← Back to Search

CAR T-cell Therapy

A2B694 CAR T-Cells for Solid Cancers (EVEREST-2 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by A2 Biotherapeutics Inc.

Eligibility Criteria Checklist

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

Must have

Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, OVCA, MESO, or other solid tumors with MSLN expression. Measurable disease is required with lesions of >1.0 cm by CT.

Received previous required therapy for the appropriate solid tumor disease as described in the protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of informed consent until 24 months (2 years) post a2b694 infusion

Awards & highlights

EVEREST-2 Trial Summary

This trial is testing A2B694 CAR T-cells to see if they can safely and effectively fight solid tumors such as colorectal, pancreatic, lung, ovarian and mesothelioma cancer.

Who is the study for?

This trial is for adults with certain advanced solid tumors like colorectal, lung, pancreatic, ovarian cancer or mesothelioma. These cancers must express a protein called MSLN and lack HLA-A*02 due to mutation. Participants need measurable disease over 1 cm by CT scan, good organ function, an ECOG status of 0-1 (fully active to restricted in physically strenuous activity), and a life expectancy over 3 months.Check my eligibility

What is being tested?

The study tests A2B694 CAR T-cell therapy after patients undergo preconditioning lymphodepletion. Phase 1 determines the safe dosage while Phase 2 checks if this dose effectively targets tumor cells without harming healthy ones. Patients previously enrolled in BASECAMP-1 are given A2B694 at the determined safe dose.See study design

What are the potential side effects?

Potential side effects may include immune reactions leading to inflammation in various organs (like lungs), infusion-related reactions from the CAR T-cells themselves such as fever or chills, fatigue from treatment-induced anemia or other blood cell changes, and increased risk of infections.

EVEREST-2 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer is advanced, cannot be surgically removed, and shows MSLN.

Select...

I have completed the necessary treatment for my solid tumor as outlined.

Select...

I can carry out all my daily activities without help.

EVEREST-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of informed consent until 24 months (2 years) post a2b694 infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of informed consent until 24 months (2 years) post a2b694 infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of informed consent until 24 months (2 years) post a2b694 infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: Rate of adverse events and dose limiting toxicities (DLTs) by dose level

Phase 1: Recommended Phase 2 Dose (RP2D)

Phase 2: The Overall Response Rate (ORR) for patients

Secondary outcome measures

Cytokine analysis

Persistence of A2B694

EVEREST-2 Trial Design

1Treatment groups

Experimental Treatment

Group I: A2B694Experimental Treatment2 Interventions

Patients receive Preconditioning Lymphodepletion (PCLD) Regimen followed by a single dose of A2B694 intravenously on day 0

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

A2 Biotherapeutics Inc.Lead Sponsor

2 Previous Clinical Trials

360 Total Patients Enrolled

Tempus AIIndustry Sponsor

16 Previous Clinical Trials

17,309 Total Patients Enrolled

Tempus LabsIndustry Sponsor

16 Previous Clinical Trials

17,809 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what geographic areas is this research endeavor taking place?

"This clinical trial has 10 sites across the nation, such as UCSD Moores Cancer Center in La Jolla, UCLA Medical Center in Los Angeles, and Stanford University in Stanford."

Answered by AI

Is enrollment still available for this experiment?

"Clinicaltrials.gov communicates that this trial is not presently seeking new patients for enrollment; the posting was first made on March 1st 2024 and last amended on September 21st 2023. Nevertheless, there are 7111 other medical studies still recruiting participants at present."

Answered by AI