malignant T-cells. Other treatments include chemotherapy, which targets rapidly dividing cells, and immunotherapy, which boosts the body's immune response against cancer cells. Understanding these mechanisms is crucial for T-Cell Lymphoma patients to select the most effective treatment strategy tailored to their disease.

What side effects are associated with this type of intervention?

Common treatments for T-Cell Lymphoma, including ITK inhibitors like CPI-818, often have side effects such as cytopenias (low blood cell counts), hepatotoxicity (liver damage), and gastrointestinal issues (nausea, vomiting, diarrhea). Other kinase inhibitors and chemotherapy agents used in T-Cell Lymphoma can also cause fatigue, infections due to immunosuppression, and skin reactions. It's important to discuss with a healthcare provider to understand the specific side effects and management strategies for each treatment option.

What prior FDA approvals exist?

The FDA has approved several treatments for T-Cell Lymphoma, including monoclonal antibodies, chemotherapy agents, and targeted therapies. Notable examples include brentuximab vedotin, a CD30-directed antibody-drug conjugate, and pralatrexate, a folate analog metabolic inhibitor. While CPI-818 is an ITK inhibitor, specific FDA-approved ITK inhibitors for T-Cell Lymphoma are not mentioned. However, the development of CPI-818 represents a novel approach targeting the interleukin-2-inducible tyrosine kinase pathway, which is a promising area of research in the treatment of relapsed/refractory T-Cell Lymphoma.

What other types of research exist?

Promising alternatives to CPI-818 for T-Cell Lymphoma patients include: 1) Mogamulizumab, a monoclonal antibody targeting CCR4, which has shown efficacy in relapsed/refractory T-cell lymphoma. 2) Brentuximab vedotin, an antibody-drug conjugate targeting CD30, approved for certain types of T-cell lymphoma. 3) Chimeric Antigen Receptor (CAR) T-cell therapies, which are being explored in clinical trials for T-cell lymphomas. 4) Pralatrexate, a folate analog metabolic inhibitor, approved for relapsed/refractory peripheral T-cell lymphoma. These alternatives offer different mechanisms of action and have shown promise in clinical settings.

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Interleukin-2-inducible Tyrosine Kinase Inhibitor

CPI-818 for T-Cell Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Corvus Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

Histologically confirmed evidence of T-cell lymphoma

At least 2 standard therapies for advanced or recurrent disease or had a disease for which there is no more than one established therapy.

Must not have

History of invasive prior malignancy that required systemic therapy within last 3 years.

Females who are pregnant, lactating, or intend to become pregnant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new pill called CPI-818 for patients with T-cell lymphoma that hasn't responded to other treatments. The pill works by blocking a protein that helps cancer cells grow.

Who is the study for?

This trial is for adults over 18 with T-cell lymphoma that's come back or hasn't responded to at least two standard treatments, or where only one treatment exists. They should have measurable disease signs, good organ function, and be fairly active (ECOG status of 0 or 1). People who've had certain transplants, use strong CYP3A affecting drugs, have primary immunodeficiency, recent serious infections, are pregnant/lactating women or those planning pregnancy can't join.

What is being tested?

The study tests CPI-818—an oral drug targeting a specific protein in the immune system—for safety and effectiveness against different types of T-cell lymphoma that haven't improved after previous treatments. It's an early-stage trial (Phase 1/1b) where participants will take CPI-818 alone to see how well it works and what doses are safe.

What are the potential side effects?

Since this is a first-in-human study for CPI-818, detailed side effects aren't fully known yet. However, potential risks may include typical reactions related to immune system modulation such as fatigue, nausea, rash or more severe immune-related conditions.

Eligibility Criteria

Inclusion Criteria

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

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My diagnosis is T-cell lymphoma confirmed by tissue analysis.

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I've had at least 2 treatments for my advanced illness, or there's only one treatment for it.

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My cancer can be measured by tests.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I had cancer that needed treatment throughout my body in the last 3 years.

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I am not pregnant, breastfeeding, nor planning to become pregnant.

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I am currently taking medication that suppresses my immune system.

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I have had a stem cell transplant from a donor.

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I am not taking strong drugs that affect liver enzyme CYP3A.

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

2Treatment groups

Experimental Treatment

Group I: CPI-818 Dose Expansion phaseExperimental Treatment1 Intervention

Participants with different T-cell lymphoma sub-types will receive CPI-818 capsules at the specific dose selected from the Dose escalation phase of the study. CPI-818 capsules at the selected dose will be taken orally, twice per day until disease progression or CR for \> 2 months.

Group II: CPI-818 Dose EscalationExperimental Treatment1 Intervention

Participants will receive CPI-818 capsule, orally, twice per day at an assigned dose, till disease progression, complete response or remission (CR) for \>2 months or if dose determined to be unsafe.

0 / 9Eligibility 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 T-Cell Lymphoma include ITK inhibitors like CPI-818, which target the interleukin-2-inducible T-cell kinase essential for T-cell receptor signaling and proliferation. By inhibiting ITK, these drugs aim to reduce the growth and survival of malignant T-cells. Other treatments include chemotherapy, which targets rapidly dividing cells, and immunotherapy, which boosts the body's immune response against cancer cells. Understanding these mechanisms is crucial for T-Cell Lymphoma patients to select the most effective treatment strategy tailored to their disease.