Clinical trial · Interventional
A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Peripheral T- and NK/T-cell Lymphoma
A Phase 1/2, Open-label, Multi-center Study to Evaluate theSafety and Efficacy of Selinexor Combined With Chemotherapy orTislelizumab in Relapsed or Refractory Mature T and NK Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Based on the adjustment of clinical research and development strategy,sponsor decided to terminate the study
Summary
Brief summary (as posted)
This trial is proposed with treatment of ATG-010 combined with chemotherapy regimens which will be chosen by investigators (ICE \[ifosfamide+carboplatin+etoposide\] or GEMOX \[gemcitabine+oxaliplatin\] or Tislelizumab), after treatments of 2 to 6 cycles transferring to ATG-010 monotherapy maintenance treatment, to evaluate the safety, tolerability, and primary efficacy of ATG-010 in R/R PTCL and NK/T-cell lymphoma patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NK/T-cell Lymphoma | — | UNRESOLVED | — |
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GEMOX [gemcitabine+oxaliplatin] | Combination Product | — | UNRESOLVED |
| ICE [ifosfamide+carboplatin+etoposide] | Combination Product | — | UNRESOLVED |
| Tislelizumab | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ATG-010 + ICE
- description
- ATG-010 60 mg/once,total twice in each cycle; on Days 4 and 11
- interventionNames
- Combination Product: ICE [ifosfamide+carboplatin+etoposide]
- type
- EXPERIMENTAL
- label
- ATG-010 + GEMOX
- description
- ATG-010 60 mg/once,total twice in each cycle; on Days 2 and 9
- interventionNames
- Combination Product: GEMOX [gemcitabine+oxaliplatin]
- type
- EXPERIMENTAL
- label
- ATG-010 + Tislelizumab
- description
- ATG 010 40mg/once, will be given on Days 1, 8, and 15 of each cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient is willing to provide written ICF. 2. Age≥ 18 years. 3. R/R PTCL and NK/T-cell lymphoma as confirmed by histological methods according to WHO classification of tumors of lymphoid tissues 2016. 4. Previously received at least one or more standard regimens including anthracycline. 5. Recurrence or the recurrence disease after the last treatment completed. 6. At least one measurable disease per modified efficacy assessment criteria (Cheson 2014). 7. ECOG PS 0 or 1. 8. Any toxicity caused by previously anti-tumor therapy must recovered to ≤ Grade 1 (NCI-CTCAE v5.0) with exception of hearing loss, alopecia, and pigmentation. 9. Expected life time longer than 3 months. Exclusion Criteria: 1. Current have disease or history of central nervous system lymphoma. 2. HBV-DNA positive, or HCV-RNA positive. 3. Patients with a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome. 4. Received major surgery within 4 weeks of first dose of study drug 5. Known received SINE, including ATG-010. 6. Unable to swallow the tablets, suffers from malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may interfere with ATG-010 absorption. 7. Known allergy to ATG-010, or ICE, or GEMOX. 8. A woman who is pregnant or nursing. 9. The investigator considerations on patient's complications or other conditions may affect protocol compliance or may be inappropriate for participation in the study.
References
Publications (1)
- DERIVEDLiu C, Li D, Gao Y, Zhang W, Guo Z, Zhao J, Huang H, Tao R. Selinexor plus tislelizumab in patients with relapsed/refractory natural killer/T-cell lymphoma after failure of PD-1 blockade: the phase 1b TOUCH trial. Oncologist. 2026 Aug 6;31(9):oyag266. doi: 10.1093/oncolo/oyag266. PMID 42438166