Lymphoma, Non-HodgkinPhase 1NCT06660563
A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL)
A Phase 1 study testing JNJ-80948543 and JNJ-75348780 in people with Lymphoma, Non-Hodgkin, run by Janssen Research & Development, LLC at 11 sites in 4 countries.
Trial summary
The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: 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-80948543 and JNJ-75348780
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 22 Oct 2024to 31 Mar 2027
- 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 diffuse large B-cell lymphoma (DLBCL), including high-grade B-cell lymphoma and DLBCL arising from indolent lymphoma. All participants must have received at least 2 prior lines of therapy
- Participants must have measurable disease as defined by the appropriate disease response criteria
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- 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 24 hours before 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
- Prior solid-organ transplantation
- Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug
- Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade <= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2)
- Clinically significant pulmonary compromise defined as the need for supplemental oxygen to maintain adequate oxygenation
- Evidence of clinically significant and/or symptomatic infection (viral, bacterial, or fungal) at the time of study drug initiation. Anti-microbial treatment for infection must be discontinued at least 7 days before the first dose of study drug
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Spain5 sites
Hosp Univ Vall D Hebron
Barcelona, 08035
Hosp. Clinic de Barcelona
Barcelona, 08036
Inst. Cat. Doncologia-H Duran I Reynals
L'Hospitalet de Llobregat, 08908
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007
Hosp. Univ. 12 de Octubre
Madrid, 28041
Australia3 sites
Concord Hospital
Concord, 2139
St Vincents Hospital Melbourne
Fitzroy, 3065
Macquarie University Hospital
North Ryde, 2109
Taiwan2 sites
China Medical University Hospital
Taichung, 40447
National Taiwan University Hospital
Taipei, 100
United Kingdom1 site
University Hospitals Of Leicester Nhs Trust
Leicester, Le1 5ww
About this study
Official title: A Phase 1b Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers (TCEs) in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoid (R/R B-Cell NHL) Malignancies
The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: Dose Expansion).
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- 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-80948543Drug
JNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection.
JNJ-75348780Drug
JNJ-75348780 will be administered as SC injection.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-80948543 | Experimental | Participants will receive JNJ-80948543 in combination with JNJ-75348780 to determine the recommended phase 2 regimen (RP2R) in Part 1 (Dose escalation). JNJ-80948543 will be dosed in an escalation manner in combination with fixed doses of JNJ-75348780. In Part 2 (Dose expansion) participants will receive RP2R of JNJ-80948543 as determined in Part 1 in combination with JNJ-75348780. Receives: Drug: JNJ-80948543; Drug: JNJ-75348780 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-limiting Toxicity (DLT)
Number of participants with DLT will be reported. DLTs are defined as any of the treatment-related toxicities: any toxicity that would require discontinuation of treatment; Fatal toxicity; Non-hematologic toxicity (Grade 3 toxicity or higher with exceptions); and Hematologic Toxicity (Grade 4 neutrophil count decrease; Grade 4 febrile neutropenia; Grade 3 febrile neutropenia that does not recover with best supportive care within 7 days; Grade 4 platelet count decrease for >=7 days or Grade >3 with Grade >=2 bleeding; Grade 4 anemia).
Measured: Up to 1 year and 10 months
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Measured: Up to 1 year and 10 months
Secondary outcomes (8)
Serum Concentration of JNJ-80948543 and JNJ-75348780
Serum Concentration for JNJ-80948543 and JNJ-75348780 will be reported.
Measured: Up to 1 year and 10 months
Area Under the Curve (AUCtau) for JNJ-80948543 and JNJ-75348780
AUC tau is defined as area under the serum concentration-time curve during a dosing interval for JNJ-80948543 and JNJ-75348780.
Measured: Up to 1 year and 10 months
Maximum Serum Concentration (Cmax) for JNJ-80948543 and JNJ-75348780
Cmax for JNJ-80948543 and JNJ-75348780 will be reported.
Measured: Up to 1 year and 10 months
Time to Reach Cmax (Tmax) for JNJ-80948543 and JNJ-75348780
Tmax is the time to reach maximum observed serum concentration for JNJ-80948543 and JNJ-75348780.
Measured: Up to 1 year and 10 months
Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543 and JNJ-75348780
Number of participants with presence of anti-drug antibodies of JNJ-80948543 and JNJ-75348780 will be assessed.
