Clinical trial · Interventional
Study of HCD122 in Adults With Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies
A Phase IA/II, Multi-center, Open-label Study of HCD122 Administered Intravenously Once Weekly for Four Weeks in Adult Patients With Advanced Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies (CHIR-12.12-LYM-01)
NCT00670592CI-TRIAL-00048909completedPhase 1 / Phase 2ClinicalTrials.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 study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.
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 |
|---|---|---|---|
| Hodgkin's Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HCD122 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- HCD122
- interventionNames
- Drug: HCD122
Primary outcomes (2)
- measure
- Primary endpoints (phase I) - Incidence rate of DLT and AE
- timeFrame
- 2 years
- measure
- Primary endpoint (phase II) - Response rate
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Adverse events by frequency, severity, and duration; pharmacokinetics; immunogenicity; response duration; time to progression
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: Patients may be included in the study if they meet all of the following criteria: * Patients must have confirmed diagnosis of HL or NHL (follicular, marginal zone / MALT, diffuse large B-cell, or mantle cell) per REAL/WHO classification * Patients must have progressed after at least 2 prior therapies (autologous stem cell transplantation is considered as 1 therapy) * Patients must be ≥ 18 years * Patients must have life expectancy \> 3 months * Patient must have adequate laboratory results * Patients must have WHO Performance Status grade 0, 1, or 2 * Patients must have at least one site of measurable disease * Patients must have discontinued any previous monoclonal antibody or radioimmunotherapy, and must have recovered fully from the side effects of that treatment prior to beginning study treatment. * Patients must be willing and able to sign the informed consent form and comply with the study protocol Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: * Patients who have been treated with any anti-CD40 antibody * Patients who have received prior allogeneic stem cell transplant * Patients who have had a prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration * Patients who have history or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis * Women of child-bearing potential (WCBP) who are pregnant or breast feeding. Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.