Lymphoma, Non-HodgkinPhase 1NCT05424822
A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
A Phase 1 study testing JNJ-80948543 in people with Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell, run by Janssen Research & Development, LLC at 29 sites in 8 countries.
Trial summary
The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]), optimal dosing schedule(s) and route(s) of administration of JNJ-80948543 in Part A (Dose Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
- What is being tested?
- JNJ-80948543
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 29 sitesin 8 countries
- Study dates
- 18 Aug 2022to 30 Jul 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 disease: B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) requiring therapy.
- All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment.
- B-cell NHL as defined per the 2016 world health organization (WHO) classification. In addition, the following disease-specific criteria outlined below must be met:
- If diffuse large B-cell lymphoma (DLBCL) or other high-Grade B-cell lymphoma: Received, or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent or deemed not eligible or fit for an alternative 2nd line therapy. Participants may be eligible if relapsing after chimeric antigen receptors (CAR-T) cell treatment or while waiting for a CAR-T cell treatment.
- If transformed lymphoma from low Grade B-cell malignancies: Received or not a candidate for an approved first-line regimen for DLBCL and received or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent.
- If follicular lymphoma (FL) (all grades): Previously treated with a minimum of 2 prior lines of systemic therapy, with at least one prior line containing an anti-CD20 antibody.
Show all 13Show fewer
- If mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) (including nodal, extranodal/MALT, and splenic MZL subtypes): Previously treated with at least 2 lines of systemic therapy. H.pylori-positive gastric MALT lymphoma must have failed prior H. pylori eradication therapy as one of their prior lines .
- Waldenstrom macroglobulinemia (WM): Previously treated with at least 1 line of systemic therapy.
- small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL/SLL): Relapsed or refractory with at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor (BTK) inhibitor or a BCL2 inhibitor, if eligible. In addition for part B Participants must have measurable disease as defined by the appropriate disease response criteria
- Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1
- Cardiac parameters within the following range: corrected QT interval (QTc intervals corrected using Fridericia's formula [QTcF]) less than or equal to (<=) 480 milliseconds based on the average of triplicate assessments performed no more than 5 (plus minus [+-] 3) minutes apart
- A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta- human chorionic gonadotropin) at screening and must agree to further serum or urine pregnancy tests prior to the first dose, during the study and until 3 months after the last dose of study treatment
- A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study treatment
Who cannot join
- Known active central nervous system (CNS) involvement; Lymphoma with CNS involvement may be allowed in pharmacokinetic/ pharmacodynamic (PK/PD) and expansion cohorts if approved by the study evaluation team (SET)
- 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, particularly the need for supplemental oxygen use to maintain adequate oxygenation
Trial locations and contacts
29 sites in 8 countries.
29 sites in 8 countries
United States7 sites
City of Hope
Duarte, California, 91010
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Texas Transplant Institute
San Antonio, Texas, 78229
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Australia4 sites
Macquarie University Hospital
Macquarie University, 2109
The Alfred Hospital
Melbourne, 3004
Linear Clinical Research Ltd
Nedlands, 6009
Scientia Clinical Research
Randwick, 2031
China4 sites
Chongqing University Cancer Hospital
Chongqing, 400044
Sun Yat Sen University Cancer Center
Guangzhou, 510060
Tianjin cancer hospital
Tianjin, 300060
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030
France4 sites
CHRU de Lille Hopital Claude Huriez
Lille, 59037
Institut Curie
Paris, 75005
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, 67033
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse, 31059
Israel3 sites
Carmel Medical Center
Haifa, 34362
Hadassah Medical Center
Jerusalem, 9112001
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Japan3 sites
National Cancer Center Hospital East
Kashiwa, 277 8577
Aichi Cancer Center
Nagoya, 464 8681
The Cancer Institute Hospital of JFCR
Tokyo, 135 8550
Denmark2 sites
Rigshospitalet
Copenhagen, 2100
Odense University Hospital
Odense, 5000
Poland2 sites
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
Gdansk, 80 214
Aidport Sp z o o
Skorzewo, 60-185
About this study
Official title: A Phase 1, First-in-human Study of JNJ-80948543, a T-cell Redirecting Antibody, in Participants With NHL and CLL
The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]), optimal dosing schedule(s) and route(s) of administration of JNJ-80948543 in Part A (Dose Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort Expansion).
- Being tested
- JNJ-80948543
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
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 SC or IV injection.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose Escalation | Experimental | Participants will receive JNJ-80948543 either by subcutaneous (SC) or intravenous (IV) administration to determine the putative recommended Phase 2 dose (RP2D) dosing schedule(s) and route(s) of administration based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens. Receives: Drug: JNJ-80948543 |
| Part B: Cohort Expansion | Experimental | Participants will receive JNJ-80948543 by SC or IV administration. Receives: Drug: JNJ-80948543 |
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. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Measured: Up to 4 Years 3 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 4 Years 3 months
Number of Participants with AE by Severity
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 4 (Life-threatening). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded as per American Society for Transplantation and Cellular Therapy (ASTCT).
