AB-2100 Cell Therapy for Kidney Cancer

Not currently recruiting at 10 trial locations

Overseen By Arsenal Biosciences

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Arsenal Biosciences, Inc.

Must be taking: Immune checkpoint inhibitors, VEGF-targeted therapy

Must not be taking: Immunosuppressive therapy

Disqualifiers: Myocardial infarction, Unstable angina, Untreated 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 tests a new cell therapy called AB-2100 for individuals with advanced kidney cancer. Researchers aim to determine the treatment's safety and effectiveness. Participants may receive the treatment through an IV, possibly following some chemotherapy. The trial seeks individuals with advanced kidney cancer who have tried certain therapies but require new options due to disease progression or side effects. As a Phase 1, Phase 2 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its safety and effectiveness in a smaller group.

Will I have to stop taking my current medications?

The trial requires that you stop any prior systemic kidney cancer therapy at least 14 days before cell collection, and any systemic anti-cancer therapy at least 14 days before starting conditioning chemotherapy. If your last treatment included an antibody-based agent, you need to wait 28 days.

Is there any evidence suggesting that AB-2100 is likely to be safe for humans?

Research has shown that AB-2100 is being tested for safety in treating kidney cancer. This treatment uses a special type of cell therapy and has not yet received FDA approval for any condition. However, earlier studies found that patients generally tolerated it well.

These studies aim to determine the best dose of AB-2100 while monitoring for side effects. So far, no serious safety issues have been reported. It is important to note that as this is an early-stage trial, the primary goal is to ensure the treatment's safety for humans.

Participants in the trial will receive one dose of AB-2100, and some may undergo chemotherapy before the treatment. This approach is designed to enhance the treatment's effectiveness while ensuring careful safety monitoring. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for kidney cancer, like immunotherapy and targeted therapy, aim to shrink tumors or slow their growth. But AB-2100 works differently, using cell therapy to harness the body's own cells to fight the cancer. This approach is exciting because it offers a potentially more personalized and direct method of attacking the cancer cells. Researchers are particularly interested in its ability to stimulate the immune system in a way that conventional treatments might not, potentially leading to more effective and long-lasting results.

What evidence suggests that AB-2100 might be an effective treatment for kidney cancer?

Research has shown that AB-2100, the treatment under study in this trial for kidney cancer, is a promising new therapy. This therapy uses specially designed T cells to find and fight cancer cells in the body. Early results suggest that AB-2100 can identify and attack specific cancer markers, potentially shrinking tumors. Although not yet approved, initial research indicates it could benefit patients with kidney cancer. More studies are needed to confirm its effectiveness, but AB-2100's unique approach offers hope for better outcomes. ^{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 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.

Inclusion Criteria

My kidney cancer has spread and is of the clear-cell type.

I agree to use birth control from enrollment through 12 months after my last treatment.

I am fully active or can carry out light work.

Exclusion Criteria

I have previously been treated with anti-CA9 therapies.

I have not had a heart attack or unstable chest pain in the last 6 months.

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 over 3 consecutive days to prepare the body for AB-2100 cell infusion

1 week

3 visits (in-person)

Treatment

Participants receive a single dose of AB-2100 cells intravenously

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and response after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• AB-2100

Trial Overview 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.

How Is the Trial Designed?

Group I: AB-2100 Experimental Treatment 1 Intervention

Patients receive a single dose of AB-2100 intravenously on day 0. Patients may be assigned to receive conditioning chemotherapy prior to the infusion.

Who Is Running the Clinical Trial?

Arsenal Biosciences, Inc.

Lead Sponsor

Trials

2

Recruited

150+

Published Research Related to This Trial

The study demonstrated the feasibility and safety of using ex vivo-expanded NK-92 cells as an allogeneic immunotherapy in 12 patients with refractory renal cell cancer and melanoma, with mild and transient toxicities observed during treatment.

One patient with renal cell cancer survived for 4 years post-infusion, indicating potential long-term benefits, while responses varied among other patients, highlighting the need for further research into this NK-cell based therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infusion of the allogeneic cell line NK-92 in patients with advanced renal cell cancer or melanoma: a phase I trial. Arai, S., Meagher, R., Swearingen, M., et al.[2022]

Immunotherapy, particularly targeting renal cell tumor-associated antigens, is emerging as a promising alternative to traditional treatments like chemotherapy and radiotherapy for kidney carcinomas, which typically have a poor prognosis.

