T-cell LymphomaPhase 1NCT03952078
A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma
A Phase 1 study testing CPI-818 in people with T-cell Lymphoma, run by Corvus Pharmaceuticals, Inc. at 22 sites in 4 countries.
Trial summary
This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-cell Lymphoma
- What is being tested?
- CPI-818
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 3 May 2019to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed evidence of T-cell lymphoma
- Measurable disease.
- Adequate organ function.
- At least 2 standard therapies for advanced or recurrent disease or had a disease for which there is no more than one established therapy.
Who cannot join
- Treatment with systemic immunosuppressive medication.
- History of allogeneic hematopoietic stem cell transplantation.
- History of primary immunodeficiency, solid organ transplantation.
- History of opportunistic infection within 180 days of starting study drug.
- Females who are pregnant, lactating, or intend to become pregnant
- History of invasive prior malignancy that required systemic therapy within last 3 years.
- Concomitant use of strong inhibitors or inducers of CYP3A.
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
South Korea7 sites
Inje University Busan-Paik Hospital
Busan, 47392
Pusan National University Hospital
Busan, 49241
Gachon University
Incheon, 21565
Seoul National University Hospital
Seoul, Gyeonggido, 03080
Asan Medical Center
Seoul, Gyeonggido, 05505
Samsung Medical Center
Seoul, Gyeonggido, 06351
Seoul St. Mary's Hospital
Seoul, Gyeonggido, 06591
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
Ohio State University
Columbus, Ohio, 43210
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Stanford University
Palo Alto, California, 94304
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Washington University
St Louis, Missouri, 63110
China5 sites
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100052
Beijing Boren Hospital
Beijing, Beijing Municipality, 100142
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Henan Cancer Hospital
Henan, Zhengzhou, 450003
Shanghai East Hospital
Pudong, Shanghai Municipality, 200136
Australia4 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Liverpool Hospital
Liverpool, New South Wales, 2170
Epworth Healthcare
Melbourne, Victoria, 3002
About this study
Official title: A Phase 1/1b Dose-Escalation Trial Evaluating CPI-818, an Oral Interleukin-2-Inducible T-Cell Kinase Inhibitor, in Subjects With Relapsed/Refractory T-Cell Lymphoma
This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug.
Read the detailed description
This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug. This trial is composed of dose escalation and dose expansion cohorts.
- Conditions
- T-cell Lymphoma
- Being tested
- CPI-818
- Keywords
- CTCL, PTCL
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPI-818Drug
Interleukin-2 inducible T-cell Kinase Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| CPI-818 Dose Escalation | Experimental | 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. Receives: Drug: CPI-818 |
| CPI-818 Dose Expansion phase | Experimental | 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. Receives: Drug: CPI-818 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature, and severity of adverse events following treatment with CPI 818 to establish the safety and tolerability with increasing dose
Measured: First dose until 30 days after treatment stop
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
Measured: Up to approximately 21 days after first dose
Secondary outcomes (5)
Area under the curve (AUC) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818
Measured: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.
Maximum serum concentration (Cmax) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818
Measured: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.
Objective response rate per Laguno Classification for CTCL and Consensus Statement for Response for CTCL to assess the anti-tumor activity of CPI 818 in subjects with R/R T cell lymphoma
Measured: From start of treatment through end of study treatment, up to approximately 24 months
Evaluate total percentage of tumor gene expression in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.
Measured: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.
Evaluate overall percentage of malignant cells in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.
Measured: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start3 May 2019
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for T-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 151 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corvus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suresh Mahabhashyam, MD, MPH, Study director, Corvus Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952078
- Sponsor's protocol ID
- CPI-818-001
- Status last verified
- Oct 2026
- First submitted
- 7 May 2019
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Miller RA, Ding N, Reneau JC, Song Y, Yoon DH, Feldman TA, Yannakou CK, Kim WS, Gasiorowski R, Kim YH, Khodadoust MS, Radeski D, Giri P, Shin HJ, Yoon SS, Mehta-Shah N, Akilov OE, Khot AS, Sungala NP, Mahabhashyam S, Wilcox RA. Phase 1 Trial with Soquelitinib, a Selective ITK Inhibitor for Treatment of Relapsed/Refractory T Cell Lymphomas. Blood. 2026 Aug 25:blood.2026034704. doi: 10.1182/blood.2026034704. Online ahead of print.
PubMed 42640855
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Dose-Escalation Trial Evaluating CPI-818, an Oral Interleukin-2-Inducible T-Cell Kinase Inhibitor, in Subjects With Relapsed/Refractory T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03952078
- Acronym / sponsor ID
- CPI-818-001
- Conditions
- T-cell Lymphoma
- Keywords
- CTCL, PTCL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- Corvus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 May 2019 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug.
Detailed description
This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug. This trial is composed of dose escalation and dose expansion cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPI-818 Dose Escalation | Experimental | Drug: CPI-818Participants 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. |
| CPI-818 Dose Expansion phase | Experimental | Drug: CPI-818Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult subjects age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed evidence of T-cell lymphoma
- Measurable disease.
- Adequate organ function.
Key exclusion criteria (7 listed)
- Treatment with systemic immunosuppressive medication.
- History of allogeneic hematopoietic stem cell transplantation.
- History of primary immunodeficiency, solid organ transplantation.
- History of opportunistic infection within 180 days of starting study drug.
- Females who are pregnant, lactating, or intend to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPI-818Interleukin-2 inducible T-cell Kinase Inhibitor | Drug | CPI-818 Dose Escalation, CPI-818 Dose Expansion phase |
Primary outcome
Incidence, nature, and severity of adverse events following treatment with CPI 818 to establish the safety and tolerability with increasing dose
Time frame: First dose until 30 days after treatment stop
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
Time frame: Up to approximately 21 days after first dose
5 secondary outcomes
Area under the curve (AUC) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818
Time frame: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.
Maximum serum concentration (Cmax) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818
Time frame: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.
Objective response rate per Laguno Classification for CTCL and Consensus Statement for Response for CTCL to assess the anti-tumor activity of CPI 818 in subjects with R/R T cell lymphoma
Time frame: From start of treatment through end of study treatment, up to approximately 24 months
Evaluate total percentage of tumor gene expression in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.
Time frame: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.
Evaluate overall percentage of malignant cells in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment.
Time frame: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Derived from this study: PubMed 42640855Miller RA, Ding N, Reneau JC, Song Y, Yoon DH, Feldman TA, Yannakou CK, Kim WS, Gasiorowski R, Kim YH, Khodadoust MS, Radeski D, Giri P, Shin HJ, Yoon SS, Mehta-Shah N, Akilov OE, Khot AS, Sungala NP, Mahabhashyam S, Wilcox RA. Phase 1 Trial with Soquelitinib, a Selective ITK Inhibitor for Treatment of Relapsed/Refractory T Cell Lymphomas. Blood. 2026 Aug 25:blood.2026034704. doi: 10.1182/blood.2026034704. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suresh Mahabhashyam, MD, MPH study director
Corvus Pharmaceuticals
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPI-818 in people with T-cell Lymphoma, run by Corvus Pharmaceuticals, Inc. at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in South Korea, United States, China, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, nature, and severity of adverse events following treatment with CPI 818 to establish the safety and tolerability with increasing dose (time frame: First dose until 30 days after treatment stop). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03952078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.