Measured: Up to 4 Years 3 months
Secondary outcomes (7)
Serum Concentration of JNJ-80948543
Serum samples will be analyzed to determine concentrations of JNJ-80948543 using a validated, specific, and sensitive method.
Measured: Up to 4 Years 3 months
Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543
Number of participants with presence of anti-drug antibodies of JNJ-80948543 will be assessed.
Measured: Up to 4 Years 3 months
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who have a best response of partial response (PR) or better.
Measured: Up to 4 Years 3 months
Complete Response (CR) Rate
CR rate is defined as the percentage of participants who achieve a best response of CR.
Measured: Up to 4 Years 3 months
Rate of VGPR or Better for Participants with Waldenstrom Macroglobulinemia (WM)
The response criteria planned to be used for participants with WM includes a category of VGPR, which is clinically understood to be better than PR but not as good as CR. For participants with WM, this rate is defined as the proportion of participants who achieve a best response of VGPR or better.
Measured: Up to 4 Years 3 months
Time to Response (TTR)
TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR.
Measured: Up to 4 Years 3 months
Duration of Response (DOR)
DOR is defined for participants who achieved a response of PR or better as the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death.
Measured: Up to 4 Years 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start18 Aug 2022
- Primary completion31 Oct 2025
- Study completion30 Jul 2027 (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
- 167 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
- NCT05424822
- Sponsor's protocol ID
- CR109174
- Other IDs
- 2022-000685-18, 80948543LYM1001, 2023-504187-42-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 15 Jun 2022
- Last updated
- 28 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 the Janssen Pharmaceutical Companies of Johnson \& 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
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 28 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-80948543, a T-cell Redirecting Antibody, in Participants With NHL and CLL
- ClinicalTrials.gov ID
- NCT05424822
- Acronym / sponsor ID
- CR109174
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 21 Jun 2022 (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 putative recommended Phase 2 dose(s) (RP2D[s]), optimal dosing schedule(s) and route(s) of administration of JNJ-80948543 in Part A (Dose Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort Expansion).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Dose Escalation | Experimental | Drug: JNJ-80948543Participants will receive JNJ-80948543 either by subcutaneous (SC) or intravenous (IV) administration to determine the putative recommended Phase 2 dose (RP2D) dosing schedule(s) and route(s) of administration based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens. |
| Part B: Cohort Expansion | Experimental | Drug: JNJ-80948543Participants will receive JNJ-80948543 by SC or IV administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologic documentation of disease: B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) requiring therapy.
- All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment.
- B-cell NHL as defined per the 2016 world health organization (WHO) classification. In addition, the following disease-specific criteria outlined below must be met:
- If diffuse large B-cell lymphoma (DLBCL) or other high-Grade B-cell lymphoma: Received, or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent or deemed not eligible or fit for an alternative 2nd line therapy. Participants may be eligible if relapsing after chimeric antigen receptors (CAR-T) cell treatment or while waiting for a CAR-T cell treatment.
- If transformed lymphoma from low Grade B-cell malignancies: Received or not a candidate for an approved first-line regimen for DLBCL and received or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent.
Key exclusion criteria (5 listed)
- Known active central nervous system (CNS) involvement; Lymphoma with CNS involvement may be allowed in pharmacokinetic/ pharmacodynamic (PK/PD) and expansion cohorts if approved by the study evaluation team (SET)
- 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, particularly the need for supplemental oxygen use 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 SC or IV injection. | Drug | Part A: Dose Escalation, Part B: Cohort Expansion |
Primary outcome
Number of Participants with Dose-limiting Toxicity (DLT)
Time frame: Up to 4 Years 3 months
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Number of Participants with Adverse Events (AEs)
Time frame: Up to 4 Years 3 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.
Number of Participants with AE by Severity
Time frame: Up to 4 Years 3 months
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 4 (Life-threatening). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded as per American Society for Transplantation and Cellular Therapy (ASTCT).
7 secondary outcomes
Serum Concentration of JNJ-80948543
Time frame: Up to 4 Years 3 months
Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543
Time frame: Up to 4 Years 3 months
Overall Response Rate (ORR)
Time frame: Up to 4 Years 3 months
Complete Response (CR) Rate
Time frame: Up to 4 Years 3 months
Rate of VGPR or Better for Participants with Waldenstrom Macroglobulinemia (WM)
Time frame: Up to 4 Years 3 months
Time to Response (TTR)
Time frame: Up to 4 Years 3 months
Duration of Response (DOR)
Time frame: Up to 4 Years 3 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 28 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 the Janssen Pharmaceutical Companies of Johnson \& 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
29 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-80948543 in people with Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell, run by Janssen Research & Development, LLC at 29 sites in 8 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 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 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 29 sites in United States, Australia, China, France, Israel and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-limiting Toxicity (DLT) (time frame: Up to 4 Years 3 months). The study lists 3 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 NCT05424822, 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 28 Sep 2026.