Clinical trial · Interventional
A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
A Phase 1, First-in-Human, Dose Escalation Study of JNJ-88998377 in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
NCT06470438CI-TRIAL-00124401active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The main purpose of this study is to characterize safety and to determine the recommended phase 2 dose (RP2D) for JNJ-88998377 (Part A: Dose Escalation), to further assess the safety of JNJ-88998377 at the RP2D (Part B: Dose Expansion).
Conditions
Conditions (3)
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, Non-Hodgkin | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Refractory B-Cell NHL | — | UNRESOLVED | — |
| Relapsed B-cell NHL | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JNJ-88998377 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A: Dose Escalation
- description
- Participants will receive JNJ-88998377 at a selected starting dose. Subsequent dose levels and schedules will be selected based on the review of all available data to establish recommended Phase 2 dose (RP2D).
- interventionNames
- Drug: JNJ-88998377
- type
- EXPERIMENTAL
- label
- Part B: Dose Expansion
- description
- Participants will receive JNJ-88998377 at RP2D determined in Part A. Additional expansion cohort(s) may be added with a lower RP2D(s), or different dose schedule(s) based on all available data.
- interventionNames
- Drug: JNJ-88998377
Primary outcomes (2)
- measure
- Parts A and B: Number of Participants with Adverse Events (AEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants have histologically or cytologically confirmed B-cell non-Hodgkin's Lymphoma (NHL) according to the 2022 World Health Organization (WHO) classification with relapsed or refractory disease * Participants have measurable disease or meet all requirements for adequate response assessment as defined by the appropriate disease response criteria at screening * Participants have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participants have a life expectancy of greater than or equal to (\>=) 12 weeks * Be willing and able to adhere to the lifestyle restrictions specified in the protocol Exclusion Criteria: * Participant with active or prior history of B-cell NHL involving the central nervous system (CNS) and leptomeningeal involvement * History of malignancy (other than the disease under study in the cohort to which the participant is assigned) within 1 year prior to the first administration of study treatment. * For Part A and B: Participant having known allergies, hypersensitivity, or intolerance to the excipients of JNJ-88998377 * Participant had major surgery or had significant traumatic injury within 30 days before first dose of study treatment or has not recovered from surgery and must not have major surgery planned during the time the participant is receiving study treatment * Participant received an autologous stem cell transplant less than or equal to (\<=) 3 months before the first dose of study treatment
References
Publications (0)
Data not yet available
No reference posted for this study.