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Lymphoma, Non-HodgkinPhase 1NCT07308132

A Study of JNJ-95566692 in Participants With Non-Hodgkin Lymphoid Malignancies

A Phase 1 study testing JNJ-95566692, JNJ-87801493 and loncastuximab tesirine in people with Lymphoma, Non-Hodgkin, run by Janssen Research & Development, LLC at 19 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to determine the putative recommended Phase 2 doses (RP2Ds) and optimal dose schedule(s) for JNJ-95566692 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) and for JNJ-95566692 with or without JNJ-87801493 with various standard of care (SOC) regimens (Arms C-G) in Part… 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-95566692, JNJ-87801493 and loncastuximab tesirine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
19 sitesin 5 countries
Study dates
20 Jan 2026to 31 Oct 2029
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

  • B-cell non-Hodgkin lymphoid malignancies (NHL) according to World Health Organization (WHO) 2022 and no other approved therapies available that would be more appropriate in the investigator's judgment. -Histologic documentation of the following large B-cell lymphomas: -diffuse large B-cell lymphoma not otherwise specified (NOS), -T-cell/histiocyte-rich large B-cell lymphoma, -diffuse large B-cell lymphoma/high grade B-cell lymphoma with MYC and BCL2 rearrangements, -large B-cell lymphoma with IRF4 rearrangement, -high grade B-cell lymphoma with 11q aberrations, -Epstein-Barr virus (EBV)-positive diffuse large B-cell lymphoma, -diffuse large B-cell lymphoma associated with chronic inflammation, -primary large B-cell lymphoma of immune privileged sites, -primary cutaneous diffuse large B-cell lymphoma-leg type , -primary mediastinal large B-cell lymphoma, -high-grade B-cell lymphoma NOS, -transformations of indolent B-cell lymphoma (For US sites). -Other B-cell NHL may be enrolled based on emerging data in specific cohorts as stipulated by study evaluation team (SET)
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Participants must have measurable disease as defined by the disease criteria (Lugano criteria)
  • While on study treatment and for 3 months after the last dose of study treatment, a participant must: not breastfeed or become pregnant; not donate gametes (that is, eggs or sperm) or freeze for future use for the purposes of assisted reproduction; and wear an external condom; -Participants of childbearing potential must have a negative highly sensitive (for example, beta [β]-human chorionic gonadotropin) pregnancy test at screening and within 24 hours before the first dose of study treatment and agree to further pregnancy tests, -For Arm E ONLY: Practice 2 methods of reliable birth control simultaneously, including 1 highly effective form of contraception and 1 additional effective contraceptive method., -Participants on Arms C-G should also follow the pregnancy and contraception restrictions in the respective local corresponding product label

Who cannot join

  • Known active central nervous system involvement (CNS) or leptomeningeal involvement
  • Prior solid-organ transplantation
  • Malignancy diagnosis other than the disease under study within 1 year prior to the first dose of the study treatment; 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 treatment in the opinion of both the investigator and sponsor's medical monitor
  • Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (for example, methotrexate or tacrolimus) within 3 months prior to first dose of study treatment
  • Toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia, vitiligo, peripheral neuropathy, or Grade <=2 endocrinopathies that are stable on hormone replacement)

Trial locations and contacts

19 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

19 sites in 5 countries

Spain5 sites, 5 recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

    Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 8036

    Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050

    Recruiting

Other trials in Spain

Australia4 sites, 4 recruiting

  • Monash Medical Centre

    Clayton, 3168

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

    Recruiting

  • Macquarie University Hospital

    North Ryde, 2109

    Recruiting

  • Scientia Clinical Research

    Randwick, 2031

    Recruiting

Other trials in Australia

France4 sites, 4 recruiting

  • Hopital Claude Huriez

    Lille, 59000

    Recruiting

  • CHU Pitie Salpetriere

    Paris, 75013

    Recruiting

  • CHU Lyon Sud

    Pierre-Bénite, 69495

    Recruiting

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31100

    Recruiting

Other trials in France

Turkey (Türkiye)4 sites, 4 recruiting

  • SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi

    Ankara, 06200

    Recruiting

  • Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi

    Ankara, 06620

    Recruiting

  • Memorial Antalya Hastanesi Faz 1 Klinik Arastirma Merkezi

    Antalya, 07025

    Recruiting

  • Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi

    Istanbul, 34010

    Recruiting

Other trials in Turkey (Türkiye)

Belgium2 sites, 2 recruiting

  • UZ Antwerpen

    Edegem, 2650

    Recruiting

  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

    Liège, 4000

    Recruiting

Other trials in Belgium

About this study

Official title: A Phase 1, First-in-Human Study of a Novel CD79bxCD20xCD3 Trispecific Antibody in B-Cell Non-Hodgkin Lymphoid Malignancies (NHLs)

The purpose of this study is to determine the putative recommended Phase 2 doses (RP2Ds) and optimal dose schedule(s) for JNJ-95566692 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) and for JNJ-95566692 with or without JNJ-87801493 with various standard of care (SOC) regimens (Arms C-G) in Part 1: Dose Escalation part of the study. Part 2: Dose Expansion part of the study will further characterize the safety.

