Clinical trial · Interventional
A Study of ATG-010 in Combination With ATG-008 in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
An Open Label, Phase Ⅰb Study of ATG-010 in Combination With ATG-008 in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)
NCT05354362CI-TRIAL-00064790MATCHterminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 is an Open label, Phase Ⅰb Study of ATG-010 in Combination With ATG-008 in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)
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 |
|---|---|---|---|
| Relapsed/Refractory Diffuse Large B-cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATG-010 and ATG-008 | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ATG-010 and ATG-008
- description
- ATG-010 and ATG-008 should be taken 6 hours apart on a PK sampling day
- interventionNames
- Combination Product: ATG-010 and ATG-008
Primary outcomes (2)
- measure
- MTD
- timeFrame
- the last patient on study has completed 12 months of follow-up
- description
- Maximum Tolerated Dose
- measure
- RP2D
- timeFrame
- the last patient on study has completed 12 months of follow-up
- description
- Recommended Phase 2 Dose
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years old. 2. ECOG Performance score of ≤2. 3. Estimated life expectancy of \>3 months. 4. Previously treated, pathologically confirmed DLBCL 5. Patients must have received at least 2 but no more than 5 previous systemic regimens (for non-DH/TH, non-DE DLBCL and DLBCL not transformed from FL or CLL), or at least 1 but no more than 5 previous systemic regimens (for DH/TH, DE DLBCL, and DLBCL transformed from FL or CLL) for the treatment of their DLBCL. 1. Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy. 2. Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of therapy. 3. Any maintenance therapy will not be counted as a separate line of systemic therapy. 4. Radiation with curative intent for localized DLBCL will not be counted as 1 line of therapy 6. Documented radiographic evidence of progressive DLBCL of the last line (or refractory DLBCL) prior to the first dosing. Exclusion Criteria: 1. Female patients who are pregnant or lactating 2. DLBCL with mucosa-associated lymphoid tissue \[MALT\] lymphoma, or primary mediastinal (thymic) large B-cell lymphoma (PMBL) 3. Known central nervous system lymphoma or meningeal involvement (for dose expansion phase, patients with stable CNS disease could be considered). 4. Patients eligible for high-dose chemotherapy with autologous stem cell transplantation rescue (the Investigator must provide detailed documentation for ineligibility) 5. Use of any standard or experimental anti-DLBCL therapy (including radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) \<21 days prior to Cycle 1 Day 1. 6. Autologous stem cell transplant (SCT) \<6 months or prior allogeneic SCT, or CAR-T cell infusion \<6 months prior to Cycle 1. 7. Major surgery within 4 weeks of the first dose of study treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.