Clinical trial · Interventional
A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma
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
NCT03952078CI-TRIAL-00088604active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| T-cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPI-818 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CPI-818 Dose Escalation
- description
- 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.
- interventionNames
- Drug: CPI-818
- type
- EXPERIMENTAL
- label
- CPI-818 Dose Expansion phase
- description
- 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.
- interventionNames
- Drug: CPI-818
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDMiller 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. PMID 42640855