- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01823978
Safety Study of BPX-201 Dendritic Cell Vaccine Plus AP1903 in Metastatic Castrate Resistent Prostate Cancer
October 4, 2019 updated by: Bellicum Pharmaceuticals
A Phase I Study of BPX-201 Vaccine Plus AP1903 in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
This is a Phase I, non-randomized, dose escalation study of the safety, biomarkers, and preliminary efficacy of dendritic cell vaccine, BPX-201, plus activating agent, AP1903, in patients with metastatic castrate resistant prostate cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a Phase I study of therapeutic vaccine, BPX-201, plus activating agent, AP1903, in patients with mCRPC.
Patients will be screened within 8 weeks prior to first vaccine administration (4 weeks prior to leukapheresis).
The trial design consists of 3 cohorts of 6 patients each, receiving escalating doses of BPX-201 of 10 million (M), 20M and 40M cells, respectively.
Dose escalation will occur according to a 3+3 design.
Patients will receive administration of BPX-201 every other week for 6 cycles (1 cycle equals 2 weeks).
Approximately 1.6 mL of BPX-201 will be administered as 8 intradermal injections (200μL each) at each treatment visit.
On the day following each vaccination, a single 40 mg dose of the activating agent, AP1903, will be administered via intravenous (IV) infusion over 2 hours.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35249
- UAB Comprehensive Cancer Center
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Texas
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Dallas, Texas, United States, 75246
- Baylor Charles Sammons Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Written informed consent
- 18 years of age or older
- Histologically confirmed, metastatic prostate cancer (positive bone scan and/or measurable disease on CT scan and/or MRI of the abdomen and pelvis).
- Progressive disease after androgen deprivation, as defined by Prostate Cancer Working Group 2 and/or Response Evaluation Criteria in Solid Tumors criteria
Laboratory requirements:
- Absolute neutrophil count (ANC) ≥ 1500/μL
- Bilirubin < 1.5 x ULN
- Hemoglobin > 8 g/dL
- PSA > 2 ng/mL
- Platelets > 100,000/µL
- AST and ALT < 2.5 x ULN
- Creatinine clearance ≥ 60mL/min
- Testosterone < 50 ng/dL
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 and life expectancy > 12 weeks
- Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g. Saw Palmetto, PC-SPES), or agents such as abiraterone, TAK700, MDV3100 as well as any systemic corticosteroid use, must discontinue the agent for at least four weeks prior to study treatment. Progressive disease as defined above must be documented after discontinuation of any hormonal therapy (with the exception of a LHRH agonist).
- Prior radiation therapy must be completed > 4 weeks prior to enrollment and the patient must have recovered from all toxicity. Prior radiopharmaceuticals (strontium, samarium) must be completed ≥ 8 weeks prior to enrollment.
- Because of the unknown potential risk to a gamete and/or developing embryo from these investigational therapies, patients must agree to use adequate contraception (barrier method for males) for the duration of study participation, and for three months after discontinuing therapy.
Exclusion Criteria:
- Prior chemotherapy for prostate cancer, with the exception of neo-adjuvant chemotherapy, because of the potential effect of chemotherapy on the immune system.
- Prior sipuleucel-T treatment or investigational immunotherapy.
- Prostate cancer pain requiring regularly scheduled narcotics.
- Current treatment with systemic steroid therapy (inhaled/topical steroids are acceptable). Systemic corticosteroids must be discontinued for at least 4 weeks prior to first treatment.
- Clinically active autoimmune disease.
- Diagnosis of prostate cancer with neuroendocrine differentiation
- Known presence of central nervous system metastases, pleural effusions or ascites
- Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves.
- Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association Class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months).
Concurrent or prior malignancy except for the following:
- Adequately treated basal or squamous cell skin cancer
- Adequately treated stage I or II cancer from which the patient is currently in complete remission
- Any other cancer from which the patient has been disease-free for 5 years
- Known HIV or other history of immunodeficiency disorder.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illness.
- Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of BPX-201 and AP1903 hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
- Any non-oncology vaccine therapy used for prevention of infectious diseases for up to 1 month before BPX-201
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BPX-201
BPX-201 vaccine plus AP1903
|
The trial design consists of 3 cohorts of 6 patients each, receiving escalating doses of BPX-201 of 10 million (M), 20M and 40M cells, respectively.
Dose escalation will occur according to a 3+3 design.
Patients will receive administration of BPX-201 every other week for 6 cycles (1 cycle equals 2 weeks).
Approximately 1.6 mL of BPX-201 will be administered as 8 intradermal injections (200μL each) at each treatment visit.
On the day following each vaccination, a single 40 mg dose of the activating agent, AP1903, will be administered via intravenous (IV) infusion over 2 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with adverse events as a measure of safety and tolerability
Time Frame: 2 years
|
Safety will be measured through the monitoring of AEs, clinical laboratory parameters (hematology, serum chemistry, and urinalysis), vital sign measurements, and physical examinations.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prostatic specific antigen
Time Frame: 3 months
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Measure PSA response and PSA doubling time as measured from PSA nadir through 12 weeks
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3 months
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Progression free survival
Time Frame: 2 years
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Rate of PFS
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2 years
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Reduction in circulating tumor cells
Time Frame: 2 years
|
Change from baseline in number of circulating tumor cells
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2 years
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Response to chemotherapy after vaccine
Time Frame: 2 years
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Response to chemotherapy upon progression
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
March 21, 2013
First Submitted That Met QC Criteria
April 1, 2013
First Posted (Estimate)
April 4, 2013
Study Record Updates
Last Update Posted (Actual)
October 8, 2019
Last Update Submitted That Met QC Criteria
October 4, 2019
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP-PC-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Castrate Resistent Prostate Cancer
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-
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