What side effects are associated with this type of intervention?

Common treatments for B-Cell Non-Hodgkin Lymphoma include chemotherapy, monoclonal antibodies, and CAR T-cell therapies. For treatments similar to JNJ-90014496, such as CAR T-cell therapies targeting CD19 and CD20, known side effects include cytokine release syndrome (CRS), which can cause fever, nausea, headache, hypotension, and increased liver enzymes. Neurologic toxicities, such as encephalopathy, seizures, and confusion, are also common. Other potential side effects include infections due to immunosuppression, cytopenias (low blood cell counts), and infusion reactions.

What prior FDA approvals exist?

The FDA has approved several CAR T-cell therapies for the treatment of B-Cell Non-Hodgkin Lymphoma. Notably, axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) are CAR T-cell therapies targeting CD19, which have shown significant efficacy in relapsed or refractory B-NHL. Additionally, monoclonal antibodies such as rituximab, ofatumumab, and obinutuzumab, which target CD20, have been widely used in the treatment of B-NHL. These therapies have paved the way for the development of more advanced treatments like the bi-specific CAR T-cell therapy targeting both CD19 and CD20, as investigated in the JNJ-90014496 trial.

What other types of research exist?

Promising alternatives to JNJ-90014496 for B-Cell Non-Hodgkin Lymphoma include: 1) Rituximab, an anti-CD20 monoclonal antibody, which has shown improved results when combined with chemotherapy. 2) Inotuzumab ozogamicin, an anti-CD22 immunotoxin, with high complete remission rates in relapsed/refractory patients. 3) Blinatumomab, a bispecific anti-CD19 and anti-CD3 agent, approved for relapsed/refractory patients with a 40% complete remission rate. These therapies offer different mechanisms of action and have demonstrated efficacy in clinical settings.

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CAR T-cell Therapy

CAR-T Therapy for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Led By John Baird, M.D.

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive

Must not have

Autologous stem cell transplant within 12 weeks of chimeric antigen receptor (CAR) T cell infusion

Diagnosis of Human herpes virus (HHV) 8-positive diffuse large B Cell lymphoma (DLBCL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the first 12 months follow up period completion (3 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment where a patient's own immune cells are modified to better attack their cancer. It is for adults with a type of lymphoma that hasn't responded to other treatments. The modified cells target specific proteins on the cancer cells to help the immune system destroy them. This new method enhances the patient's immune cells to find and eliminate cancer cells.

Who is the study for?

Adults with B-Cell non-Hodgkin lymphoma that has come back or didn't respond after at least two standard treatments can join. They must be over 18, have a certain level of physical fitness (ECOG status 0 or 1), and their major organs need to function well. People with recent serious blood clots, active severe infections, other cancers within the last five years (except some skin or in situ cancers), pregnant women, and those with certain heart conditions cannot participate.

What is being tested?

The trial is testing JNJ-90014496, an experimental CAR T-cell therapy targeting CD19 and CD20 proteins on cancer cells. It's for adults whose aggressive B-cell non-Hodgkin lymphoma hasn't been cured by previous treatments. This Phase Ib study is open-label, meaning everyone knows they're getting the test treatment.

What are the potential side effects?

Potential side effects may include immune system reactions causing inflammation in various body parts, infusion-related symptoms like fever or chills, fatigue, digestive issues such as nausea or diarrhea, blood cell count changes increasing infection risk; specific side effect profiles will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My tumor is confirmed to be CD19 or CD20 positive.

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I am 18 years old or older.

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I have been diagnosed with a type of aggressive large B cell lymphoma or follicular lymphoma.

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My disease has come back or hasn't responded to treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stem cell transplant less than 12 weeks before my CAR T cell treatment.

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I have been diagnosed with a specific type of lymphoma linked to the HHV-8 virus.

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I do not have any untreated or uncontrolled infections.

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I have had optic neuritis or another immune-related disease affecting my brain or spinal cord.

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I have had a stem cell transplant from a donor.

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I have an active liver or biliary disease.

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I have a history of seizures or brain-related health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the first 12 months follow up period completion (3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the first 12 months follow up period completion (3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the first 12 months follow up period completion (3 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determination of the Recommended Phase 2 Dose (RP2D) of JNJ-90014496 in Participants with Relapsed or Refractory B-cell non-Hodgkin lymphoma (B-NHL)

Occurrence of Adverse Events (AEs) [Safety and Tolerability]

Secondary study objectives

Duration of Response (DOR)

Overall Response (OR)

Pharmacokinetic Evaluation of JNJ-90014496

+1 more

Other study objectives

Anti-drug (C-CAR039) antibody

Blood cytokines changes

Overall survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: JNJ-90014496Experimental Treatment1 Intervention

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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for B-Cell Non-Hodgkin Lymphoma (B-NHL) include chemotherapy, monoclonal antibodies, and CAR T-cell therapies. Chemotherapy works by killing rapidly dividing cells, including cancer cells. Monoclonal antibodies, such as rituximab, target specific proteins on the surface of B-cells, leading to their destruction. CAR T-cell therapies, like JNJ-90014496, involve modifying a patient's own T-cells to express chimeric antigen receptors (CARs) that specifically target CD19 and CD20 proteins on B-cells. This dual targeting enhances the ability to recognize and kill cancerous B-cells. These mechanisms are crucial for B-NHL patients as they provide targeted and effective treatment options, potentially leading to better outcomes and fewer side effects compared to traditional therapies.