What side effects are associated with this type of intervention?

Common treatments for ovarian cancer include chemotherapy, targeted therapy, and investigational cellular therapies like the AB-1015 cell product. Chemotherapy, often involving drugs like paclitaxel and carboplatin, can cause side effects such as neurotoxicity, granulocytopenia, anemia, and gastrointestinal issues. Targeted therapies, including PARP inhibitors, may lead to fatigue, nausea, and hematologic toxicities. Cellular therapies, while still under investigation, may present unique side effects such as cytokine release syndrome, immune-related adverse events, and infusion reactions. It is crucial to discuss these potential side effects with a healthcare provider to tailor the treatment plan to the patient's needs and tolerance.

What prior FDA approvals exist?

The FDA has approved several advanced treatments for ovarian cancer, including targeted therapies and immunotherapies. Notably, PARP inhibitors like olaparib, niraparib, and rucaparib have been approved for patients with BRCA mutations or those who have shown a response to platinum-based chemotherapy. Bevacizumab, an angiogenesis inhibitor, is also approved for use in combination with chemotherapy. While specific cellular therapies like the AB-1015 cell product are still under investigation, these advanced treatments represent significant progress in the management of ovarian cancer.

What other types of research exist?

Promising novel alternatives to AB-1015 cell product for ovarian cancer patients include: 1) PARP inhibitors such as olaparib and niraparib, which have shown efficacy in patients with BRCA mutations. 2) Anti-angiogenic agents like bevacizumab, which can be used in combination with chemotherapy. 3) Immune checkpoint inhibitors such as pembrolizumab, which have shown promise in certain subsets of ovarian cancer patients. 4) Other cellular therapies like CAR-T cells targeting specific ovarian cancer antigens, which are currently being investigated in clinical trials.

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CAR T-cell Therapy

ICT Cell Therapy for Ovarian Cancer

Phase 1

Waitlist Available

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

Must not have

Active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment

Clinically significant pericardial effusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment using modified immune cells (AB-1015) for patients with ovarian cancer that didn't respond to standard treatments. The modified cells are designed to target and kill cancer cells. The goal is to find a safe dose and see if the treatment helps fight the cancer. Modified immune cells, such as those used in AB-1015, have shown good curative effects in treating ovarian cancer.

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.

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.

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

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My cancer is a type of advanced ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based chemotherapy.

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I've had 2-3 treatments for my cancer, including platinum and PARP inhibitor if BRCA1/2 positive.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune disease that needs strong medication to control.

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I have a serious fluid buildup around my heart.

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I have brain metastasis that has not been treated.

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I have moderate to severe heart condition limitations.

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I haven't had chemotherapy in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years post treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events and dose limiting toxicities (DLTs)

Maximal tolerated dose of AB-1015

Secondary study objectives

Co-expression of ALPG and MSLN targets on tumor cells

Evidence of anti-tumor activity

Number of AB-1015 cells

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-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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian cancer include chemotherapy, targeted therapy, and cellular therapy. Chemotherapy, such as carboplatin and paclitaxel, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Targeted therapies, like PARP inhibitors, interfere with specific molecules involved in cancer cell growth and survival, offering a more precise approach. Cellular therapies, such as the AB-1015 cell product, involve modifying a patient's own immune cells to better recognize and attack cancer cells. This is particularly significant for ovarian cancer patients as it offers a personalized treatment option that can potentially overcome resistance to traditional therapies and improve outcomes.