What side effects are associated with this type of intervention?

Common treatments for Renal Cell Carcinoma (RCC) include targeted therapies, immunotherapies, and cell-based therapies. Targeted therapies, such as tyrosine kinase inhibitors (e.g., sunitinib, axitinib), often cause side effects like hypertension, fatigue, and hand-foot syndrome. Immunotherapies, including checkpoint inhibitors (e.g., nivolumab, pembrolizumab), can lead to immune-related adverse events such as colitis, pneumonitis, and thyroid dysfunction. For cell-based therapies like CAR-T cell therapy, potential side effects include cytokine release syndrome (CRS), neurotoxicity, and increased risk of infections. These side effects are critical considerations in the management and treatment planning for RCC patients.

What prior FDA approvals exist?

The FDA has approved several treatments for Renal Cell Carcinoma (RCC), including targeted therapies and immunotherapies. Notable approvals include nivolumab (Opdivo), an anti-PD-1 therapy, and pembrolizumab (Keytruda), another anti-PD-1 therapy, both of which enhance the immune system's ability to fight cancer. Additionally, combination therapies such as pembrolizumab with axitinib (Inlyta) and nivolumab with ipilimumab (Yervoy) have been approved for advanced RCC. These treatments are similar to the investigational ALLO-316, which is an allogeneic CAR-T cell therapy targeting specific antigens on RCC cells, representing a novel approach in the immunotherapy landscape.

What other types of research exist?

Promising alternatives to ALLO-316 for Renal Cell Carcinoma patients include: 1) Pembrolizumab, an immune checkpoint inhibitor, which has shown efficacy in metastatic RCC, particularly in combination with other agents like axitinib. 2) Atezolizumab plus bevacizumab, which has demonstrated a trend towards improved overall survival in advanced RCC. 3) Nonmyeloablative allogeneic hematopoietic stem cell transplantation, which is being investigated for its potential in advanced cytokine-refractory renal cancer.

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CAR T-cell Therapy

ALLO-316 for Kidney Cancer (TRAVERSE Trial)

Phase 1

Recruiting

Research Sponsored by Allogene Therapeutics

Eligibility Criteria Checklist

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

Must have

Histologically confirmed renal cell carcinoma with a predominant clear cell component

Must have received a checkpoint inhibitor and a VEGF inhibitor in the advanced and/or metastatic setting

Must not have

Clinically significant CNS dysfunction

Prior treatment with anti-CD70 therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called ALLO-316 in adults with advanced kidney cancer. The goal is to see if ALLO-316 is safe and effective in attacking cancer cells.

Who is the study for?

This trial is for adults with advanced kidney cancer (clear cell renal cell carcinoma) who have already tried certain other cancer treatments. Participants need to be relatively healthy and active, without serious brain metastases or CNS issues, no recent anti-CD70 or anti-CD52 therapies, and no other cancers in the last 3 years.

What is being tested?

The TRAVERSE study is testing ALLO-316's safety and effectiveness after a treatment that reduces immune cells (lymphodepletion) using Fludarabine, Cyclophosphamide, and ALLO-647. It's an early-phase trial to find the right dose for Phase 2.

What are the potential side effects?

Possible side effects include reactions related to immune system suppression from lymphodepletion drugs like Fludarabine and Cyclophosphamide such as infections, low blood counts; also potential infusion-related reactions from ALLO-316.

Eligibility Criteria

Inclusion Criteria

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

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My kidney cancer is mainly made up of clear cells.

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I have been treated with drugs targeting the immune system and blood vessel growth for my advanced cancer.

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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 have a significant brain or nerve condition affecting my daily life.

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I have previously been treated with anti-CD70 therapies.

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I have not had any other cancer in the last 3 years.

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

1Treatment groups

Experimental Treatment

Group I: ALLO-647, ALLO-316Experimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1830

Cyclophosphamide

2010

Completed Phase 4

~2310

0 / 6Eligibility 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 Renal Cell Carcinoma (RCC) include immune checkpoint inhibitors, tyrosine kinase inhibitors, and CAR-T cell therapy. Immune checkpoint inhibitors, such as PD-1 and PD-L1 inhibitors, work by blocking proteins that prevent the immune system from attacking cancer cells, thereby enhancing the body's immune response against the tumor. Tyrosine kinase inhibitors, like sunitinib and axitinib, inhibit enzymes that promote cancer cell growth and angiogenesis. CAR-T cell therapy, including the allogeneic CAR-T cells studied in the ALLO-316 trial, involves genetically modifying T cells to target specific antigens on RCC cells, leading to direct tumor cell destruction. These treatments are crucial for RCC patients as they offer targeted approaches that can improve outcomes and potentially reduce side effects compared to traditional therapies.

[Immunotherapy of metastatic renal cell cancer].Potential Application of Chimeric Antigen Receptor (CAR)-T Cell Therapy in Renal Cell Tumors.Intrinsic immune alterations in renal cell carcinoma and emerging immunotherapeutic approaches.