AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT05617755|
Recruitment Status : Recruiting
First Posted : November 15, 2022
Last Update Posted : January 31, 2023
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Ovarian Epithelial Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms Neoplasms, Glandular and Epithelial Ovarian Diseases Genital Neoplasm, Female Abdominal Neoplasm Recurrence||Biological: AB-1015||Phase 1|
This study is intended for the patients who have been diagnosed with Epithelial Ovarian Cancer that either came back or did not improve after platinum treatments (platinum resistant). 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. This treatment has not been approved by the Food and Drug Administration.
The goal of this study is to calculate the maximum tolerated dose of the AB-1015 cells. T cells are part of the immune system that protect the body from infection and may help fight cancer. The T cells given in this study will come from the patient and will have a genetic circuit/logic gate put in them that makes them able to recognize alkaline phosphatase, germ line/placental (ALPG/P) and mesothelin (MSLN), 2 proteins on the surface of tumor cells. These logic-gated T cells may help the body's immune system identify and kill cancer cells while sparing normal healthy tissues from toxicity.
The AB-1015 cells are given intravenously, after completing 3 rounds of conditioning chemotherapy administered over 3 consecutive days. Conditioning chemotherapy prepares the body to receive the AB-1015 cells. If they continue to meet the eligibility criteria, AB-1015 cells will be given to them 2 days after the last conditioning chemotherapy round. A single infusion of the AB-1015 cells will be given to the subject intravenously.
After completion of study treatment, patients are followed with serial measurements of safety, tolerability and response.
This is a research study to obtain new information that may help people in the future.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Phase 1 Study to Evaluate the Safety and Efficacy of AB-1015 in Patients With Resistant/Refractory Epithelial Ovarian Cancer|
|Actual Study Start Date :||November 29, 2022|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||February 2027|
Patients receive fludarabine and cyclophosphamide intravenously on days -5 to -3. Patients receive a single dose of AB-1015 intravenously on day 0.
autologous T cell therapy
Other Name: Integrated Circuit T (ICT) cells
- Incidence of adverse events and dose limiting toxicities (DLTs) [ Time Frame: Up to 2 years post treatment ]Toxicity grading will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5.0 and monitoring of adverse events. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) events will be graded according to the criteria outlined in the protocol.
- Maximal tolerated dose of AB-1015 [ Time Frame: Up to 21 days ]Will be determined by a 3x3 dose escalation study
- Number of AB-1015 cells [ Time Frame: Up to 1 year post treatment ]Number of AB-1015 cells present in patients treatment with AB-1015
- Evidence of anti-tumor activity [ Time Frame: Up to 2 years post treatment ]Assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Co-expression of ALPG and MSLN targets on tumor cells [ Time Frame: Up to 2 years post treatment ]Assessment by immunohistochemistry (or similar method)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05617755
|Contact: Arsenal Biosciencesemail@example.com|
|United States, Iowa|
|U. of Iowa Health Care||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Study Director:||Arsenal Biosciences||Arsenal Biosciences|