Being tested
JNJ-95566692, JNJ-87801493, loncastuximab tesirine, Lenalidomide, Rituximab
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-95566692Drug

    JNJ-95566692 will be administered subcutaneously.

  • JNJ-87801493Drug

    JNJ-87801493 will be administered subcutaneously.

  • loncastuximab tesirineDrug

    Loncastuximab tesirine will be administered intervenously.

  • LenalidomideDrug

    Lenalidomide will be administered orally.

  • RituximabDrug

    Rituximab will be administered intravenously and may be administered subcutaneously after the first administration.

  • GemcitabineDrug

    Gemcitabine will be administered intravenously.

  • OxaliplatinDrug

    Oxaliplatin will be administered intravenously.

  • CyclophosphamideDrug

    Cyclophosphamide will be administered intravenously.

  • DoxorubicinDrug

    Doxorubicin will be administered intravenously.

  • VincristineDrug

    Vincristine will be administered intravenously.

  • PrednisoneDrug

    Prednisone will be administered orally.

  • Polatuzumab vedotinDrug

    Polatuzumab vedotin will be administered intravenously.

Study groups in NCT07308132
Study groupRoleWhat they receive
Arm A: JNJ-95566692ExperimentalParticipants will receive escalating doses of JNJ-95566692 in Part 1 (Dose escalation) to determine the putative recommended Phase 2 doses (RP2D[s]) and dosing schedule(s). Participants in Part 2 (Dose expansion) will receive JNJ-95566692 at the putative RP2D(s) determined in Part 1 to further characterize safety, PK (pharmacokinetic), pharmacodynamic (PD) and clinical activity.
Receives: Drug: JNJ-95566692
Arm B: JNJ-95566692 in combination with JNJ-87801493ExperimentalParticipants will receive escalating doses of JNJ-95566692 in combination with JNJ-87801493 in Part 1 (Dose escalation) to determine the putative RP2D[s] and dosing schedule(s). Participants in Part 2 (Dose expansion) will receive JNJ-95566692 in combination with JNJ-87801493 at the putative RP2D(s) determined in Part 1 to further characterize safety, PK, PD and clinical activity.
Receives: Drug: JNJ-95566692; Drug: JNJ-87801493
Arm C: JNJ-95566692 and loncastuximab tesirine with or without JNJ-87801493ExperimentalParticipants will receive escalating doses for JNJ-95566692 and loncastuximab tesirine with or without JNJ-87801493 followed by the target dose in Part 1 (Dose escalation) to determine the putative RP2D[s] and dosing schedule(s). Participants in Part 2 (Dose expansion) will receive JNJ-95566692 and loncastuximab tesirine with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1.
Receives: Drug: JNJ-95566692; Drug: JNJ-87801493; Drug: loncastuximab tesirine
Arm D: JNJ-95566692 and R-GemOx with or without JNJ-87801493ExperimentalParticipants will receive escalating doses of JNJ-95566692 and R-GemOx (rituximab, gemcitabine, oxaliplatin) with or without JNJ-87801493 followed by the target dose in Part 1 (Dose escalation) to determine the putative RP2D[s] and dosing schedule(s). Participants in Part 2 (Dose expansion) will receive JNJ-95566692 and R-GemOx with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1.
Receives: Drug: JNJ-95566692; Drug: JNJ-87801493; Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin
Arm E: JNJ-95566692 and lenalidomide with or without JNJ-87801493ExperimentalParticipants will receive escalating doses of JNJ-95566692 and lenalidomide with or without JNJ-87801493 in Part 1 (Dose escalation) to determine the putative RP2D[s] and dosing schedule(s). Participants in Part 2 (Dose expansion) will receive JNJ-95566692 and lenalidomide with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1.
Receives: Drug: JNJ-95566692; Drug: JNJ-87801493; Drug: Lenalidomide
Arm F: JNJ-95566692 and R-CHOP with or without JNJ-87801493ExperimentalParticipants will receive escalating doses of JNJ-95566692 and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) with or without JNJ-87801493 followed by the target dose in Part 1 (Dose escalation) to determine the putative RP2D[s] and dosing schedule(s). Participants in Part 2 (Dose expansion) will receive JNJ-95566692 and R-CHOP with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1.
Receives: Drug: JNJ-95566692; Drug: JNJ-87801493; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone
Arm G: JNJ-95566692 and Pola-R-CHP with or without JNJ-87801493ExperimentalParticipants will receive escalating doses of JNJ-95566692 and Pola-R-CHP (polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone) with or without JNJ-87801493 followed by the target dose in Part 1 (Dose escalation) to determine the putative RP2D[s] and dosing schedule(s). Participants in Part 2 (Dose expansion) will receive JNJ-95566692 and Pola-R-CHP with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1.
Receives: Drug: JNJ-95566692; Drug: JNJ-87801493; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Polatuzumab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 and 2: Number of Participants with Adverse Events (AEs) And Serious Adverse Events (SAEs) 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: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and Grade 5 (death related to adverse event). SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

