Clinical trial · Interventional
Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL
A Phase I/Ib Open-label, Multi-center Dose Escalation Study of JBH492 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)
NCT04240704CI-TRIAL-00096484terminatedPhase 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): Business, strategic, and development considerations and not due to any safety concerns
Summary
Brief summary (as posted)
The purpose of the First-In-Human study was to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkins Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JBH492 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JBH492 single agent
- description
- Patients with R/R CLL or NHL
- interventionNames
- Drug: JBH492
Primary outcomes (6)
- measure
- Incidence and severity of dose limiting toxicities (DLTs)
- timeFrame
- 32 months
- description
- A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value that occurs during the first cycle of treatment with JBH492 and meets any of the protocol specified criteria, unless incontrovertibly related to underlying disease, intercurrent illness or concomitant medications.
- measure
- Incidence and severity of Adverse Events (AEs)
- timeFrame
- 32 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: For patients with CLL: • Confirmed diagnosis of chronic lymphocytic leukemia (CLL) For patients with NHL: * Histologically confirmed diagnosis of B- or T-cell non-Hodgkins lymphoma (NHL). * Must have a site of disease amenable to biopsy, and be suitable and willing to undergo study required biopsies at screening and during therapy. Exclusion Criteria, applicable to both CLL and NHL: * History of anaphylactic or other severe hypersensitivity/infusion reactions to ADCs, monoclonal antibodies (mAbs) and/or their excipients such that the patient in unable to tolerate immunoglobulin/monoclonal antibody administration * Any prior history of treatment with maytansine (DM1 or DM4)-based ADC * Known intolerance to a maytansinoid * Patients with any active or chronic corneal disorders * Patients who have any other condition that precludes monitoring of the retina or fundus * Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and provided that local treatment was completed \>4 weeks before first dose of study treatment. Patients that have been effectively treated for CNS disease and are stable under systemic therapy may be enrolled provided all other inclusion and exclusion criteria are met. Patients who received prophylactic intrathecal treatment are eligible, if treatment discontinued \>5 half-lives prior to the first dose of study treatment * Impaired cardiac function or clinically significant cardiac disease * Known history of Human Immunodeficiency Virus (HIV) infection * Active HBV or HCV infection. Patients whose disease is controlled under antiviral therapy should not be excluded. Patients who are anti-HBcAb positive should be HBsAg negative and HBV-DNA negative to be eligible Other inclusion and exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.