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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment through end of study treatment, up to approximately 24 months

Awards & highlights

Study Summary

This trial is studying a new drug to treat T-cell lymphoma. The drug will be given to see if it is safe and works against the cancer.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment through end of study treatment, up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment through end of study treatment, up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment through end of study treatment, up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and nature of dose limiting toxicities (DLTs) of CPI 818 to establish either the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of CPI 818

Incidence, nature, and severity of adverse events following treatment with CPI 818 to establish the safety and tolerability with increasing dose

Secondary outcome measures

Area under the curve (AUC) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818

Evaluate overall percentage of malignant cells in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.

Evaluate total percentage of tumor gene expression in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.

+2 more

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Corvus Pharmaceuticals, Inc.Lead Sponsor

7 Previous Clinical Trials

790 Total Patients Enrolled

Mehrdad Mobasher, MD, MPHStudy DirectorCorvus Pharmaceuticals

1 Previous Clinical Trials

502 Total Patients Enrolled

Suresh Mahabhashyam, MD, MPHStudy DirectorCorvus Pharmaceuticals

Media Library

CPI-818 (Interleukin-2-inducible Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03952078 — Phase 1

T-Cell Lymphoma Research Study Groups: CPI-818 Dose Escalation, CPI-818 Dose Expansion phase

T-Cell Lymphoma Clinical Trial 2023: CPI-818 Highlights & Side Effects. Trial Name: NCT03952078 — Phase 1

CPI-818 (Interleukin-2-inducible Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03952078 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned CPI-818 for public use?

"There is limited clinical evidence to support CPI-818's safety, resulting in it receiving a score of 1."

Answered by AI

Are there any enrollment possibilities for this clinical trial at present?

"As of June 20th 2022, this clinical trial is actively looking for participants. Data hosted on clinicaltrials.gov indicates that the initial posting was made back in May 3rd 2019."

Answered by AI

How many individuals are participating in this research endeavor?

"To ensure the success of this medical trial, 151 people that meet the specified criteria must enroll. Participants in Ohio can join at Ohio State University in Columbus and those from Michigan may participate at University of Michigan in Ann Arbor."

Answered by AI

What geographic areas are providing access to this investigation?

"This clinical study is accepting patients at 7 different sites across the United States. These include Ohio State University in Columbus, University of Michigan in Ann Arbor, and Stanford University in Palo Alto among 4 other medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma

2019. "A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03952078.