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Lymphoma, Non-HodgkinPhase 1NCT04540796

A Study of JNJ-75348780 in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

A Phase 1 study testing JNJ-75348780 in people with Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell, run by Janssen Research & Development, LLC at 32 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]) and optimal dosing schedule(s) of JNJ-75348780 in participants with relapsed/ refractory B-cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) in Part A and to further characterize… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JNJ-75348780
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
32 sitesin 8 countries
Study dates
20 Nov 2020to 9 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 NHL or 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 a) If diffuse large B-cell lymphoma (DLBCL): received, or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent, b) If follicular lymphoma (FL)/ marginal zone lymphoma (MZL) (except mucosa-associated lymphoid tissue [MALT]), or Waldenstrom macroglobulinemia (WM): previously treated with a minimum of 2 prior lines of systemic therapy, with at least 1 prior line containing an anti-CD20 antibody, c) If mantle cell lymphoma (MCL): previously treated with at least 1 prior line of systemic therapy containing an anti-CD20 antibody. CLL or small lymphocytic lymphoma (SLL): relapsed or refractory with at least 2 prior lines of therapy to include a bruton tyrosine kinase inhibitor (BTKi) and/or a B-cell lymphoma (BCL)2 inhibitor, if eligible. 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 (ms) based on the average of triplicate assessments performed no more than 5 (plus minus [+ -] 3) minutes apart
  • Women of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta human chorionic gonadotropin) at screening and prior to the first dose of study drug
  • Women must be: a) not of childbearing potential, b) of childbearing potential and practicing a highly effective, preferably user independent method of contraception (failure rate of less than (<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study drug and until 90 days after last dose

Who cannot join

  • Known central nervous system (CNS) involvement with lymphoma
  • Prior solid-organ transplantation
  • Either of the following: a) received an autologous stem cell transplant <=3 months before the first dose of JNJ 75348780, b) prior treatment with allogenic stem cell transplant <= 6 months before the first dose of JNJ-75348780, or has evidence of graft versus host disease that requires immunosuppressant therapy
  • Prior chemotherapy, targeted therapy, immunotherapy or radiotherapy (with the exclusion of palliative radiation to limited sites that do not interfere with response assessment based on a sufficient number of other sites), within 2 weeks before the first administration of study drug. 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, whichever is longer. For investigational agents with long half-lives a wash-out of 4 weeks is acceptable. Participants who received prior treatment with anti-CD20 * anti-CD3 bispecific therapy will be excluded until a dedicated cohort(s) is opened as determined by the SET
  • Active autoimmune disease that requires systemic immunosuppressive medications (example, chronic corticosteroid, methotrexate, or tacrolimus)
  • History of malignancy (other than the disease under study in the cohort to which the participant is assigned) within 1 year prior to the first administration of study drug. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy which in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 1 year before the first dose of study drug. Concomitant malignancies that are unlikely to progress and/or preclude evaluation of study endpoints may be allowed after discussion with the Study Responsible Physician

Trial locations and contacts

32 sites in 8 countries.

32 sites in 8 countries

Israel5 sites

  • Rambam Medical Center

    Haifa, 31096

  • Carmel Medical Center

    Haifa, 34362

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Sheba Medical Center

    Ramat Gan, 74047

  • Tel Aviv Sourasky MC

    Tel Aviv, 6423906

Other trials in Israel

South Korea5 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Spain5 sites

  • Hospital de Vall D'Hebron

    Barcelona, 08035

  • Hosp. Univ. Germans Trias I Pujol

    Barcelona, 8916

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

Other trials in Spain

Taiwan5 sites

  • Chang-Gung Memorial Hospital, Kaohsiung

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, 40402

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10048

Other trials in Taiwan

United Kingdom4 sites

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Kings College Hospital

    London, SE5 9RS

  • The Christie Nhs Foundation Trust

    Manchester, M20 4BX

  • Plymouth Hospital NHS Trust

    Plymouth, PL6 8DH

Other trials in United Kingdom

United States3 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

France3 sites

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59037

  • CHU Nantes

    Nantes, 44093

  • Centre hospitalier Lyon-Sud

    Pierre-Bénite, 69495

Other trials in France

Australia2 sites

  • Austin Hospital

    Heidelberg, 3084

  • Linear Clinical Research Ltd

    Nedlands, 6009

Other trials in Australia

About this study

Official title: A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 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]) and optimal dosing schedule(s) of JNJ-75348780 in participants with relapsed/ refractory B-cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) in Part A and to further characterize the safety at the RP2D(s) in Part B.

