130 Participants Needed

AB-2100 Cell Therapy for Kidney Cancer

Recruiting at 8 trial locations
AB
Overseen ByArsenal Biosciences
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Arsenal Biosciences, Inc.
Must be taking: Immune checkpoint inhibitors, VEGF-targeted therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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 phase 1 and approximately 70 patients in phase 2.

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.

What data supports the effectiveness of the treatment AB-2100 for kidney cancer?

Research shows that immunotherapy, which includes treatments that activate the body's immune system to fight cancer, has been promising for kidney cancer. Studies have explored various immune-based treatments, such as those using specific immune cells, which have shown encouraging results in targeting kidney cancer.12345

How is the AB-2100 treatment for kidney cancer different from other treatments?

AB-2100 is a cell therapy, which is a type of treatment that uses living cells to fight cancer, and it is part of a new wave of treatments focusing on the immune system's ability to target cancer cells. This approach is different from traditional treatments like chemotherapy and radiotherapy, which often have limited effectiveness in kidney cancer.12367

Research Team

AB

Arsenal Biosciences

Principal Investigator

Arsenal Biosciences

Eligibility Criteria

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.
See 3 more

Exclusion Criteria

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.
I have previously been treated with anti-CA9 therapies.
See 6 more

Timeline

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

Treatment Details

Interventions

  • AB-2100
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: AB-2100Experimental Treatment1 Intervention
Patients receive fludarabine and cyclophosphamide intravenously on days -5 to -3. Patients receive a single dose of AB-2100 intravenously on day 0.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arsenal Biosciences, Inc.

Lead Sponsor

Trials
2
Recruited
150+

Findings from Research

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.
Will the dark sky over advanced renal cell carcinoma soon become brighter?D'Hondt, V., Gil, T., Lalami, Y., et al.[2007]
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.
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, 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.
Immunotherapy of renal cell carcinoma.Gouttefangeas, C., Stenzl, A., Stevanović, S., et al.[2020]

References

Will the dark sky over advanced renal cell carcinoma soon become brighter? [2007]
Effectiveness of allogeneic CD3AK cells on transplanted human renal cell cancer in mice with severe combined immune deficiency. [2017]
Immunotherapy of renal cell carcinoma. [2020]
Infusion of the allogeneic cell line NK-92 in patients with advanced renal cell cancer or melanoma: a phase I trial. [2022]
Influence of CD80, interleukin-2, and interleukin-7 expression in human renal cell carcinoma on the expansion, function, and survival of tumor-specific CTLs. [2017]
6.Russia (Federation)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]. [2012]
[Cell therapy in renal cell carcinoma]. [2009]