    Measured: Approximately 2 years and 8 months

  2. Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)

    Number of participants with DLTs for JNJ-95566692 (arm A), in combination with JNJ-87801493 (arm B) and in arms C to G 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: Approximately 2 years and 8 months

Secondary outcomes (15)

  1. Serum Concentration for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    Serum concentration for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be assessed using a validated assay method.

    Measured: Approximately 2 years and 8 months

  2. Area Under the Curve During a Dosing Interval (AUCtau) in JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    AUC tau is defined as area under the serum concentration-time curve during a dosing interval (tau).

    Measured: Approximately 2 years and 8 months

  3. Maximum Serum Concentration (Cmax) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    Cmax for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

    Measured: Approximately 2 years and 8 months

  4. Minimum Serum Concentration (Cmin) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    Cmin for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

    Measured: Approximately 2 years and 8 months

  5. Area Under the Curve (AUC[0-t]) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    AUC(0-t) for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

    Measured: Approximately 2 years and 8 months

  6. Half-life (t1/2) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    Half-life (t1/2) for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

    Measured: Approximately 2 years and 8 months

  7. Time to Reach Cmax (Tmax) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    Tmax is the time to reach maximum observed serum concentration for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

    Measured: Approximately 2 years and 8 months

  8. Apparent Total Body Clearance (CL/F) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    CL/F for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

    Measured: Approximately 2 years and 8 months

  9. Apparent Volume of Distribution (V/F) for JNJ-95566692 (Arms A-G) And JNJ-87801493 (Arms B-G)

    V/F for JNJ-95566692 (Arms A-G) and JNJ-87801493 (Arms B-G), where applicable will be reported.

    Measured: Approximately 2 years and 8 months

  10. Number of Participants with Anti-JNJ-95566692 Antibodies in Arms A to G

    Participants with presence of antibodies binding to JNJ-95566692 in arm A to G will be reported.

    Measured: Approximately 2 years and 8 months

  11. Number of Participants with Anti-JNJ-87801493 Antibodies in Arms B to G

    Participants with presence of antibodies binding to JNJ-87801493 in arm B to G (as appropriate) will be reported.

    Measured: Approximately 2 years and 8 months

  12. Part 2: Overall Response for JNJ-95566692 (Arm A), in Combination With JNJ-87801493 (Arm B) And for JNJ-95566692 ± JNJ-87801493 with Combination Therapies In Arms C to G

    Overall response is defined as a best response of partial response (PR) or better as assessed by the investigator according to standard response criteria per Lugano.

    Measured: Approximately 2 years and 8 months

  13. Part 2: Complete Response (CR) for JNJ-95566692 (Arm A), in Combination With JNJ-87801493 (Arm B) And for JNJ-95566692 ± JNJ-87801493 with Combination Therapies In Arms C to G

    Complete response (CR) is defined as a best response of CR as assessed by the investigator according to standard response criteria per Lugano.

    Measured: Approximately 2 years and 8 months

  14. Part 2: Time to Response (TTR) for JNJ-95566692 (Arm A), in Combination With JNJ-87801493 (Arm B) And for JNJ-95566692 ± JNJ-87801493 with Combination Therapies In Arms C to G

    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.

    Measured: Approximately 2 years and 8 months

  15. Part 2: Duration of Response (DOR) for JNJ-95566692 (Arm A), in Combination With JNJ-87801493 (Arm B) And for JNJ-95566692 ± JNJ-87801493 with Combination Therapies In Arms C to G

    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, initiation of a new systemic anti-cancer therapy or death.

    Measured: Approximately 2 years and 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2025
  2. Study start20 Jan 2026
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Oct 2029 (estimated)

Resources

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
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07308132
Sponsor's protocol ID
95566692LYM1001
Other IDs
95566692LYM1001, 2025-523297-16-00, 2025
Status last verified
Nov 2026
First submitted
15 Dec 2025
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-95566692, JNJ-87801493 and loncastuximab tesirine in people with Lymphoma, Non-Hodgkin, run by Janssen Research & Development, LLC at 19 sites in 5 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 4 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: looking for participants now, 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 Spain, Australia, France, Turkey (Türkiye), Belgium. 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?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 and 2: Number of Participants with Adverse Events (AEs) And Serious Adverse Events (SAEs) by Severity (time frame: Approximately 2 years and 8 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 NCT07308132.

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.

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