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

  • STATUS
    Recruiting
  • End date
    May 24, 2023
  • participants needed
    120
  • sponsor
    Janssen Research & Development, LLC
Updated on 12 November 2021
chronic lymphocytic leukemia
tyrosine
lymphoma
measurable disease
cell transplantation
leukemia
follicular lymphoma
diffuse large b-cell lymphoma
b-cell lymphoma
mantle cell lymphoma
marginal zone lymphoma
beta human chorionic gonadotrophin
large b-cell lymphoma
high dose chemotherapy
anti-cd20 antibody

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 2.7 years. 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.

Details
Condition Lymphoma, Chronic Lymphocytic Leukemia, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, non-hodgkin's lymphoma (nhl)
Treatment JNJ-75348780
Clinical Study IdentifierNCT04540796
SponsorJanssen Research & Development, LLC
Last Modified on12 November 2021

Eligibility

Yes No Not Sure

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
Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1
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
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
not eligible for high-dose chemotherapy and autologous stem cell
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
transplantation with curative intent, b) If follicular lymphoma (FL)/ marginal
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
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
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

Exclusion Criteria

Known active central nervous system (CNS) involvement with lymphoma
Prior solid-organ transplantation
Active autoimmune disease that requires systemic immunosuppressive medications (example, chronic corticosteroid, methotrexate, or tacrolimus)
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
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