ClinicalTrials.gg
RecruitingNCT07308132Updated Nov 3, 2026

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

A Phase 1 interventional study of JNJ-95566692 and JNJ-87801493 in Lymphoma, Non-Hodgkin, sponsored by Janssen Research & Development, LLC. Recruiting at 19 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.

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Phase
Phase 1
Study type
Interventional
Enrollment
340
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 17 studies in Lymphoma, Non-Hodgkin by Johnson & Johnson — 2 open to participants now, 7 under way, none of them phase 3. Lymphoma, Non-Hodgkin · Johnson & Johnson.

Planned enrollment
Largest of 15
340 · median 85
Started
2026
the only one that year
Phase 1
13 of 17
2 open now
Registered
17th of 17
by date

Among the 17 studies in Lymphoma, Non-Hodgkin by Johnson & Johnson, this one has the largest planned enrollment of the 15 interventional ones that give a count, is the only one that started in 2026, is one of 13 in phase 1, and was the 17th registered.

Lymphoma, Non-Hodgkin

2,287 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 286 are open to participants now.

Browse Lymphoma, Non-Hodgkin studies →

Open to participants now

2 of the 17 studies in Lymphoma, Non-Hodgkin by Johnson & Johnson are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Who these studies take

Of the 245 Lymphoma, Non-Hodgkin studies recruiting now, 145 (59%) set no upper age limit and 77 (31%) stop at 75 or younger; 68 take children under 18; 10 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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 1: Dose Escalation part of the study. Part 2: Dose Expansion part of the study will further characterize the safety.

03

Conditions studied

  • Lymphoma, Non-Hodgkin
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • B-cell non-Hodgkin lymphoid (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 (ECOG) performance status of 0 to 1
  • Participants must have 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 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 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

Exclusion criteria

Exclusion Criteria:

  • Known active central nervous system involvement (CNS) or
  • Prior solid-organ transplantation
  • 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
  • or inflammatory disease requiring systemic or other 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)
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
340 participants (estimated)

Study arms

  • Experimental
    Arm A: JNJ-95566692

    Participants 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.

    Drug: JNJ-95566692

  • Experimental
    Arm B: JNJ-95566692 in combination with JNJ-87801493

    Participants 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.

    Drug: JNJ-95566692 · Drug: JNJ-87801493

  • Experimental
    Arm C: JNJ-95566692 and loncastuximab tesirine with or without JNJ-87801493

    Participants 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.

    Drug: JNJ-95566692 · Drug: JNJ-87801493 · Drug: loncastuximab tesirine

  • Experimental
    Arm D: JNJ-95566692 and R-GemOx with or without JNJ-87801493

    Participants 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.

    Drug: JNJ-95566692 · Drug: JNJ-87801493 · Drug: Rituximab · Drug: Gemcitabine · Drug: Oxaliplatin

  • Experimental
    Arm E: JNJ-95566692 and lenalidomide with or without JNJ-87801493

    Participants 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.

    Drug: JNJ-95566692 · Drug: JNJ-87801493 · Drug: Lenalidomide

  • Experimental
    Arm F: JNJ-95566692 and R-CHOP with or without JNJ-87801493

    Participants 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.

    Drug: JNJ-95566692 · Drug: JNJ-87801493 · Drug: Rituximab · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Vincristine · Drug: Prednisone

  • Experimental
    Arm G: JNJ-95566692 and Pola-R-CHP with or without JNJ-87801493

    Participants 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.

    Drug: JNJ-95566692 · Drug: JNJ-87801493 · Drug: Rituximab · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Prednisone · Drug: Polatuzumab vedotin

Interventions

  • DrugJNJ-95566692

    JNJ-95566692 will be administered subcutaneously.

  • DrugJNJ-87801493

    JNJ-87801493 will be administered subcutaneously.

  • Loncastuximab tesirine will be administered intervenously.

  • Lenalidomide will be administered orally.

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

  • Gemcitabine will be administered intravenously.

  • Oxaliplatin will be administered intravenously.

  • Cyclophosphamide will be administered intravenously.

  • Doxorubicin will be administered intravenously.

  • Vincristine will be administered intravenously.

  • Prednisone will be administered orally.

  • Polatuzumab vedotin will be administered intravenously.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Approximately 2 years and 8 months

Secondary outcomes

  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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Approximately 2 years and 8 months

07

Study locations

19 of 19 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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

Data sharing details ↗ · innovativemedicine.jnj.com

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Aug 2028, 31 months after the start.

Of 163 industry-sponsored phase 1 interventional studies under Lymphoma, Non-Hodgkin, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's planned 31 months is below that.

Counting every sponsor, half of 286 studies reached it within 55 months; a quarter within 38 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2025
First posted
Dec 29, 2025
StartActual
Jan 20, 2026
Primary completionEst.
Aug 31, 2028
CompletionEst.
Oct 31, 2029
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07308132
Responsible party
Sponsor
First posted
Dec 29, 2025
Start date
Jan 20, 2026
Primary completion
Aug 31, 2028 (estimated)
Completion
Oct 31, 2029 (estimated)
Last update
Nov 3, 2026

Study contacts

Study Contact
Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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