A Study of JNJ-75348780 in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
A Study of JNJ-75348780 in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (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.
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.
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: 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 at least 1
 prior line of systemic therapy 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 1 prior line of systemic therapy containing a bruton tyrosine kinase inhibitor (BTKi)
 and 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 active 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

 -  Active autoimmune disease that requires systemic immunosuppressive medications
 (example, chronic corticosteroid, methotrexate, or tacrolimus)