This is a Phase 1b/2, multicenter, open-label, study of JNJ-90014496, an autologous
bi-specific chimeric antigen receptor (CAR) T-cell therapy targeting both cluster of
differentiation (CD) CD19 and CD20, for the treatment of adult participants with relapsed
or refractory (r/r) B-Cell non-Hodgkin lymphoma (B-NHL) or frontline high-risk diffuse
large B-cell lymphoma (DLBCL).

A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma

Lymphoma, Non-Hodgkin

Lymphoma, B-Cell

Lymphoma, Mantle-Cell

Mantle Cell Lymphoma

Lymphoma

Blood Cancer

Hematologic Neoplasms

Hematologic Malignancies

Hematology

Hematological Malignancies

Lymphoma, Large B-Cell, Diffuse

JNJ-90014496

A Phase 1b/2, Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants With B-cell Non-Hodgkin Lymphoma

Occurrence of any AEs, including dose limiting toxicities (DLTs).

Overall response is defined as a PR or CR at any point between the time of JNJ-90014496
infusion until PD or start of subsequent anti-lymphoma therapy, whichever occurs first
(per Lugano 2014 guidelines).

DOR is defined as the time from the first documented CR or PR after JNJ-90014496 infusion
until PD or death, whichever occurs first (per Lugano 2014 guidelines).

JNJ-90014496 blood levels will be reported.

Severity of AEs will be graded according to the National Cancer Institute Common
Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 as follows: Grade 1
(Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening ), Grade 5
(Death). Cytokine release syndrome (CRS), Immune effector cell-associated neurotoxicity
syndrome (ICANS), and Immune effector cell-associated hemophagocytic
lymphohistiocytosis-like syndrome (IEC-HS) will be graded according to the American
Society for Transplantation and Cellular Therapy (ASTCT) consensus grading.

A CR is defined as at any point between the date of JNJ 90014496 infusion until PD or
start of subsequent anti-lymphoma therapy, whichever occurs first.

DOR is defined as the time from the first documented CR or PR after JNJ-90014496 infusion
to relapse or death, whichever occurs first.

PFS is defined as the time from the date of JNJ-90014496 infusion to the date of first
documented disease progression, or death due to any cause, whichever occurs first.

OS is defined as the time from the date of JNJ-90014496 infusion to the date of death due
to any cause.

Blood samples will be analyzed to report Cmax for JNJ-90014496.

Blood samples will be analyzed to report Tmax for JNJ-90014496.

The FACT-Lym was developed for adult patients with lymphoma. The FACT Lym is
self-administered, with a recall period for all items being the past 7 days. Responses
are rated on a 5-point Likert response scale ranging from 0 "not at all" to 4 "very
much". Higher scores indicate fewer symptoms and better well-being.

Participants will receive intravenous (IV) infusion of autologous JNJ-90014496 on Day 1.

This is a Phase Ib multicenter, open-label study of JNJ-90014496, an autologous bi-specific
      chimeric antigen receptor (CAR) T-cell therapy, targeting both cluster of differentiation
      (CD) CD19 and CD20 for the treatment of adult participants with relapsed or refractory B-Cell
      non-Hodgkin lymphoma (r/r B-NHL).

A Study of JNJ-90014496 in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

City of Hope

A Phase Ib Multicenter, Open-Label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Incidence of any AEs, including dose limiting toxicities (DLTs).

Based on the assessment of DLTs rates and overall safety profile.

Complete response (CR) rate and partial response (PR) rate.

The time from the date of JNJ-90014496 infusion to the first documented CR or PR.

The time from the first documented CR or PR to relapse or death, whichever occurs first.

A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma

Trials at a glance

Trials at a glance

A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma

Outcome measures

Primary outcome measures

Secondary outcome measures