Lymphoma, Non-HodgkinPhase 1NCT06139406
A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer
A Phase 1 study testing JNJ-87801493, JNJ-80948543 and JNJ-75348780 in people with Lymphoma, Non-Hodgkin, run by Janssen Research & Development, LLC at 12 sites in 4 countries.
Trial summary
The purpose of this study is to characterize safety and to determine the recommended phase 2 regimen (RP2R) for JNJ-87801493 in combination with T-cell engagers (TCEs) [Part A: Dose Escalation] and to further assess the safety of JNJ-87801493 at the RP2R in combination with TCEs [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
- What is being tested?
- JNJ-87801493, JNJ-80948543 and JNJ-75348780
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 6 Dec 2023to 30 Sep 2026
- 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
- Histologic documentation of B-cell NHL. All participants in part 1 must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment. In Part 2, participants with diffuse large B-cell lymphoma (DLBCL) or other high-grade B cell lymphoma and participants with transformed lymphoma from low-grade B cell malignancies who relapsed or failed to respond to only one prior systemic treatment regimen can be included
- Part 1 participants must have evaluable or measurable disease and Part 2 participants must have measurable disease; all as defined by the Lugano criteria for non-Hodgkin lymphoid malignancies (NHL) and the international workshop on Waldenstrom's Macroglobulinemia (IWWM-6) for WM
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Hematologic laboratory parameters must meet the required criterias and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of study drug
- Participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (β)-human chorionic gonadotropin) at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
Who cannot join
- Known active central nervous system involvement (CNS) or leptomeningeal involvement. CNS involvement may be allowed in specific cohorts as determined by the Study Evaluation Team (SET)
- Prior solid-organ transplantation
- Prior treatment with JNJ-80948543 and/or JNJ-75348780. In addition, history of known allergies, hypersensitivity, or intolerance to either JNJ-80948543, JNJ-75348780, or JNJ-87801493 or its excipients
- Chemotherapy, targeted therapy, or immunotherapy within 2 weeks before the first dose of study treatment. For investigational agents where the half-life is known, there should be a treatment-free window of at least 2 weeks or 5 half-lives. For checkpoint blockade therapy (example, anti-programmed cell death protein-1 [anti-PD-1]), a washout period of up to 6 weeks may be considered
- Malignancy diagnosis other than the disease under study within 1 year prior to screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of the study drugs in the opinion of both the investigator and sponsor's medical monitor
- Autoimmune or inflammatory disease requiring systemic corticosteroids or other immunosuppressive agents within 1 year prior to first dose of study treatment
- Evidence of active viral, bacterial, or uncontrolled systemic fungal infection requiring systemic treatment within 7 days before the first dose of study treatment
- Abnormal cardiac function
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Australia4 sites
Austin Hospital
Heidelberg, 3084
The Alfred Hospital
Melbourne, 3004
Linear Clinical Research Ltd
Nedlands, 6009
Scientia Clinical Research
Randwick, 2031
Spain4 sites
Hosp Univ Vall D Hebron
Barcelona, 08035
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
Clinica Univ. de Navarra
Pamplona, 31008
Hosp Clinico Univ de Salamanca
Salamanca, 37007
Denmark2 sites
Rigshospitalet
Copenhagen, DK-2100
Odense University Hospital
Odense, 5000
Israel2 sites
Hadassah Medical Center
Jerusalem, 9112001
Sourasky (Ichilov) Medical Center
Tel Aviv, 6423906
About this study
Official title: A Phase 1, First-in-human Study of JNJ-87801493 in Combination With CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies (NHLs)
The purpose of this study is to characterize safety and to determine the recommended phase 2 regimen (RP2R) for JNJ-87801493 in combination with T-cell engagers (TCEs) [Part A: Dose Escalation] and to further assess the safety of JNJ-87801493 at the RP2R in combination with TCEs [Part B: Dose Expansion].
