151 Participants Needed

CPI-818 for T-Cell Lymphoma

Recruiting at 24 trial locations
DC
Overseen ByDirector Clinical Operations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

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.

What makes the drug CPI-818 unique for treating T-cell lymphoma?

CPI-818 is a novel treatment for T-cell lymphoma that may offer a different approach compared to existing therapies, although specific details about its mechanism or administration are not provided in the available research. T-cell lymphomas, particularly those involving CD8+ cells, are rare and not well-characterized, suggesting that CPI-818 could be addressing a gap in treatment options for these specific subtypes.12345

Research Team

SM

Suresh Mahabhashyam, MD, MPH

Principal Investigator

Corvus Pharmaceuticals

Eligibility Criteria

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.
See 2 more

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.
See 4 more

Timeline

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

Treatment Details

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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Corvus Pharmaceuticals, Inc.

Lead Sponsor

Trials
9
Recruited
1,100+

References

Increased serum CD8 antigen level in childhood Hodgkin's disease relates to advanced stage and poor treatment outcome. [2021]
[Clinicopathological features and prognosis of cytotoxic T-cell lymphoma: analysis of 134 cases]. [2022]
Cutaneous CD8+ Cytotoxic T-Cell Lymphoma Infiltrates: Clinicopathological Correlation and Outcome of 35 Cases. [2020]
Junctional CD8+ cutaneous lymphomas with nonaggressive clinical behavior: a CD8+ variant of mycosis fungoides? [2019]
[Distribution of T-lymphocyte subpopulations in non-Hodgkin's lymphomas]. [2006]