A Phase 1, First-in-Human, Dose Escalation Study of JNJ-88998377 in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Yoshinari Nozomi
Janssen Pharmaceutical K.K.
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
+81-120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Medical Information Center
Janssen Pharmaceutical K.K.
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
+81-120-183-275
DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Recruiting
Aug. 27, 2024
Aug. 06, 2024
160
Interventional
non-randomized controlled trial
open(masking not used)
active control
single assignment
treatment purpose
- 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
- 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
18age old over
No limit
Both
Lymphoma, Non-Hodgkin
Refractory B-Cell NHL
Relapsed B-cell NHL
Experimental: Part A: Dose Escalation
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).
Drug: JNJ-88998377
JNJ-88998377 will be administered.
Experimental: Part B: Dose Expansion
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.
Drug: JNJ-88998377
JNJ-88998377 will be administered.
1. Parts A and B: Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or noninvestigational) product. It does not necessarily have a causal relationship with the investigational product.
[Time Frame: Upto 3 years 4 months]
2. Part A: Number of Participants with Dose Limiting Toxicity (DLTs)
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.
[Time Frame: Cycle 1 (21 days)]
3. Plasma Concentration of JNJ-88998377
Plasma concentration of oral dose of JNJ-88998377 will be assessed.
[Time Frame: Up to first 12 weeks]
4. Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (t) At Steady-State of JNJ-88998377
Area under the plasma concentration versus time curve during a dosing interval (t) at steady-state concentration of JNJ-88998377 will be reported.
[Time Frame: Up to first 12 weeks]
5. Maximum Plasma Concentration (Cmax) of JNJ-88998377
Cmax of JNJ-88998377 will be reported.
[Time Frame: Up to first 12 weeks]
6. Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377
Cmin of JNJ-88998377 will be reported.
[Time Frame: Up to first 12 weeks]
7. Percentage of Participants With Overall Response (OR)
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 Frame: Up to 3 years 4 months]
8. Time to Response (TTR)
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.
[Time Frame: From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)]
9. Duration of Response (DOR)
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.
[Time Frame: From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months)]
Janssen Pharmaceutical K.K.
The Cancer Institute Hospital of JFCR Institutional Review Board
3-8-31 Ariake, Koto-ku, Tokyo
Approval
June. 12, 2024
Yes
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
NCT06470438
ClinicalTrials.gov
2023-509258-71-00
EUCT number
China/Italy/Korea Republic Of/Taiwan Province Of China/ Turkiye/Poland
