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

Browse trials for

• Lymphoma, Non-Hodgkin 1,989
• Lymphoma, B-Cell 1,411
• Lymphoma, Large B-Cell, Diffuse 1,390

Keywords

• CD20/CD19

Lymphoma, Non-Hodgkin

1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.

This study's enrollment of 166 is above the median of 41 across 1,703 interventional studies indexed under Lymphoma, Non-Hodgkin.

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Study arms

• Experimental
  JNJ-90014496

  Participants will receive intravenous (IV) infusion of autologous JNJ-90014496. The study is no longer enrolling.

  Biological: JNJ-90014496

Interventions

• BiologicalJNJ-90014496

  JNJ-90014496, an autologous dual targeting chimeric antigen receptor (CAR) - T cell therapy targeting Cluster of differentiation (CD)20 and CD19.

Primary outcomes

1. Phase 1b: Occurrence of Adverse Events (AEs) [Safety and Tolerability]

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

   Time frame: Up to 15 Years post JNJ-90014496 infusion

2. Phase 2: Overall Response (OR) As Assessed by Independent Review Committee (IRC)

   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).

   Time frame: Up to 6 months post last participant's JNJ-90014496 infusion

Secondary outcomes

1. Phase 1b: Overall Response (OR)

   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).

   Time frame: Up to 6 months post last participant's JNJ-90014496 infusion

2. Phase 1b: Duration of Response (DOR)

   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).

   Time frame: Up to 6 months post last participant's JNJ-90014496 infusion

3. Phase 1b: Pharmacokinetic Evaluation of JNJ-90014496

   JNJ-90014496 blood levels will be reported.

   Time frame: Up to 6 months post last participant's JNJ-90014496 infusion

4. Phase 2: Occurrence of Adverse Events (AEs) by Severity

   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.

   Time frame: Up to 15 Years post JNJ-90014496 infusion

5. Phase 2: Complete Response (CR)

   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.

   Time frame: Up to 6 months post last participant's JNJ-90014496 infusion

6. Phase 2: Duration of Response (DOR)

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

   Time frame: Up to 6 months post last participant's JNJ-90014496 infusion

7. Phase 2: Progression Free Survival (PFS)

   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.

   Time frame: Up to 6 months post last participant's JNJ-90014496 infusion

8. Phase 2: Overall Survival (OS)

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

   Time frame: Up to 15 Years post JNJ-90014496 infusion

9. Phase 2: Maximum Observed Blood Concentration (Cmax) for JNJ-90014496

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

   Time frame: Up to 6 months post last participant's JNJ-90014496 infusion

10. Phase 2: Time to Reach Maximum Observed Cmax (Tmax) for JNJ-90014496

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

    Time frame: Up to 6 months post last participant's JNJ-90014496 infusion

11. Phase 2: Area Under the Blood Concentration Time Curve (AUC) for JNJ-90014496

    AUC for JNJ-90014496 will be reported.

    Time frame: Up to 6 months post last participant's JNJ-90014496 infusion

12. Change From Baseline of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Symptom Score

    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.

    Time frame: From Baseline Up to 6 months post JNJ-90014496 infusion

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.