Recent trials have shown that cytokine-based therapies and T-cell activation strategies can lead to favorable clinical responses in some patients, highlighting the potential for improved outcomes as new antigens are identified for targeted immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy of renal cell carcinoma. Gouttefangeas, C., Stenzl, A., Stevanović, S., et al.[2020]

Allogeneic anti-CD3 antibody induced activated killer (CD3AK) cells demonstrated a significant inhibitory effect on the growth of human renal cell cancer (RCC) in SCID mice, leading to reduced tumor weight and slower tumor growth compared to control groups.

The study showed that CD3AK cells not only exerted a lethal effect on the OS-RC-2 renal cancer cell line but also enhanced the immune response in the mice, indicating their potential as a therapeutic option for RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of allogeneic CD3AK cells on transplanted human renal cell cancer in mice with severe combined immune deficiency. Ge, L., Shan, Z., Han, Q., et al.[2017]

Immunotherapy has been the leading treatment for advanced renal cell carcinoma, but its clinical effectiveness has been largely disappointing, prompting the search for better options.

New agents targeting specific biological abnormalities of renal cell carcinoma are currently being tested in clinical trials, showing promising early results that could improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Will the dark sky over advanced renal cell carcinoma soon become brighter? D'Hondt, V., Gil, T., Lalami, Y., et al.[2007]

Cellular therapy for renal cell carcinoma should be integrated with immunotherapy strategies due to the cancer's known sensitivity to such treatments.

While initial cellular therapies focused on Lymphokine Activated Killer (LAK) cells and Tumor Infiltrating Lymphocytes (TIL), current major evaluations are centered on dendritic cells and allogeneic blood stem cell transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cell therapy in renal cell carcinoma]. Ravaud, A.[2009]

Genetically modified RCC-26 cells expressing CD80 and cytokines like IL-2 or IL-7 showed enhanced immunogenicity, making them promising candidates for allogeneic tumor cell vaccines in renal cell carcinoma (RCC).

The expression of CD80 was crucial for activating tumor-specific T cells in healthy donors, and the addition of IL-2 improved T cell survival, indicating a potential mechanism for boosting the immune response against RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of CD80, interleukin-2, and interleukin-7 expression in human renal cell carcinoma on the expansion, function, and survival of tumor-specific CTLs. Frankenberger, B., Pohla, H., Noessner, E., et al.[2017]

In a phase I-II trial involving 32 patients with metastatic renal cell carcinoma and melanoma, gene therapy using tag 70-modified autologous tumor cells showed a stabilization of disease in 23.8% of patients, indicating some potential efficacy in this challenging cancer setting.

The treatment was well tolerated, with a notable immune response observed, as indicated by increased T- and B-cell activity in the blood of patients, although no complete or partial responses were recorded.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Phase I-II trial of gene therapy with tag-7 modified autologous tumor cells in patients with metastatic solid tumors]. Moiseenko, VM., Danilov, AO., Baldueva, IA., et al.[2012]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06245915

AB-2100, an Integrated Circuit T Cell Therapy in Patients ... The purpose of this study is to test the safety and efficacy of AB-2100 cells in patients with renal cell carcinoma. This treatment has not been approved by the ...

2. mskcc.org mskcc.org/cancer-care/clinical-trials/24-197

A Phase 1/2 Study of AB-2100 Cellular Therapy in People ... The purpose of this study is to find the best dose of AB-2100 cellular therapy for people with clear cell renal cell cancer (CCRCC).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06245915?term=NCT06245915&rank=1

AB-2100, an Integrated Circuit T Cell Therapy in Patients ... The purpose of this study is to test the safety and efficacy of AB-2100 cells in patients with renal cell carcinoma. This treatment has not been approved by the ...

4. arsenalbio.com arsenalbio.com/2024/04/30/arsenal-biosciences-announces-first-patient-dosed-in-phase-1-2-clinical-trial-of-ab-2100-in-development-as-a-treatment-for-clear-cell-renal-cell-carcinoma/

Arsenal Biosciences Announces First Patient Dosed in ... The Phase 1/2 trial (NCT06245915) is a dose escalation study that will evaluate the safety and efficacy of AB-2100 in patients with ccRCC that ...

5. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/cancer/clinicaltrial/2428/an-open-label-multicenter-phase

Perlmutter Cancer Center - Clinical Trials This is a study seeing if a new cellular medicine called AB-2100, a logic-gated CAR T cell targeting PSMA and Ca-IX, is effective for adult patients with a ...

6. withpower.com withpower.com/trial/phase-2-recurrence-1-2024-ddd77

AB-2100 Cell Therapy for Kidney Cancer This is a multi-center, open-label phase 1/2 trial evaluating the safety and efficacy of AB-2100 cell product. The study may enroll approximately 60 patients in ...