What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, such as chemotherapy, immunotherapy, and targeted therapies, often result in side effects like neutropenia, anemia, nausea, diarrhea, fatigue, and infections. More severe side effects can include organ toxicity (hepatic or renal impairment) and an increased risk of secondary malignancies. Infusion-related reactions are also common with immunotherapy and targeted treatments.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies and targeted therapies. Rituximab, an anti-CD20 monoclonal antibody, is widely used for various B-cell NHL subtypes. Other similar agents include ofatumumab and obinutuzumab, which also target CD20. Additionally, idelalisib, a PI3K inhibitor, has been approved for relapsed/refractory cases. These treatments focus on targeting specific proteins on B-cells, similar to the investigational drug JNJ-75348780 being studied for its safety and optimal dosing in relapsed/refractory B-cell NHL.

What other types of research exist?

Promising novel alternatives for Non-Hodgkin's Lymphoma patients in 2024 include: 1) CAR T-cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which have shown significant efficacy in relapsed/refractory NHL. 2) Bispecific T-cell engagers (BiTEs) like blinatumomab, which direct T-cells to target and kill lymphoma cells. 3) Antibody-drug conjugates (ADCs) such as polatuzumab vedotin, which deliver cytotoxic agents directly to cancer cells. 4) Small molecule inhibitors like ibrutinib and venetoclax, which target specific pathways critical for lymphoma cell survival and proliferation.

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Monoclonal Antibodies

JNJ-75348780 for Lymphoma and Leukemia

Q: What is the mechanism of action of this treatment?

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies, chemotherapy, and targeted therapies. Monoclonal antibodies, such as rituximab, bind to specific antigens on lymphoma cells, triggering immune responses that lead to cell death. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Targeted therapies, like kinase inhibitors, disrupt specific molecular pathways critical for cancer cell survival and growth. These mechanisms are important for NHL patients as they allow for tailored treatment approaches that can enhance effectiveness and reduce adverse effects.

Phase 1

Waitlist Available

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 Grade of 0 or 1

Be older than 18 years old

Must not have

Either of the following: a) received an autologous stem cell transplant <=3 months before the first dose of JNJ 75348780, b) prior treatment with allogenic stem cell transplant <= 6 months before the first dose of JNJ-75348780, or has evidence of graft versus host disease that requires immunosuppressant therapy

Prior chemotherapy, targeted therapy, immunotherapy or radiotherapy (with the exclusion of palliative radiation to limited sites that do not interfere with response assessment based on a sufficient number of other sites), within 2 weeks before the first administration of study drug. For investigational agents where the half-life is known, there should be a treatment-free window of at least 2 weeks or 5 half-lives, whichever is longer. For investigational agents with long half-lives a wash-out of 4 weeks is acceptable. Participants who received prior treatment with anti-CD20 * anti-CD3 bispecific therapy will be excluded until a dedicated cohort(s) is opened as determined by the SET

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose, 48 hours postdose (up to 2 years 10 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests JNJ-75348780, a new medicine that helps the immune system fight blood cancers in patients whose cancers have returned or did not respond to other treatments. It works by connecting immune cells to cancer cells, helping the immune system attack the cancer.

Who is the study for?

This trial is for adults with B-cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia that's come back or hasn't responded to treatment. They should have tried other approved treatments without success and must not be pregnant, agree to use effective contraception, and be in good physical condition (ECOG Grade 0 or 1).

What is being tested?

The study tests JNJ-75348780's safety and optimal dose for patients with specific types of lymphomas and leukemia. Part A determines the best dose while Part B further examines its safety at this established dose.

What are the potential side effects?

While the side effects are being characterized in this study, potential risks may include typical reactions to new cancer drugs such as immune system effects, infusion-related reactions, fatigue, nausea, and blood count changes.

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.

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 recently or need immunosuppressants due to graft versus host disease.

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I haven't had cancer treatments excluding minor radiation, for at least 2 weeks or 5 half-lives of the drug, whichever is longer.

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My lymphoma has spread to my brain or spinal cord.

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I am on medication for an autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose, 48 hours postdose (up to 2 years 10 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose, 48 hours postdose (up to 2 years 10 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose, 48 hours postdose (up to 2 years 10 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part A and Part B: Number of Participants with AEs by Severity

Part A and Part B: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Part A and Part B: Number of Participants with Dose-Limiting Toxicity (DLT)

Secondary study objectives

Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-75348780

Complete Response (CR) Rate

Duration of Response (DOR)

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: Cohort ExpansionExperimental Treatment1 Intervention

Participants will receive JNJ-75348780 at one of the putative RP2Ds determined in Part A.

Group II: Part A: Dose EscalationExperimental Treatment1 Intervention

Participants will receive JNJ-75348780. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET), along with the potential exploration of other routes of administration and schedules, until one or more recommended Phase 2 Doses (RP2D) have been identified.

0 / 5Eligibility 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 Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies, chemotherapy, and targeted therapies. Monoclonal antibodies, such as rituximab, bind to specific antigens on lymphoma cells, triggering immune responses that lead to cell death. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Targeted therapies, like kinase inhibitors, disrupt specific molecular pathways critical for cancer cell survival and growth. These mechanisms are important for NHL patients as they allow for tailored treatment approaches that can enhance effectiveness and reduce adverse effects.

[Staging and Treatment Response Evaluation in Malignant Lymphomas - Czech Lymphoma Study Group Recommendations According to Criteria Revised in 2014 (Lugano Classification)].