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Compensation: Varies

Number of Visits: 4

Duration: 1 day

19 Participants Needed

ICT Cell Therapy for Ovarian Cancer

Recruiting at 10 trial locations

Overseen ByArsenal Biosciences

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Arsenal Biosciences, Inc.

Must not be taking: Immunosuppressive therapy

Disqualifiers: Cardiovascular disability, Brain metastasis, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had cytotoxic chemotherapy within 14 days before certain trial procedures. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment AB-1015 for ovarian cancer?

Research shows that immune therapies, like adoptive cell therapy (using a patient's own immune cells to fight cancer), have potential in treating ovarian cancer. In one study, a combination of immune therapies led to disease stabilization in several patients, suggesting that similar treatments might help manage ovarian cancer.¹ ² ³ ⁴ ⁵

Is ICT Cell Therapy for Ovarian Cancer safe for humans?

The studies suggest that cell therapies, including NK cells and CAR-T cells, have been tested for safety in ovarian cancer patients. These therapies have shown to be generally safe, with some side effects like cytokine-associated toxicities, but they are considered feasible and safe for use in humans.¹ ⁵ ⁶ ⁷ ⁸

How is the treatment AB-1015 different from other treatments for ovarian cancer?

AB-1015 is a type of cell therapy that uses the patient's own immune cells, which are modified and expanded outside the body, to target and destroy ovarian cancer cells. This approach is unique because it leverages the body's immune system to fight cancer, unlike traditional treatments like chemotherapy, which directly attack cancer cells but can also harm healthy cells.⁷ ⁹ ¹⁰ ¹¹ ¹²

What is the purpose of this trial?

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.

Research Team

Arsenal Biosciences

Principal Investigator

Arsenal Biosciences

Eligibility Criteria

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.

Inclusion Criteria

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

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

I am fully active or can carry out light work.

See 4 more

Exclusion Criteria

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

I have a serious fluid buildup around my heart.

I have brain metastasis that has not been treated.

See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning Chemotherapy

Participants receive fludarabine and cyclophosphamide intravenously on days -5 to -3 to prepare the body for AB-1015 cell infusion

1 week

3 visits (in-person)

Treatment

Participants receive a single dose of AB-1015 intravenously on day 0

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and response with serial measurements

Up to 2 years

Treatment Details

Interventions

AB-1015

Trial Overview 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.

Participant Groups

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 Clinic Near You

Who Is Running the Clinical Trial?

Arsenal Biosciences, Inc.

Lead Sponsor

Trials

Recruited

150+

Findings from Research

This phase I safety trial involves 12 patients with recurrent ovarian cancer, aiming to evaluate the safety and toxicity of intraperitoneal infusions of natural killer (NK) cells derived from umbilical cord blood, with or without prior immunosuppressive treatment.

The study will assess whether these NK cells can safely expand and remain active in the body, potentially offering a new therapeutic strategy for patients with a poor prognosis, especially if no severe toxicity is observed in the initial cohorts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraperitoneal infusion of ex vivo-cultured allogeneic NK cells in recurrent ovarian carcinoma patients (a phase I study).Hoogstad-van Evert, J., Bekkers, R., Ottevanger, N., et al.[2022]

Natural killer (NK) cells, whether derived from induced pluripotent stem cells (iPSCs) or activated peripheral blood (PB), significantly reduced tumor burden in a mouse model of ovarian cancer, demonstrating their potential as effective immunotherapy.

Mice treated with three doses of iPSC-derived or expanded PB-NK cells showed improved median survival (98 and 97 days, respectively) compared to untreated mice (73 days), indicating that iPSC-derived NK cells are as effective as PB-NK cells for treating ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induced Pluripotent Stem Cell-Derived Natural Killer Cells for Treatment of Ovarian Cancer.Hermanson, DL., Bendzick, L., Pribyl, L., et al.[2021]

Chimeric antigen receptor-modified T (CAR-T) cell therapy shows promising clinical efficacy in treating ovarian cancer, as supported by various preclinical experiments and clinical trials.

While CAR-T therapy offers a novel approach to cancer treatment, it is associated with side effects and toxicities, including cytokine release syndrome and 'on-target, off-tumor' effects, which need to be managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CAR-T cell therapy in ovarian cancer: from the bench to the bedside.Zhu, X., Cai, H., Zhao, L., et al.[2019]