A Study of JNJ-95566692 in Participants With Non-Hodgkin Lymphoid Malignancies

ConditionLymphoma, Non-Hodgkin

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorJanssen Research & Development, LLC

About this trial

The purpose of this study is to determine the putative recommended Phase 2 doses (RP2Ds) and optimal dose schedule(s) for JNJ-95566692 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) (Part 1: Dose Escalation) and to further characterize the safety and clinical activity of JNJ-95566692 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) at the putative RP2D(s) (Part 2: Dose Expansion).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

B-cell non-Hodgkin lymphoid malignancies (NHL) according to World Health Organization (WHO) 2022 with relapsed or refractory disease and no other approved therapies available that would be more appropriate in the investigator's judgment. • Participants must have received at least 2 prior lines of therapy including an αCD20 monoclonal antibody containing chemotherapy combination schedule. • Participants who have received at least one prior line of therapy but are not eligible or do not have access to standard second line therapies, such as CAR-T, will be allowed to enroll

While on study treatment and for 3 months after the last dose of study treatment, a participant must: not breastfeed or become pregnant; not donate gametes (that is, eggs or sperm) or freeze for future use for the purposes of assisted reproduction; and wear an external condom

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Participants must have measurable disease as defined by the disease criteria (Lugano criteria)

Disqualifiers

Known active central nervous system involvement (CNS) or leptomeningeal involvement

Prior solid-organ transplantation

Malignancy diagnosis other than the disease under study within 1 year prior to the first dose of the study treatment; exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of the study treatment in the opinion of both the investigator and sponsor's medical monitor

Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (for example, methotrexate or tacrolimus) within 3 months prior to first dose of study treatment

Trial design

Design model

Sequential

Treatments tested in this trial

JNJ-95566692
Drug
JNJ-95566692 will be administered subcutaneously.
JNJ-87801493
Drug
JNJ-87801493 will be administered subcutaneously.

Treatment groups

130 Participants

are divided into 2 treatment groups

Group A: Arm A: JNJ-95566692Experimental treatment 1 intervention

Group B: Arm B: JNJ-95566692 in combination with JNJ-87801493Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

Part 1 and 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B)

An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity for AEs will be specified as per: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and Grade 5 (death related to adverse event). SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

Time frame