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- JNJ-87801493, JNJ-80948543, JNJ-75348780
- 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-87801493Drug
JNJ-87801493 will be administered subcutaneously.
JNJ-80948543Drug
JNJ-80948543 will be administered subcutaneously.
JNJ-75348780Drug
JNJ-75348780 will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose escalation | Experimental | Participants will receive one cycle of TCE monotherapy (step up dosing) with either JNJ-80948543 or JNJ-75348780 followed by initiation of combination therapy with JNJ-87801493 at least one week later. Receives: Drug: JNJ-87801493; Drug: JNJ-80948543; Drug: JNJ-75348780 |
| Part 2:Dose expansion | Experimental | Participants with specific B-cell NHL histologies will receive recommended phase 2 regimen (RP2R) of JNJ-87801493 with TCE as determined in Part 1. Receives: Drug: JNJ-87801493; Drug: JNJ-80948543; Drug: JNJ-75348780 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
Number of participants with DLTs will be reported. The DLTs are drug-related toxicities and are defined as any of the following: fatal toxicity, high grade non-hematologic toxicity, or hematologic toxicity
Measured: Up to 2 years 7 months
Part 1 and 2: Percentage of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity for AEs will be specified as per: NCI-CTCAE grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and; American Society for Transplantation and Cellular Therapy (ASTCT) guidelines which is Grade 5 (death related to adverse event); Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events [ICANS]).
Measured: Up to 2 years 7 months
Secondary outcomes (15)
Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
Measured: Up to 2 years 7 months
Area Under the Curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
AUC tau is defined as area under the serum concentration-time curve during a dosing interval (tau).Area under the serum concentration curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
Measured: Up to 2 years 7 months
Maximum Serum Concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Maximum observed serum concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
Measured: Up to 2 years 7 months
Minimum Serum Concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Minimum observed serum concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
Measured: Up to 2 years 7 months
Area Under the Curve (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Area under the curve from time zero to t (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
Measured: Up to 2 years 7 months
Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
Measured: Up to 2 years 7 months
Time to Reach Cmax (Tmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Tmax is the time to reach maximum observed serum concentartion for JNJ-87801493, JNJ-80948543 and JNJ-75348780.
Measured: Up to 2 years 7 months
Apparent Total Body Clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Apparent total body clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
Measured: Up to 2 years 7 months
Apparent Volume of Distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Apparent volume of distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780 will be reported.
Measured: Up to 2 years 7 months
Number of Participants with Presence of Anti-JNJ-87801493, Anti-JNJ- 80948543 and Anti-JNJ-75348780 Antibodies
Number of participants with presence of antibodies binding to JNJ-87801493 or each combination partner (JNJ- 80948543 and JNJ-75348780).
Measured: Up to 2 years 7 months
Overall Response as Assessed by the Investigator
Overall response is defined as a best response of partial response (PR) or better.
Measured: Up to 2 years 7 months
Complete Response (CR) as Assessed by the Investigator
Complete response (CR) is defined as a best response of CR.
Measured: Up to 2 years 7 months
Very Good Partial Response (VGPR) or better for Waldenström Macroglobulinemia (WM) Participants as Assessed by the Investigator
Very good partial response (VGPR) or better is defined as a best response of VGPR or better.
Measured: Up to 2 years 7 months
Time to Response (TTR) as Assessed by the Investigator
Time to response (TTR) is defined for participants who achieve a response of PR or better as the time from the first dose of any study drug to the first response of PR or better.
Measured: Up to 2 years 7 months
Duration of Response (DOR) as Assessed by the Investigator
Duration of response (DOR) is defined for participants who achieved a response of PR or better as the time from the first efficacy evaluation at which the participant meet all criteria for a response of PR or better to the date of first documented evidence of progressive disease or death.
