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

NCT04540796 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR10888275348780LYM10012020-001183-29
• Study Type: interventional
• Target: 147
• Locations: 8 countries
• Sites: 32

Brief 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 the safety at the RP2D(s) in Part B.

Conditions

Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 2 years 10 months

• 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.

  Up to 2 years 10 months

• 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.

  Up to 28 days

Secondary Outcomes (7)

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

  Up to 2 years 10 months

• Maximum Observed Serum Concentration (Cmax) of JNJ-75348780

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

• Minimum Observed Serum Concentration (Cmin) of JNJ-75348780

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

• Objective Response Rate (ORR)

  Up to 2 years 10 months

• Complete Response (CR) Rate

  Up to 2 years 10 months

Study Arms (2)

Part A: Dose Escalation

EXPERIMENTAL

Participants 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.

Drug: JNJ-75348780

Part B: Cohort Expansion

EXPERIMENTAL

Participants will receive JNJ-75348780 at one of the putative RP2Ds determined in Part A.

Drug: JNJ-75348780

Interventions

JNJ-75348780 DRUG

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

Part A: Dose Escalation; Part B: Cohort Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (32)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Austin Hospital

Heidelberg, 3084, Australia

Location

Linear Clinical Research Ltd

Nedlands, 6009, Australia

Location

CHRU de Lille Hopital Claude Huriez

Lille, 59037, France

Location

CHU Nantes

Nantes, 44093, France

Location

Centre hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Carmel Medical Center

Haifa, 34362, Israel

Location

Hadassah Medical Center

Jerusalem, 9112001, Israel

Location

Sheba Medical Center

Ramat Gan, 74047, Israel

Location

Tel Aviv Sourasky MC

Tel Aviv, 6423906, Israel

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea

Location

Hospital de Vall D'Hebron

Barcelona, 08035, Spain

Location

Hosp. Univ. Germans Trias I Pujol

Barcelona, 8916, Spain

Location

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Chang-Gung Memorial Hospital, Kaohsiung

Kaohsiung City, 83301, Taiwan

Location

China Medical University Hospital

Taichung, 40402, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

The Christie Nhs Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Plymouth Hospital NHS Trust

Plymouth, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 7, 2020
• Study Start: November 20, 2020
• Primary Completion: September 9, 2025
• Study Completion: September 9, 2025
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (4); AU (2); FR (3); ES (5); TW (5); US (3); IL (5); KR (5)