Clinical trial · Interventional
Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma
Phase 1, Multicenter, Open-Label Study of the Antibody-Drug Conjugate TRPH-222 in Subjects With Relapsed and/or Refractory B-Cell Lymphoma
NCT03682796CI-TRIAL-00058602completedPhase 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, multi-center, open-label study of TRPH-222 monotherapy in subjects with relapsed and/or refractory B-cell NHL. The study will be conducted in two Stages: Dose-Escalation, Dose-Expansion.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Lymphoma, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Mantle-Cell | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Marginal Zone | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TRPH-222 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Escalation
- description
- Estimated to be \<31 subjects across multiple centers
- interventionNames
- Drug: TRPH-222
- type
- EXPERIMENTAL
- label
- Expansion
- description
- Estimated to be \<121 subjects across multiple centers
- interventionNames
- Drug: TRPH-222
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- 21 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Age ≥ 18 years at the time of signing the informed consent * Histologically confirmed (2016 WHO lymphoma classification) B-cell NHL that is DLBCL, FL (including transformed FL), MZL, or MCL * Relapsed and/or refractory NHL requiring systemic therapy and have failed, are intolerant to, or are considered ineligible for standard of care anticancer treatments that are known to be potentially curative. Subjects must not be current candidates for HSCT. Participants who refuse standard treatments may also be considered provided that documentation is provided that the subject has been made aware of all therapeutic options * Eastern Cooperative Oncology Group (ECOG) status 0-2 Exclusion Criteria * Presence of a leukemic phase of the lymphoma * "Double hit" or "triple hit" germinal center B cell lymphoma * Previous solid organ allograft (except for corneal transplant) * Peripheral neuropathy \> NCI-CTCAE Grade 1 * Significant organ dysfunction that would preclude study participation * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias * Any other serious active disease or co-morbid medical condition, according to the Investigator's decision or Medical Monitor, that will substantially increase the risk associated with the subject's participation in the study
References
Publications (0)
Data not yet available
No reference posted for this study.