Measured: Up to 2 years 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start6 Dec 2023
- Primary completion30 Jan 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 70 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
- NCT06139406
- Sponsor's protocol ID
- 87801493LYM1001
- Other IDs
- 87801493LYM1001, 2023-505165-93-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 15 Nov 2023
- Last updated
- 25 Sep 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
Publications
Kuchnio A, Yang D, Vloemans N, Cornelissen I, Amorim R, Perova T, Lowenstein C, Janssen L, Suls T, Bekkers M, Lasorsa E, Fontan L, Nemani N, Hojnacki T, Han C, Sukumaran S, Medeiros N, Srinivasan S, Wu B, Chen J, Feldkamp MD, Wu S, Habte H, McRee AJ, Daskalakis N, Krayer J, Holland C, Attar R, DeYoung PM, Singh S, Elsayed Y, Philippar U. Characterization of JNJ-80948543 a novel CD79bxCD20xCD3 trispecific antibody for B-cell non-Hodgkin lymphoma. Haematologica. 2026 Feb 26. doi: 10.3324/haematol.2025.288473. Online ahead of print.
PubMed 41742895
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-human Study of JNJ-87801493 in Combination With CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies (NHLs)
- ClinicalTrials.gov ID
- NCT06139406
- Acronym / sponsor ID
- 87801493LYM1001
- Conditions
- Lymphoma, Non-Hodgkin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 18 Nov 2023 (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 purpose of this study is to characterize safety and to determine the recommended phase 2 regimen (RP2R) for JNJ-87801493 in combination with T-cell engagers (TCEs) [Part A: Dose Escalation] and to further assess the safety of JNJ-87801493 at the RP2R in combination with TCEs [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 1: Dose escalation | Experimental | Drug: JNJ-87801493, Drug: JNJ-80948543, Drug: JNJ-75348780Participants will receive one cycle of TCE monotherapy (step up dosing) with either JNJ-80948543 or JNJ-75348780 followed by initiation of combination therapy with JNJ-87801493 at least one week later. |
| Part 2:Dose expansion | Experimental | Drug: JNJ-87801493, Drug: JNJ-80948543, Drug: JNJ-75348780Participants with specific B-cell NHL histologies will receive recommended phase 2 regimen (RP2R) of JNJ-87801493 with TCE as determined in Part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologic documentation of B-cell NHL. All participants in part 1 must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment. In Part 2, participants with diffuse large B-cell lymphoma (DLBCL) or other high-grade B cell lymphoma and participants with transformed lymphoma from low-grade B cell malignancies who relapsed or failed to respond to only one prior systemic treatment regimen can be included
- Part 1 participants must have evaluable or measurable disease and Part 2 participants must have measurable disease; all as defined by the Lugano criteria for non-Hodgkin lymphoid malignancies (NHL) and the international workshop on Waldenstrom's Macroglobulinemia (IWWM-6) for WM
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Hematologic laboratory parameters must meet the required criterias and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of study drug
- Participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (β)-human chorionic gonadotropin) at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
Key exclusion criteria (8 listed)
- Known active central nervous system involvement (CNS) or leptomeningeal involvement. CNS involvement may be allowed in specific cohorts as determined by the Study Evaluation Team (SET)
- Prior solid-organ transplantation
- Prior treatment with JNJ-80948543 and/or JNJ-75348780. In addition, history of known allergies, hypersensitivity, or intolerance to either JNJ-80948543, JNJ-75348780, or JNJ-87801493 or its excipients
- Chemotherapy, targeted therapy, or immunotherapy within 2 weeks before the first dose of study treatment. For investigational agents where the half-life is known, there should be a treatment-free window of at least 2 weeks or 5 half-lives. For checkpoint blockade therapy (example, anti-programmed cell death protein-1 [anti-PD-1]), a washout period of up to 6 weeks may be considered
- Malignancy diagnosis other than the disease under study within 1 year prior to screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of the study drugs in the opinion of both the investigator and sponsor's medical monitor
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-87801493JNJ-87801493 will be administered subcutaneously. | Drug | Part 1: Dose escalation, Part 2:Dose expansion |
| JNJ-80948543JNJ-80948543 will be administered subcutaneously. | Drug | Part 1: Dose escalation, Part 2:Dose expansion |
| JNJ-75348780JNJ-75348780 will be administered subcutaneously. | Drug | Part 1: Dose escalation, Part 2:Dose expansion |
Primary outcome
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
Time frame: Up to 2 years 7 months
Number of participants with DLTs will be reported. The DLTs are drug-related toxicities and are defined as any of the following: fatal toxicity, high grade non-hematologic toxicity, or hematologic toxicity
Part 1 and 2: Percentage of Participants with Adverse Events (AEs) by Severity
Time frame: Up to 2 years 7 months
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity for AEs will be specified as per: NCI-CTCAE grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and; American Society for Transplantation and Cellular Therapy (ASTCT) guidelines which is Grade 5 (death related to adverse event); Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events [ICANS]).
