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CAR T-cell Therapy

AB-2100 for Recurrence

Phase 1 & 2

Recruiting

Research Sponsored by Arsenal Biosciences, Inc.

Eligibility Criteria Checklist

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

Must have

Advanced or metastatic clear-cell renal cell carcinoma

Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from ab-2100 infusion up to 24 months post-infusion

Awards & highlights

Study Summary

This trial is testing a new cell product called AB-2100 to see if it is safe and effective. They will enroll around 60 patients for phase 1 and around 70 patients for phase

Who is the study for?

This trial is for people who have had kidney cancer (clear-cell Renal Cell Carcinoma) come back after treatment. Specific details about who can join are not provided, but typically participants need to meet certain health standards and may be excluded based on factors that could affect the study or their safety.Check my eligibility

What is being tested?

The trial is testing AB-2100, a new type of cell therapy, in two stages: first to see if it's safe (phase 1 with around 60 patients), then to check how well it works (phase 2 with about 70 patients). It's an open-label study which means everyone knows they're getting the experimental treatment.See study design

What are the potential side effects?

Specific side effects of AB-2100 aren't listed here, but cell therapies like this one can sometimes cause immune reactions, flu-like symptoms, fatigue, and possible risks related to how the cells are administered.

Eligibility Criteria

Inclusion Criteria

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

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My kidney cancer has spread and is of the clear-cell type.

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I am fully active or can carry out light work.

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I've had treatments targeting the immune system and blood vessel growth for my advanced cancer, but they didn't work or caused severe side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from ab-2100 infusion up to 24 months post-infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from ab-2100 infusion up to 24 months post-infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and from ab-2100 infusion up to 24 months post-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 (Dose escalation): incidence of adverse events

Phase 2 (Cohort expansion): Objective response rate (ORR)

Trial Design

1Treatment groups

Experimental Treatment

Group I: AB-2100Experimental Treatment1 Intervention

Patients receive fludarabine and cyclophosphamide intravenously on days -5 to -3. Patients receive a single dose of AB-2100 intravenously on day 0.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arsenal Biosciences, Inc.Lead Sponsor

1 Previous Clinical Trials

60 Total Patients Enrolled

1 Trials studying Recurrence

60 Patients Enrolled for Recurrence

Arsenal BiosciencesStudy DirectorArsenal Biosciences

1 Previous Clinical Trials

60 Total Patients Enrolled

1 Trials studying Recurrence

60 Patients Enrolled for Recurrence

Frequently Asked Questions

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

Are there openings for new participants in this ongoing clinical trial?

"As per clinicaltrials.gov, this particular research investigation is not currently seeking participants. Originally posted on February 26, 2024, the latest update was made on February 6, 2024. Despite its inactive status in recruitment, there are a substantial number of 3381 other ongoing trials actively looking for eligible candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AB-2100, an Integrated Circuit T (ICT) Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC)

2024. "AB-2100, an Integrated Circuit T (ICT) Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06245915.

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