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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04540796
Other study ID # CR108882
Secondary ID 2020-001183-2975
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date November 20, 2020
Est. completion date May 9, 2025

Study information

Verified date June 2024
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 147
Est. completion date May 9, 2025
Est. primary completion date April 4, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Australia Austin Hospital Heidelberg
Australia Linear Clinical Research Ltd Nedlands
France CHRU de Lille Hopital Claude Huriez Lille
France CHU Nantes NANTES Cedex 1
France Centre hospitalier Lyon-Sud Pierre Benite
Israel Carmel Medical Center Haifa
Israel Rambam Medical Center Haifa
Israel Hadassah Medical Center Jerusalem
Israel Sheba Medical Center Ramat Gan
Israel Tel Aviv Sourasky MC Tel Aviv
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea Seoul St. Mary's Hospital Seoul
Spain Hosp. Univ. Germans Trias I Pujol Barcelona
Spain Hospital de Vall D'Hebron Barcelona
Spain Hosp Univ Fund Jimenez Diaz Madrid
Spain Clinica Univ. de Navarra Pamplona
Spain Hosp Clinico Univ de Salamanca Salamanca
Taiwan Chang-Gung Memorial Hospital, Kaohsiung Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
United Kingdom Leicester Royal Infirmary Leicester
United Kingdom King s College Hospital London
United Kingdom The Christie Nhs Foundation Trust Manchester
United Kingdom Plymouth Hospital NHS Trust Plymouth
United States University of Alabama at Birmingham Birmingham Alabama
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Icahn School of Medicine at Mount Sinai New York New York

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  France,  Israel,  Korea, Republic of,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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. Up to 2 years 10 months
Secondary Maximum Observed Serum Concentration (Cmax) of JNJ-75348780 Cmax is the maximum observed serum concentration of JNJ-75348780. Predose, 48 hours postdose (up to 2 years 10 months)
Secondary Minimum Observed Serum Concentration (Cmin) of JNJ-75348780 Cmin is the minimum observed serum concentration of JNJ-75348780. Predose, 48 hours postdose (up to 2 years 10 months)
Secondary 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. Up to 2 years 10 months
Secondary 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. Up to 2 years 10 months
Secondary 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. Up to 2 years 10 months
Secondary 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. Up to 2 years 10 months
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