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CAR T-cell Therapy

ICT Cell Therapy for Ovarian Cancer

Phase 1
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
Recurrent, advanced, platinum resistant ovarian, fallopian tube, and primary peritoneal cancer with a histological diagnosis of high-grade serous histology
Must have received at least 2 lines of prior therapy including a platinum-based regimen if eligible and a poly-ADP ribose polymerase (PARP) inhibitor if BRCA1/2 mutated, with no more than 3 lines of prior therapy for the treatment of platinum resistant disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post treatment
Awards & highlights

Study Summary

This trial is testing a new medication to find a safe dose to use in further studies. Up to 12 people will be involved in each group.

Who is the study for?
This trial is for individuals with advanced ovarian, fallopian tube, or primary peritoneal cancer that's resistant to platinum-based treatments. Participants must have high-grade serous histology, at least two prior therapies (including a platinum regimen and possibly a PARP inhibitor if BRCA1/2 mutated), no more than three prior lines of therapy for their resistant disease, and be in good physical condition (ECOG score 0-1). Pregnant women are excluded.Check my eligibility
What is being tested?
AB-1015 cell therapy is being tested in this phase 1 trial to find the safest dose for future studies. The study will enroll subjects who've had recurrent cancer despite treatment and will use an escalating dose approach followed by additional enrollment into 'backfill cohorts' once safe levels are identified.See study design
What are the potential side effects?
While specific side effects of AB-1015 aren't listed here, similar cell therapies can cause immune reactions, fatigue, fever, chills, nausea or vomiting. Side effects may vary based on individual responses and the stage of treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is a type of advanced ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based chemotherapy.
Select...
I've had 2-3 treatments for my cancer, including platinum and PARP inhibitor if BRCA1/2 positive.
Select...
I am fully active or can carry out light work.
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My cancer worsened within 6 months of platinum treatment or my CA-125 levels doubled.
Select...
My organs are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events and dose limiting toxicities (DLTs)
Maximal tolerated dose of AB-1015
Secondary outcome measures
Co-expression of ALPG and MSLN targets on tumor cells
Evidence of anti-tumor activity
Number of AB-1015 cells

Trial Design

1Treatment groups
Experimental Treatment
Group I: AB-1015Experimental Treatment1 Intervention
Patients receive fludarabine and cyclophosphamide intravenously on days -5 to -3. Patients receive a single dose of AB-1015 intravenously on day 0.

Find a Location

Who is running the clinical trial?

Arsenal Biosciences, Inc.Lead Sponsor
1 Previous Clinical Trials
130 Total Patients Enrolled
Arsenal BiosciencesStudy DirectorArsenal Biosciences
1 Previous Clinical Trials
130 Total Patients Enrolled

Media Library

AB-1015 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05617755 — Phase 1
Ovarian Cancer Research Study Groups: AB-1015
Ovarian Cancer Clinical Trial 2023: AB-1015 Highlights & Side Effects. Trial Name: NCT05617755 — Phase 1
AB-1015 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05617755 — Phase 1
Ovarian Cancer Patient Testimony for trial: Trial Name: NCT05617755 — Phase 1

Frequently Asked Questions

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

Are there still slots available for those wishing to participate in this experiment?

"Affirmative. Clinicaltrials.gov displays that this research endeavour, initially posted on November 1st 2022, is currently recruiting volunteers. Approximately 60 subjects need to be signed up from a single site."

Answered by AI

Has AB-1015 been sanctioned by the FDA?

"Our team at Power gave AB-1015 a score of 1 since it is only in its first phase, thus there is limited evidence for safety and efficacy."

Answered by AI

What is the current intake of participants for this research endeavor?

"Affirmative, the clinical trial is actively recruiting as per data available on clinicaltrials.gov. This research project was originally published on November 1st 2022 and modified most recently on November 18th 2022. Presently, 60 participants are needed to be recruited from a single medical centre."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
UCSF Helen Diller Family Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’m already on my 3rd treatment for ovarian cancer and nothing is working, now the cancer is metastatic with lymphonodes compromised and tumors growing in the peritoneal, colon and hepatic system.
PatientReceived no prior treatments
I’m already on my 3rd treatment for ovarian cancer and nothing is working, now the cancer is metastatic with lymphonodes compromised and tumors growing in the peritoneal, colon and hepatic system and I’m BRCA1 positive.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

For how long I have to stay in the hospital if I qualify?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. UCSF Helen Diller Family Comprehensive Cancer Center: < 48 hours
Average response time
  • < 2 Days
~27 spots leftby Mar 2025