AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)
Recruiting · NCT07285694 · Interventional (participants receive a specific treatment) · Lead sponsor: Arsenal Biosciences, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
AB-3028
What this trial is about
This is a multi-center, open-label Phase 1/2 trial evaluating the safety and efficacy of AB-3028 in subjects with metastatic castration resistant prostate cancer (mCRPC).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- At least 18 years of age at time of signing informed consent form.
- Histologically confirmed adenocarcinoma of the prostate, meeting all of the following criteria:
- Documented progressive metastatic castration-resistant prostate cancer (mCRPC) based on PCWG3 criteria.
- Prior prostate cancer treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy.
- PSMA+ by PSMA PET.
- Measurable disease by RECIST 1.1 criteria, or evaluable disease via measurable PSA (≥ 1 ng/mL) per PCWG3 criteria.
- Adequate organ functions.
- Key
Exclusion criteria
- Any prior systemic therapy for CRPC within 14 days prior to scheduled protocol required leukapheresis.
- Central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.
- Unwillingness to participate in an extended safety monitoring period.
Where it is running
9 locations listed across 7 US states.
- City of Hope - Duarte, California, United States
- USC Norris Comprehensive Cancer Center - Los Angeles, California, United States
- University of California, San Francisco - San Francisco, California, United States
- University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) - Aurora, Colorado, United States
- University of Iowa and Holden Comprehensive Cancer Center - Iowa City, Iowa, United States
- The University of Kansas Cancer Center - Fairway, Kansas, United States
- University of Minnesota - Minneapolis, Minnesota, United States
- Perlmutter Cancer Center - NYU Langone Health - New York, New York, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States