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CAR T-cell Therapy

AB-2100 Cell Therapy for Kidney Cancer

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
Must not have
Untreated brain metastasis
Prior treatment with anti-CA9 therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from ab-2100 infusion up to 24 months post-infusion
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastasis that has not been treated.
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I have previously been treated with anti-CA9 therapies.
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I needed a procedure to remove fluid from my chest for comfort within the last 28 days.
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I have an autoimmune disease that needs strong medication to control.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1 (Dose escalation): incidence of adverse events
Phase 2 (Cohort expansion): Objective response rate (ORR)

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: 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.

Find a Location

Who is running the clinical trial?

Arsenal Biosciences, Inc.Lead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
Arsenal BiosciencesStudy DirectorArsenal Biosciences
1 Previous Clinical Trials
60 Total Patients Enrolled
~32 spots leftby Feb 2025
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