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

Completed · Phase 1

Conditions studied: Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell

In brief

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.

Key facts

Study ID

NCT04540796

Run by

Janssen Research & Development, LLC

People needed

147

Starts

2020-11-20

Expected to finish

2025-09-09

Last updated by the study team

2025-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Austin Hospital — Heidelberg, Australia
• Linear Clinical Research Ltd — Nedlands, Australia
• CHRU de Lille Hopital Claude Huriez — Lille, France
• CHU Nantes — Nantes, France
• Centre hospitalier Lyon-Sud — Pierre-Bénite, France
• Rambam Medical Center — Haifa, Israel
• Carmel Medical Center — Haifa, Israel
• Hadassah Medical Center — Jerusalem, Israel
• Sheba Medical Center — Ramat Gan, Israel
• Tel Aviv Sourasky MC — Tel Aviv, Israel
• Seoul National University Hospital — Seoul, South Korea
• Severance Hospital Yonsei University Health System — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• The Catholic University of Korea Seoul St Marys Hospital — Seoul, South Korea
• Hospital de Vall D'Hebron — Barcelona, Spain
• Hosp. Univ. Germans Trias I Pujol — Barcelona, Spain
• Hosp Univ Fund Jimenez Diaz — Madrid, Spain
• Clinica Univ. de Navarra — Pamplona, Spain
• Hosp Clinico Univ de Salamanca — Salamanca, Spain
• Chang-Gung Memorial Hospital, Kaohsiung — Kaohsiung City, Taiwan
• China Medical University Hospital — Taichung, Taiwan

Full record on ClinicalTrials.gov

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