Lymphoma, Non-Hodgkin, Refractory B-Cell NHL, Relapsed B-cell NHL
Conditions
Brief summary
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).
Interventions
DRUGJNJ-88998377
JNJ-88998377 will be administered.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parts A and B: Number of Participants with Adverse Events (AEs) | Upto 3 years 4 months | An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product. |
| Part A: Number of Participants with Dose Limiting Toxicity (DLTs) | Cycle 1 (21 days) | Number of participant with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematological or hematological toxicity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of JNJ-88998377 | Up to first 12 weeks | Plasma concentration of oral dose of JNJ-88998377 will be assessed. |
| Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377 | Up to first 12 weeks | Area under the plasma concentration versus time curve during a dosing interval (τ) at steady-state concentration of JNJ-88998377 will be reported. |
| Maximum Plasma Concentration (Cmax) of JNJ-88998377 | Up to first 12 weeks | Cmax of JNJ-88998377 will be reported. |
| Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377 | Up to first 12 weeks | Cmin of JNJ-88998377 will be reported. |
| Percentage of Participants With Overall Response (OR) | Up to 3 years 4 months | OR is defined as the percentage of participants who have a best response of partial response (PR) or better per investigator assessment according to disease-specific response criteria. |
| Time to Response (TTR) | From first dose of study treatment until first response of PR or better (up to 3 years and 4 months) | TTR is defined for participants who achieved a response of PR or better as the time from the first dose of study treatment to the first response of PR or better per investigator assessment according to disease-specific response criteria. |
| Duration of Response (DOR) | From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months) | DOR is defined for participants who achieved a response of PR or better as the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death. |
Countries
China, Italy, Japan, Poland, South Korea, Taiwan, Turkey (Türkiye)
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed