AB-2100 Cell Therapy for Kidney Cancer
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
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
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.
12345How 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.
12367Eligibility 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.
+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.
+6 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
Perlmutter Cancer Center - NYU Langone HealthNew York, NY
Dana Farber Cancer InstitueBoston, MA
Huntsman Cancer Institute - Univ of Utah HealthSalt Lake City, UT
More Trial Locations
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Who Is Running the Clinical Trial?
Arsenal Biosciences, Inc.Lead Sponsor
References
Will the dark sky over advanced renal cell carcinoma soon become brighter? [2007]Until recently, immunotherapy has been the most efficient treatment for advanced renal cell carcinoma, but clinical results are largely unsatisfactory. More promising agents are being developed as a result of an improved understanding of the biology of the disease. Several agents that target known biological abnormalities of the disease are now being tested in the clinic. This review describes the encouraging clinical results obtained to date with these new drugs or combinations of drugs.
Effectiveness of allogeneic CD3AK cells on transplanted human renal cell cancer in mice with severe combined immune deficiency. [2017]To assess the activity of allogeneic anti-CD3 antibody induced activated killer (CD3AK) cells on transplanted human renal cell cancer (RCC) in mice with severe combined immune deficiency (SCID), thus to provide theoretical and experimental support for clinical application of allogeneic CD3AK cells in the treatment of RCC.
Immunotherapy of renal cell carcinoma. [2020]Carcinomas of the kidney generally have a poor prognosis and respond minimally to classical radiotherapy or chemotherapy. Immunotherapy constitutes an interesting alternative to these established forms of treatment, and indeed, cytokine-based therapies have been used for many years, leading to favorable clinical responses in a small subset of patients. During the past few years, immunotherapeutical trials targeting renal cell tumor-associated antigens have also been reported, with diverse passive or active approaches using antibodies or aimed at activating tumor-directed T lymphocytes. The following review presents the results and the progress made in the field, including classical cytokine treatments, non-myeloablative stem cell transplantation and antigen specific-based trials, with special focus on T-cell studies. In consideration of the few specific molecular targets described so far for this tumor entity, current strategies which can lead to the identification of new relevant antigens will be discussed. Hopefully these will very soon contribute to an improvement in renal cell carcinoma specific immunotherapy and its evaluation.
Infusion of the allogeneic cell line NK-92 in patients with advanced renal cell cancer or melanoma: a phase I trial. [2022]Renal cell cancer and malignant melanoma are two types of cancer that are responsive to immunotherapy. In this phase I dose-escalation study, the feasibility of large-scale expansion and safety of administering ex vivo-expanded NK-92 cells as allogeneic cellular immunotherapy in patients with refractory renal cell cancer and melanoma were determined.
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]A renal cell carcinoma (RCC) line, RCC-26, has been identified as a suitable candidate for development of an allogeneic tumor cell vaccine based on its expression of a variety of tumor-associated antigens (TAA). To improve immunogenicity, RCC-26 cells were genetically engineered to express CD80 alone or in combination with interleukin (IL)-2 or IL-7. The effect of these modifications on proliferation, function, and survival of autologous and allogeneic tumor-specific CTLs was assessed.
[Phase I-II trial of gene therapy with tag-7 modified autologous tumor cells in patients with metastatic solid tumors]. [2012]A prospective (phase I-II) trial was undertaken to study the efficacy and toxicity of gene therapy with tag 70-modified autologous tumor cells in 32 patients with metastatic renal cell carcinoma (RC) (5) and melanoma (MBL) (27) treated at the Institute's Clinic (2001-2003). Resected material was reduced to cell culture, which was transfected with tag 70 gene and devitalized by irradiation. Immune blotting was used for gene expression. Clinical and immunological effectiveness was evaluated in 22 patients (MBL--17 and RC--5) who received 1-6 injections (3 on the average). Full course of vaccination was given to 8 (MBL--6 and RC--2). No complete or partial response was reported while least regression (50%) was registered in a case of RC metastatic to the lung. According to CT and ultrasound evidence, stabilization was achieved in 5 (23.8%) (MBL--4 and RC--1). Relapse-free period was 6.5+/-3.5 months beginning from the start of treatment. The vaccine was well tolerated while DHT reaction was observed in 47.6% (10 out of 17) of primary immunized patients. A trend of increased content of T- and B-cells in peripheral blood and intensified functional activity was established.
[Cell therapy in renal cell carcinoma]. [2009]Cellular therapy in renal cell carcinoma has to be included in a strategy based on the known sensitivity to immunotherapy of renal cell carcinoma. Cellular therapy was previously initiated with Lymphokine Activated Killer cells (LAK) then Tumor Infiltrating Lymphocytes (TIL). Yet, major clinical evaluations are performed on dendritic cells and allogeneic blood stem cell transplantation.