Read the detailed description

B-cell lymphoid malignancies include CLL and NHL and are defined by clonal populations of B-lymphocytes expressing identical surface antigens. CD22 is a surface protein specifically expressed on B-lymphocytes and is expressed in B-lymphocytic malignancies. It is known to negatively regulate the B-cell receptor via its cytosolic immunoreceptor tyrosine-based inhibitory motifs. JNJ-75348780 is a novel human bispecific antibody that recognizes the CD3 antigen on T-lymphocytes and the CD22 antigen on mature and malignant B-lymphocytes. JNJ-75348780 is hypothesized to lead to cytotoxicity, T-cell activation, and induction of cytokines upon engagement of CD3 on T-cells and CD22 on malignant B-lymphocytes. The study consists of screening phase, treatment phase and post-treatment phase. The total study duration will be up to 2 years 10 months. Efficacy assessments will include radiographic image assessments, positron emission tomography scan, bone marrow assessment, endoscopy or colonoscopy, physical examinations. Safety will be monitored throughout the study.

Being tested
JNJ-75348780
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-75348780Drug

    Participants will receive JNJ-75348780 by subcutaneous (SC) administration.

Study groups in NCT04540796
Study groupRoleWhat they receive
Part A: Dose EscalationExperimentalParticipants will receive JNJ-75348780. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET), along with the potential exploration of other routes of administration and schedules, until one or more recommended Phase 2 Doses (RP2D) have been identified.
Receives: Drug: JNJ-75348780
Part B: Cohort ExpansionExperimentalParticipants will receive JNJ-75348780 at one of the putative RP2Ds determined in Part A.
Receives: Drug: JNJ-75348780

What is being measured

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

  1. Part A and Part B: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Measured: Up to 2 years 10 months

  2. Part A and Part B: Number of Participants with AEs by Severity

    Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

    Measured: Up to 2 years 10 months

  3. Part A and Part B: Number of Participants with Dose-Limiting Toxicity (DLT)

    Number of participants with DLT will be assessed. 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 28 days

Secondary outcomes (7)

  1. Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-75348780

    AUCtau is the measure of the serum drug concentration from time zero to end of dosing interval.

    Measured: Up to 2 years 10 months

  2. Maximum Observed Serum Concentration (Cmax) of JNJ-75348780

    Cmax is the maximum observed serum concentration of JNJ-75348780.

    Measured: Predose, 48 hours postdose (up to 2 years 10 months)

  3. Minimum Observed Serum Concentration (Cmin) of JNJ-75348780

    Cmin is the minimum observed serum concentration of JNJ-75348780.

    Measured: Predose, 48 hours postdose (up to 2 years 10 months)

  4. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants who achieve a partial response (PR) or better according to the revised response criteria for malignant lymphoma, the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) response criteria and International Workshop for Waldenstrom Macroglobulinemia (IWWM) response criteria.

    Measured: Up to 2 years 10 months

  5. Complete Response (CR) Rate

    CR rate is defined as the percentage of participants who achieve a best response of CR according to the revised response criteria for malignant lymphoma, iwCLL response criteria and IWWM response criteria.

    Measured: Up to 2 years 10 months

  6. 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 according to the revised response criteria for malignant lymphoma, iwCLL response criteria and IWWM response criteria.

    Measured: Up to 2 years 10 months

  7. Duration of Response (DOR)

    DOR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of either the first documented evidence of disease progression or death according to the revised response criteria for malignant lymphoma, iwCLL response criteria and IWWM response criteria.

    Measured: Up to 2 years 10 months

Timeline

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

  1. First posted7 Sep 2020
  2. Study start20 Nov 2020
  3. Primary completion9 Sep 2025
  4. Study completion9 Sep 2025

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
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04540796
Sponsor's protocol ID
CR108882
Other IDs
75348780LYM1001, 2020-001183-29
Status last verified
Oct 2025
First submitted
2 Sep 2020
Last updated
10 Oct 2025
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/clinicaltrials/ 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-75348780 in people with Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell, run by Janssen Research & Development, LLC at 32 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 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: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Israel, South Korea, Spain, Taiwan, United Kingdom 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 A and Part B: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (time frame: Up to 2 years 10 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 NCT04540796.

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 10 Oct 2025.

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