What side effects are associated with this type of intervention?

Common treatments for Large B-Cell Lymphoma, such as chemotherapy, immunotherapy, and targeted therapies, often have a range of side effects. Chemotherapy can cause pancytopenia, infection, liver toxicity, and neuropathy. Immunotherapy, including CAR-T cell therapies like KITE-197, may lead to cytokine release syndrome (CRS), neurotoxicity, and increased risk of infections. Targeted therapies, such as those involving monoclonal antibodies, can result in infusion reactions, fatigue, and hematologic toxicities. These side effects vary in severity and frequency, and patients should discuss them with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several CAR-T cell therapies for the treatment of relapsed or refractory Large B-Cell Lymphoma (LBCL). Notably, axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) have shown significant efficacy in this patient population. These therapies involve reprogramming a patient's own T cells to target and kill cancer cells expressing the CD19 antigen. Additionally, brexucabtagene autoleucel (Tecartus) has been approved for mantle cell lymphoma, which shares some therapeutic approaches with LBCL. These CAR-T therapies have demonstrated high overall response rates and durable remissions, although they are associated with serious adverse events such as cytokine release syndrome and neurotoxicity.

What other types of research exist?

Promising novel alternatives to KITE-197 for large B-cell lymphoma patients include: 1) CAR T-cell therapies such as axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah), which have shown significant efficacy in relapsed or refractory LBCL. 2) Bispecific T-cell engagers (BiTEs) like glofitamab and epcoritamab, which target CD20 and CD3, offering a novel mechanism of action. 3) Antibody-drug conjugates (ADCs) such as polatuzumab vedotin, which targets CD79b and delivers cytotoxic agents directly to cancer cells. These therapies represent cutting-edge advancements and provide new options for patients with LBCL.

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CAR T-cell Therapy

KITE-197 for Large B-cell Lymphoma

Phase 1

Recruiting

Research Sponsored by Kite, A Gilead Company

Eligibility Criteria Checklist

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

Must have

Relapsed or Refractory Large B-cell Lymphoma

Key

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called KITE-197 for patients whose large B-cell lymphoma has returned or didn't respond to previous treatments. The study will first check if the drug is safe and find the best dose. Then, it will see if this dose can help eliminate the cancer completely. Another treatment for this type of lymphoma is available for those who have not responded to multiple previous treatments.

Who is the study for?

This trial is for individuals with relapsed or refractory Large B-cell Lymphoma who have at least one measurable lesion and proper organ and bone marrow function. It's not suitable for those who don't meet these health requirements.

What is being tested?

The study tests KITE-197, alongside Cyclophosphamide and Fludarabine, in two phases: Phase 1a focuses on safety, tolerability, and dosing; Phase 1b assesses the effectiveness of KITE-197 at the recommended dose by looking at remission rates.

What are the potential side effects?

Potential side effects may include reactions to the infusion of KITE-197, as well as impacts from Cyclophosphamide and Fludarabine such as nausea, hair loss, mouth sores, decreased blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My large B-cell lymphoma has returned or is not responding to treatment.

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It looks like there might be a mistake or missing information in your request. Could you please provide more details or clarify the criterion you'd like to have rewritten in simpler language?

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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

Phase 1b: Complete Remission (CR) Rate

Secondary study objectives

Duration of Response (DOR)

Event Free Survival (EFS)

Overall Response Rate (ORR)

+3 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: KITE-197Experimental Treatment3 Interventions

Phase 1a (Dose Escalation): Participants with r/r large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-197 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-197. Phase 1b (Dose Expansion): After completion of dose escalation, additional participants with r/r B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-197 CAR-transduced autologous T cells at 1 or more dose-level deemed to be tolerable.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2310

0 / 2Eligibility 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

Common treatments for Large B-Cell Lymphoma (LBCL) include chemotherapy, monoclonal antibodies, and CAR-T cell therapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells. Monoclonal antibodies, such as rituximab, target specific proteins on the surface of B-cells, marking them for destruction by the immune system. CAR-T cell therapy, like the investigational KITE-197, involves modifying a patient's T cells to express a chimeric antigen receptor (CAR) that specifically targets and kills B-cells. These treatments are crucial for LBCL patients as they offer targeted approaches to eliminate cancer cells, potentially leading to better outcomes and fewer side effects compared to traditional therapies.

Fundamentals of the management of non-Hodgkin lymphoma.