CPI-818 for T-Cell Lymphoma

Not currently recruiting at 32 trial locations

Overseen By Director Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Corvus Pharmaceuticals, Inc.

Must not be taking: Immunosuppressants, CYP3A modulators

Disqualifiers: Pregnancy, Immunodeficiency, Transplantation, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pill, CPI-818, to determine its safety and effectiveness in treating T-cell lymphoma, a type of blood cancer. It targets individuals whose cancer has returned or has not responded to other treatments. Participants will take the pill twice daily to observe its effects on their cancer. This study may suit those who have tried at least two other treatments for T-cell lymphoma without success. As a Phase 1 trial, the research focuses on understanding how the treatment works 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 does not specify if you need to stop all current medications, but you cannot take strong inhibitors or inducers of CYP3A (a type of enzyme that affects drug metabolism). It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that CPI-818 is likely to be safe for humans?

Research has shown that CPI-818 has been well-tolerated in early studies. Interim results from a study testing different doses of CPI-818 (100 mg, 200 mg, and 400 mg taken twice daily) indicate that participants handled these doses well, suggesting the treatment might be safe.

Additionally, early signs suggest that CPI-818 could help slow the growth of cancer cells in difficult-to-treat cases of T-cell lymphoma, offering hope for those seeking new treatment options.

While the treatment remains under investigation, the evidence so far suggests it is safe and may be beneficial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

CPI-818 is unique because it targets T-cell lymphomas with a novel mechanism of action. Unlike standard treatments like chemotherapy, which broadly attack cancer cells, CPI-818 specifically inhibits ITK (Interleukin-2-inducible T-cell kinase), a crucial enzyme in T-cells. This targeted approach aims to disrupt the cancerous T-cells while sparing healthy cells, potentially reducing side effects. Researchers are excited about CPI-818 because it offers a more precise treatment option that could lead to better outcomes for patients with fewer adverse effects.

What evidence suggests that CPI-818 might be an effective treatment for T-cell lymphoma?

Studies have shown that CPI-818 might be promising for treating T-cell lymphomas, a type of blood cancer. Early results from clinical trials indicated that CPI-818 helped reduce tumors in patients with advanced and difficult-to-treat T-cell lymphomas. Participants in this trial will receive CPI-818 in either a dose escalation or dose expansion phase. This treatment targets ITK, a protein that aids the growth of cancerous T-cells. By blocking ITK, CPI-818 may control the growth of these cancer cells while leaving normal cells unharmed. This suggests CPI-818 could be effective for those whose T-cell lymphoma has returned or is not responding to other treatments. ^{2 3 4 5 6}

Who Is on the Research Team?

Suresh Mahabhashyam, MD, MPH

Principal Investigator

Corvus Pharmaceuticals

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

My organs are working well.

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

Exclusion Criteria

You have a history of weak immune system or have received an organ transplant.

I have not had a serious infection in the last 6 months.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants will receive CPI-818 capsule, orally, twice per day at an assigned dose, until disease progression, complete response or remission for more than 2 months, or if dose is determined to be unsafe.

Variable

Dose Expansion

Participants with different T-cell lymphoma sub-types will receive CPI-818 capsules at the specific dose selected from the Dose Escalation phase.

Variable

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CPI-818

Trial Overview 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.

How Is the Trial Designed?

Group I: CPI-818 Dose Expansion phase Experimental Treatment 1 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 Escalation Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Corvus Pharmaceuticals, Inc.

Lead Sponsor

Trials

9

Recruited

1,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03952078

A Dose Escalation Study Evaluating CPI-818 in Relapsed/ ... This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug.

2. corvuspharma.gcs-web.com corvuspharma.gcs-web.com/news-releases/news-release-details/corvus-pharmaceuticals-presents-updated-data-cpi-818-itk

Corvus Pharmaceuticals Presents Updated Data from CPI-818 ... Recent clinical data in T cell lymphomas suggests that CPI-818 has the potential to control differentiation of T helper cells and enhance immune ...

3. investor.corvuspharma.com investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-present-new-cpi-818-data-international

Corvus Pharmaceuticals to Present New CPI-818 Data at ... Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T ...

4. ashpublications.org ashpublications.org/blood/article/134/Supplement_1/1571/427378/Preliminary-Clinical-Data-from-a-Phase-1-Trial

Preliminary Clinical Data from a Phase 1 Trial with CPI-818, a ... Here we present preclinical evidence that CPI-818 inhibits the proliferation of human malignant T cells with relative sparing of normal lymphocytes.

5. corvuspharma.gcs-web.com corvuspharma.gcs-web.com/news-releases/news-release-details/cpi-818-data-highlights-potential-itk-inhibition-new

CPI-818 Data Highlights Potential for ITK Inhibition as a New ... “The data from our Phase 1/1b trial of CPI-818 for T cell lymphoma continues to be strong, with durable and deep tumor responses observed to ...

6. corvuspharma.com corvuspharma.com/file.cfm/23/docs/TCL_CPI818_Corvus_02.1.2020b.pdf

CPI-818, an Oral Interleukin-2-Inducible T-Cell Kinase ... Interim data from dose escalation part of CPI-818-001 trial shows 100 mg, 200 mg and. 400 mg BID doses were well tolerated. Early signs of clinical activity is ...