ICT Cell Therapy for Ovarian Cancer

Not currently recruiting at 10 trial locations

Overseen By Arsenal 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies a new treatment called AB-1015, an investigational cell therapy, for individuals with a specific type of ovarian cancer that has returned, spread, and resists platinum-based treatments. The goal is to determine a safe dose of AB-1015 for future studies. Participants receive the treatment intravenously after initial medication prepares their bodies. The trial seeks individuals with advanced ovarian, fallopian tube, or primary peritoneal cancer who have tried at least two other treatments without success. As a Phase 1 trial, this research aims to understand how AB-1015 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that AB-1015, a new cell therapy, is currently being tested for safety in treating ovarian cancer. Earlier studies focused on ensuring that AB-1015 targets only cancer cells, not healthy ones, to minimize side effects. The treatment effectively attacked cancer cells. However, as this is a Phase 1 trial, the primary goal is to assess the treatment's safety in humans and determine the optimal dose for future studies. This early phase provides limited information on human safety but is crucial for understanding how well people can tolerate the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

AB-1015 is unique because it uses a novel approach called ICT (immune cell therapy) to tackle ovarian cancer. Unlike traditional treatments like chemotherapy, AB-1015 involves reprogramming the body's own immune cells to better recognize and fight cancer cells. This targeted mechanism offers the potential for more precise and effective treatment with potentially fewer side effects. Researchers are excited because this could open new doors for treating ovarian cancer, especially in cases where conventional treatments have limited success.

What evidence suggests that AB-1015 might be an effective treatment for ovarian cancer?

Research has shown that AB-1015, a new type of T cell therapy, may help treat ovarian cancer. This treatment uses specially designed T cells to find and destroy cancer cells while sparing healthy ones. In lab studies, AB-1015 eliminated tumors with specific markers, such as ALPG/P and MSLN, without harming normal cells. These early results suggest that AB-1015 could effectively target and reduce ovarian cancer cells. However, as human trials, including this one, are just beginning, further research is needed to confirm these effects in patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Arsenal Biosciences

Principal Investigator

Arsenal Biosciences

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: AB-1015 Experimental Treatment 1 Intervention

Patients receive fludarabine and cyclophosphamide intravenously on days -5 to -3. Patients receive a single dose of AB-1015 intravenously on day 0.

Who Is Running the Clinical Trial?

Arsenal Biosciences, Inc.

Lead Sponsor

Trials

2

Recruited

150+

Published Research Related to This Trial

Adoptive cell therapy (ACT) represents a promising immunotherapy for epithelial ovarian cancer (EOC), utilizing personalized lymphocyte manipulation to enhance cancer rejection, with various strategies including tumor-infiltrating lymphocytes and CAR-T cells.

Recent advancements in genomics and immuno-engineering have improved the effectiveness of ACT, particularly through neoantigen-based strategies and dendritic cell-based immunotherapies, showing modest but encouraging results in EOC treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell therapies in ovarian cancer. Sarivalasis, A., Morotti, M., Mulvey, A., et al.[2021]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05617755

NCT05617755 | AB-1015, an Integrated Circuit T (ICT) Cell ... The purpose of this study is to test the safety of using a new treatment called Integrated Circuit T (ICT) cells (AB-1015 cells) in patients with ovarian cancer ...

2. jitc.bmj.com jitc.bmj.com/content/10/Suppl_2/A292

277 Development of a robust manufacturing process for AB ... AB-1015 is an autologous, integrated circuit T cell (ICT) product for the treatment of platinum-resistant ovarian cancer. AB-1015 includes a ...

3. crisprmedicinenews.com crisprmedicinenews.com/clinical-trial/epithelial-ovarian-cancer-eoc-nct05617755/

Disease: Epithelial Ovarian Cancer, EOC, (NCT05617755) The purpose of this study is to test the safety of using a new treatment called Integrated Circuit T (ICT) cells (AB-1015 cells) in patients with ovarian ...

4. arsenalbio.com arsenalbio.com/wp-content/uploads/2024/04/Arsenalbio_20240405.pdf

Arsenal Biosciences Announces Presentation of Four ... AB-1015 is being studied in a phase 1 clinical trial as a potential therapy for ovarian cancer. (NCT05617755) contains an “AND” logic gate ...

5. aacrjournals.org aacrjournals.org/cancerres/article/82/12_Supplement/585/702443/Abstract-585-AB-1015-a-novel-integrated-circuit-T

AB-1015, a novel integrated circuit T cells containing an ALPG ... AB-1015 ICT cells eliminated ALPG/P+MSLN+ tumors, while sparing tumors that lacked ALPG/P. To assess the ability of AB-1015 to mediate killing ...

6. withpower.com withpower.com/trial/phase-1-genital-neoplasms-female-10-2022-fed33

ICT Cell Therapy for Ovarian Cancer · Info for Participants This trial tests a new treatment using modified immune cells (AB-1015) for patients with ovarian cancer that didn't respond to standard treatments.