What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, particularly autologous CAR T cell therapies like JV-213, often include side effects such as cytokine release syndrome (CRS), which can cause fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and trouble breathing. Neurological toxicities are also common, presenting as confusion, difficulty speaking, and seizures. Other potential side effects include infections due to immunosuppression, cytopenias (low blood cell counts), and organ toxicities. These side effects can vary in severity and may require supportive care or additional treatments to manage.

What prior FDA approvals exist?

The FDA has approved several autologous CAR T cell therapies for the treatment of B-cell lymphomas, which are similar to the JV-213 therapy being studied. Notable approvals include axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah), both targeting CD19. These therapies are indicated for relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. Brexucabtagene autoleucel (Tecartus) is another CAR T cell therapy approved for relapsed or refractory mantle cell lymphoma. These treatments have shown significant efficacy in achieving durable remissions in patients with limited options.

What other types of research exist?

Promising alternatives to JV-213 for Non-Hodgkin's Lymphoma patients include: 1) Allogeneic hematopoietic cell transplantation (HCT) with nonmyeloablative conditioning, which has shown high survival rates and manageable chronic GVHD. 2) Bispecific T cell engagers (BiTEs) such as teclistamab and AMG 701, which target specific antigens on B-cells. 3) Anti-BCMA antibody drug conjugates like belantamab mafodotin, which have been effective in targeting B-cell maturation antigen. These therapies offer novel mechanisms of action and have demonstrated promising results in clinical trials.

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CAR T-cell Therapy

CAR T-cell Therapy for B-Cell Lymphoma

Phase 1

Recruiting

Led By Sattva Neelapu, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find the highest safe dose of JV-213, a treatment where a patient's immune cells are modified to fight cancer, for patients with B-cell lymphoma that has come back or is not responding to other treatments.

Who is the study for?

Adults with B-cell lymphomas that have come back or haven't responded to treatment can join this trial. They must be over 18, have a certain level of overall health and organ function, and at least one measurable lesion. Prior treatments should be completed with recovery from most side effects, except hair loss.

What is being tested?

The trial is testing JV-213 CAR T cell therapy to find the highest dose patients can tolerate without severe side effects. Participants will undergo leukapheresis (a procedure to collect white blood cells) before receiving the therapy.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fever, fatigue, and breathing difficulties; there may also be risks associated with leukapheresis like low blood pressure or dizziness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 2 (dose expansion)Experimental Treatment2 Interventions

Participants will receive JV-213 at the recommended dose that was found in Part 1.

Group II: Part 1 (dose escalation)Experimental Treatment2 Interventions

Part 1, the dose of JV-213 participants receive will depend on when you join this study. Up to 3 dose levels of JV-213 will be tested. About 3-6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level of JV-213. Each new group will receive a higher dose of JV-213 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of JV-213 is found.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leukapheresis

2016

Completed Phase 2

~710

Do I qualify?Apply below to find out

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 CAR T cell therapy, monoclonal antibodies, chemotherapy, and targeted therapies. CAR T cell therapy, like JV-213, involves modifying a patient's own T cells to express a chimeric antigen receptor (CAR) that specifically targets and kills B-cell lymphoma cells. Monoclonal antibodies, such as rituximab, bind to specific proteins on the surface of lymphoma cells, marking them for destruction by the immune system. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Targeted therapies, such as BTK inhibitors, interfere with specific molecules involved in cancer cell growth and survival. These treatments are crucial for NHL patients as they offer various mechanisms to attack cancer cells, potentially leading to better outcomes and personalized treatment options.