Lymphoma, Non-HodgkinPhase 1NCT06470438
A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
A Phase 1 study testing JNJ-88998377 in people with Lymphoma, Non-Hodgkin and Refractory B-Cell NHL, run by Janssen Research & Development, LLC at 19 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Refractory B-Cell NHL, Relapsed B-cell NHL
- What is being tested?
- JNJ-88998377
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 19 sitesin 7 countries
- Study dates
- 28 May 2024to 29 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 7 countries.
19 sites in 7 countries
China5 sites
Beijing Cancer Hospital
Beijing, 100142
Sun Yat Sen University Cancer Center
Guangzhou, 510062
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, 310002
Fudan University Shanghai Cancer Center
Shanghai, 200032
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300181
Japan3 sites
National Cancer Center Hospital
Chūōku, 104 0045
National Cancer Center Hospital East
Kashiwa, 277-8577
The Cancer Institute Hospital of JFCR
Tokyo, 135 8550
Poland3 sites
Pratia Onkologia Katowice
Katowice, 40 519
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku
Kielce, 25-734
Aidport Sp z o o
Skorzewo, 60-185
Turkey (Türkiye)3 sites
SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi
Ankara, 06200
Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi
Ankara, 06620
Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi
Istanbul, 34010
South Korea2 sites
Seoul National University Hospital
Seoul, 03080
Samsung Medical Center
Seoul, 06351
Taiwan2 sites
National Taiwan University Hospital
Taipei, 10043
Linkou Chang Gung Memorial Hospital
Taoyuan, 33382
About this study
Official title: A Phase 1, First-in-Human, Dose Escalation Study of JNJ-88998377 in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
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).
- Being tested
- JNJ-88998377
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-88998377Drug
JNJ-88998377 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose Escalation | Experimental | 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). Receives: Drug: JNJ-88998377 |
| Part B: Dose Expansion | Experimental | 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. Receives: Drug: JNJ-88998377 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 non-investigational) product. It does not necessarily have a causal relationship with the investigational product.
Measured: Upto 3 years 4 months
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.
Measured: Cycle 1 (21 days)
Secondary outcomes (7)
Plasma Concentration of JNJ-88998377
Plasma concentration of oral dose of JNJ-88998377 will be assessed.
Measured: Up to first 12 weeks
Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377
Area under the plasma concentration versus time curve during a dosing interval (τ) at steady-state concentration of JNJ-88998377 will be reported.
Measured: Up to first 12 weeks
Maximum Plasma Concentration (Cmax) of JNJ-88998377
Cmax of JNJ-88998377 will be reported.
Measured: Up to first 12 weeks
Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377
Cmin of JNJ-88998377 will be reported.
Measured: Up to first 12 weeks
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.
Measured: Up to 3 years 4 months
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.
Measured: From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)
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.
Measured: From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start28 May 2024
- Primary completion29 Oct 2027 (estimated)
- Study completion29 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470438
- Sponsor's protocol ID
- 88998377LYM1001
- Other IDs
- 88998377LYM1001, 2023-509258-71-00, 2023
- Status last verified
- Nov 2026
- First submitted
- 17 Jun 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Dose Escalation Study of JNJ-88998377 in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT06470438
- Acronym / sponsor ID
- 88998377LYM1001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 29 Oct 2027 (estimated)
- Study completion
- 29 Dec 2028 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Dose Escalation | Experimental | Drug: JNJ-88998377Participants 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). |
| Part B: Dose Expansion | Experimental | Drug: JNJ-88998377Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-88998377JNJ-88998377 will be administered. | Drug | Part A: Dose Escalation, Part B: Dose Expansion |
Primary outcome
Parts A and B: Number of Participants with Adverse Events (AEs)
Time frame: 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)
Time frame: 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.
7 secondary outcomes
Plasma Concentration of JNJ-88998377
Time frame: Up to first 12 weeks
Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377
Time frame: Up to first 12 weeks
Maximum Plasma Concentration (Cmax) of JNJ-88998377
Time frame: Up to first 12 weeks
Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377
Time frame: Up to first 12 weeks
Percentage of Participants With Overall Response (OR)
Time frame: Up to 3 years 4 months
Time to Response (TTR)
Time frame: From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)
Duration of Response (DOR)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
19 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-88998377 in people with Lymphoma, Non-Hodgkin and Refractory B-Cell NHL, run by Janssen Research & Development, LLC at 19 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China, Japan, Poland, Turkey (Türkiye), South Korea and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts A and B: Number of Participants with Adverse Events (AEs) (time frame: Upto 3 years 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.