The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for
JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further
assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2:
Dose Expansion).

A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL)

Lymphoma, Non-Hodgkin

Lymphoma, B-Cell

Lymphoma, Mantle-Cell

Mantle Cell Lymphoma

Lymphoma

Blood Cancer

Hematologic Neoplasms

Hematologic Malignancies

Hematology

Hematological Malignancies

JNJ-80948543

JNJ-75348780

A Phase 1b Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers (TCEs) in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoid (R/R B-Cell NHL) Malignancies

Number of participants with DLT will be reported. DLTs are defined as any of the
treatment-related toxicities: any toxicity that would require discontinuation of
treatment; Fatal toxicity; Non-hematologic toxicity (Grade 3 toxicity or higher with
exceptions); and Hematologic Toxicity (Grade 4 neutrophil count decrease; Grade 4 febrile
neutropenia; Grade 3 febrile neutropenia that does not recover with best supportive care
within 7 days; Grade 4 platelet count decrease for >=7 days or Grade >3 with Grade >=2
bleeding; Grade 4 anemia).

An AE is any untoward medical occurrence in a clinical study participant administered a
pharmaceutical (investigational or non-investigational) product. An AE does not
necessarily have a causal relationship with the intervention.

Serum Concentration for JNJ-80948543 and JNJ-75348780 will be reported.

AUC tau is defined as area under the serum concentration-time curve during a dosing
interval for JNJ-80948543 and JNJ-75348780.

Cmax for JNJ-80948543 and JNJ-75348780 will be reported.

Tmax is the time to reach maximum observed serum concentration for JNJ-80948543 and
JNJ-75348780.

Number of participants with presence of anti-drug antibodies of JNJ-80948543 and
JNJ-75348780 will be assessed.

ORR is defined as the percentage of participants who have a best response of partial
response (PR) or better as assessed by the investigator based on standard response
criteria.

CR is defined as the percentage of participants who achieve a best response of CR as
assessed by the investigator based on standard response criteria.

DOR is defined as the time from the first efficacy evaluation at which the participant
meet all criteria for a response of PR or better to the date of first documented evidence
of progressive disease or death as assessed by the investigator based on standard
response criteria.

Participants will receive JNJ-80948543 in combination with JNJ-75348780 to determine the
recommended phase 2 regimen (RP2R) in Part 1 (Dose escalation). JNJ-80948543 will be
dosed in an escalation manner in combination with fixed doses of JNJ-75348780. In Part 2
(Dose expansion) participants will receive RP2R of JNJ-80948543 as determined in Part 1
in combination with JNJ-75348780.

A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL)

Trials at a glance

Trials at a glance

A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL)

Outcome measures

Primary outcome measures

Secondary outcome measures