15 secondary outcomes
Serum Concentration for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Time frame: Up to 2 years 7 months
Area Under the Curve (AUCtau) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Time frame: Up to 2 years 7 months
Maximum Serum Concentration (Cmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Time frame: Up to 2 years 7 months
Minimum Serum Concentration (Cmin) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Time frame: Up to 2 years 7 months
Area Under the Curve (AUC[0-t]) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Time frame: Up to 2 years 7 months
Half-life (t1/2) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Time frame: Up to 2 years 7 months
Time to Reach Cmax (Tmax) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Time frame: Up to 2 years 7 months
Apparent Total Body Clearance (CL/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Time frame: Up to 2 years 7 months
Apparent Volume of Distribution (V/F) for JNJ-87801493, JNJ-80948543 and JNJ-75348780
Time frame: Up to 2 years 7 months
Number of Participants with Presence of Anti-JNJ-87801493, Anti-JNJ- 80948543 and Anti-JNJ-75348780 Antibodies
Time frame: Up to 2 years 7 months
Overall Response as Assessed by the Investigator
Time frame: Up to 2 years 7 months
Complete Response (CR) as Assessed by the Investigator
Time frame: Up to 2 years 7 months
Very Good Partial Response (VGPR) or better for Waldenström Macroglobulinemia (WM) Participants as Assessed by the Investigator
Time frame: Up to 2 years 7 months
Time to Response (TTR) as Assessed by the Investigator
Time frame: Up to 2 years 7 months
Duration of Response (DOR) as Assessed by the Investigator
Time frame: Up to 2 years 7 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 25 Sep 2026.
- Derived from this study: PubMed 41742895Kuchnio A, Yang D, Vloemans N, Cornelissen I, Amorim R, Perova T, Lowenstein C, Janssen L, Suls T, Bekkers M, Lasorsa E, Fontan L, Nemani N, Hojnacki T, Han C, Sukumaran S, Medeiros N, Srinivasan S, Wu B, Chen J, Feldkamp MD, Wu S, Habte H, McRee AJ, Daskalakis N, Krayer J, Holland C, Attar R, DeYoung PM, Singh S, Elsayed Y, Philippar U. Characterization of JNJ-80948543 a novel CD79bxCD20xCD3 trispecific antibody for B-cell non-Hodgkin lymphoma. Haematologica. 2026 Feb 26. doi: 10.3324/haematol.2025.288473. Online ahead of print.
- 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
Related trials for Lymphoma, Non-Hodgkin
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
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
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-87801493, JNJ-80948543 and JNJ-75348780 in people with Lymphoma, Non-Hodgkin, run by Janssen Research & Development, LLC at 12 sites in 4 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 8 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia, Spain, Denmark, Israel. 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?
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) (time frame: Up to 2 years 7 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?
On the ClinicalTrials.gov record for NCT06139406, which also lists 1 linked publication.
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 25 Sep 2026.