Measured: Up to 1 year and 10 months
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who have a best response of partial response (PR) or better as assessed by the investigator based on standard response criteria.
Measured: Up to 1 year and 10 months
Complete Response Rate (CRR)
CR is defined as the percentage of participants who achieve a best response of CR as assessed by the investigator based on standard response criteria.
Measured: Up to 1 year and 10 months
Duration of Response (DoR)
DOR is defined 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 as assessed by the investigator based on standard response criteria.
Measured: Up to 1 year and 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start22 Oct 2024
- Primary completion19 Jan 2026
- Study completion31 Mar 2027 (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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT06660563
- Sponsor's protocol ID
- 80948543LYM1002
- Other IDs
- 80948543LYM1002, 2024-514176-41-00
- Status last verified
- Nov 2026
- First submitted
- 25 Oct 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 the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/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 1b Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers (TCEs) in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoid (R/R B-Cell NHL) Malignancies
- ClinicalTrials.gov ID
- NCT06660563
- Acronym / sponsor ID
- 80948543LYM1002
- Conditions
- Lymphoma, Non-Hodgkin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 19 Jan 2026 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 Oct 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 purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: Dose Expansion).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JNJ-80948543 | Experimental | Drug: JNJ-80948543, Drug: JNJ-75348780Participants will receive JNJ-80948543 in combination with JNJ-75348780 to determine the recommended phase 2 regimen (RP2R) in Part 1 (Dose escalation). JNJ-80948543 will be dosed in an escalation manner in combination with fixed doses of JNJ-75348780. In Part 2 (Dose expansion) participants will receive RP2R of JNJ-80948543 as determined in Part 1 in combination with JNJ-75348780. |
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 diffuse large B-cell lymphoma (DLBCL), including high-grade B-cell lymphoma and DLBCL arising from indolent lymphoma. All participants must have received at least 2 prior lines of therapy
- Participants must have measurable disease as defined by the appropriate disease response criteria
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- 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 24 hours before the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Key exclusion criteria (6 listed)
- Known active central nervous system involvement (CNS) or leptomeningeal involvement
- Prior solid-organ transplantation
- Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug
- Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade <= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2)
- Clinically significant pulmonary compromise defined as the need for supplemental oxygen to maintain adequate oxygenation
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-80948543JNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection. | Drug | JNJ-80948543 |
| JNJ-75348780JNJ-75348780 will be administered as SC injection. | Drug | JNJ-80948543 |
Primary outcome
Number of Participants with Dose-limiting Toxicity (DLT)
Time frame: Up to 1 year and 10 months
Number of participants with DLT will be reported. DLTs are defined as any of the treatment-related toxicities: any toxicity that would require discontinuation of treatment; Fatal toxicity; Non-hematologic toxicity (Grade 3 toxicity or higher with exceptions); and Hematologic Toxicity (Grade 4 neutrophil count decrease; Grade 4 febrile neutropenia; Grade 3 febrile neutropenia that does not recover with best supportive care within 7 days; Grade 4 platelet count decrease for >=7 days or Grade >3 with Grade >=2 bleeding; Grade 4 anemia).
Number of Participants with Adverse Events (AEs)
Time frame: Up to 1 year and 10 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
8 secondary outcomes
Serum Concentration of JNJ-80948543 and JNJ-75348780
Time frame: Up to 1 year and 10 months
Area Under the Curve (AUCtau) for JNJ-80948543 and JNJ-75348780
Time frame: Up to 1 year and 10 months
Maximum Serum Concentration (Cmax) for JNJ-80948543 and JNJ-75348780
Time frame: Up to 1 year and 10 months
Time to Reach Cmax (Tmax) for JNJ-80948543 and JNJ-75348780
Time frame: Up to 1 year and 10 months
Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543 and JNJ-75348780
Time frame: Up to 1 year and 10 months
Overall Response Rate (ORR)
Time frame: Up to 1 year and 10 months
Complete Response Rate (CRR)
Time frame: Up to 1 year and 10 months
Duration of Response (DoR)
Time frame: Up to 1 year and 10 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 the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/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
11 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-80948543 and JNJ-75348780 in people with Lymphoma, Non-Hodgkin, run by Janssen Research & Development, LLC at 11 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 6 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 11 sites in Spain, Australia, Taiwan, United Kingdom. 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?
Number of Participants with Dose-limiting Toxicity (DLT) (time frame: Up to 1 year and 10 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.