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CAR T-cell Therapy

A2B530 CAR T Therapy for Solid Cancers (EVEREST-1 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

ECOG performance status of 0 to 1

Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, or other solid tumors associated with CEA expression. Measurable disease is required with lesions of >1.0 cm by computed tomography (CT). (Soluble CEA is not acceptable as the sole measure of disease).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of informed consent until 24 months (2 years) post a2b530 infusion.

Awards & highlights

EVEREST-1 Trial Summary

This trial will test a new therapy, A2B530, on different types of solid tumors. Participants will receive treatments and assessments.

Who is the study for?

This trial is for adults with certain solid tumors like colorectal, pancreatic, or non-small cell lung cancer that express CEA and lack HLA-A*02. They must have a life expectancy of at least 3 months, be able to follow the study plan including long-term safety checks, and have completed necessary prior treatments. Pregnant or breastfeeding individuals are excluded as well as those not using birth control.Check my eligibility

What is being tested?

The study tests A2B530 CAR T-cells in patients with specific solid tumors. It's divided into two phases: Phase 1 determines the safest dose; Phase 2 checks if this dose effectively targets tumor cells while sparing healthy ones. Participants will undergo a preconditioning regimen before receiving the A2B530 treatment.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation against cancer cells which can affect normal tissues leading to symptoms such as fever, fatigue, nausea, and potential organ inflammation.

EVEREST-1 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I can carry out all my daily activities without help.

Select...

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

EVEREST-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of informed consent until 24 months (2 years) post a2b530 infusion.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of informed consent until 24 months (2 years) post a2b530 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 a2b530 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 A2B530

EVEREST-1 Trial Design

1Treatment groups

Experimental Treatment

Group I: A2530Experimental Treatment2 Interventions

Patients receive Preconditioning Lymphodepletion (PCLD) Regimen followed by a single dose of A2B530 intravenously on day 0

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

A2 Biotherapeutics Inc.Lead Sponsor

2 Previous Clinical Trials

430 Total Patients Enrolled

Tempus AIIndustry Sponsor

16 Previous Clinical Trials

17,379 Total Patients Enrolled

Tempus LabsIndustry Sponsor

16 Previous Clinical Trials

17,879 Total Patients Enrolled

Media Library

A2B530 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05736731 — Phase 1 & 2

Colorectal Cancer Research Study Groups: A2530

Colorectal Cancer Clinical Trial 2023: A2B530 Highlights & Side Effects. Trial Name: NCT05736731 — Phase 1 & 2

A2B530 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05736731 — Phase 1 & 2

Frequently Asked Questions

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

Are there any American locations in which this trial is currently being conducted?

"Currently, 7 different cities are hosting this trial. These locations include Los Angeles, Jacksonville and Tampa in addition to 4 other locales; it is recommended that study participants select the nearest site for their convenience."

Answered by AI

Are there any vacancies still available for participants in this research?

"As evidenced by the clinicaltrials.gov listing, this medical investigation is not currently recruiting participants - a status which was verified on February 10th 2023. Despite that, there are 7154 other trials actively seeking subjects at present."

Answered by AI