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Sponsors and Collaborators: |
Bellicum Pharmaceuticals M.D. Anderson Cancer Center The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston Memorial Hermann Hospital Baylor College of Medicine |
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Information provided by: | Bellicum Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00868595 |
This is a Phase I/II, non-randomized, multiple-dose, 3+3 dose-escalation study of the safety, pharmacokinetics, biomarkers, preliminary efficacy and patient-reported outcomes of therapeutic vaccine, BP-GMAX-CD1, plus activating agent, AP1903, in patients with androgen-independent prostate cancer.
Condition | Intervention | Phase |
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Androgen-Independent Prostate Cancer |
Biological: BP-GMAX-CD1 Drug: AP1903 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | A Phase I/II, Non-Randomized, Multiple Dose, Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Therapeutic Vaccine, BP-GMAX-CD1, Plus Activating Agent, AP1903, in Patients With Androgen-Independent Prostate Cancer |
Estimated Enrollment: | 24 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Every Week Schedule of Treatment: Active Comparator
Weekly Schedule: Cohort 1: BP-GMAX-CD1, 4 x 10*6 cells Cohort 2: BP-GMAX-CD1, 12.5 x 10*6 cells Cohort 3: BP-GMAX-CD1, 40 x 10*6 cells Subjects will receive five intradermal (ID) injections totaling 1 mL of BP-GMAX-CD1 at 3 dose levels for an initial 6 doses, followed by boosters every 8 weeks for patients who do not progress. At 24 hours after each vaccination, a single dose of the activating agent, AP1903 for Injection, will be administered at a fixed dose of 0.4 mg/kg via intravenous (IV) infusion over 2 hours. |
Biological: BP-GMAX-CD1
Vaccine
Drug: AP1903
Activating agent, infusion
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Every Other Week Schedule: Active Comparator
Every Other Week Schedule: Cohort 1: BP-GMAX-CD1, 4 x 10*6 cells Cohort 2: BP-GMAX-CD1, 12.5 x 10*6 cells Cohort 3: BP-GMAX-CD1, 40 x 10*6 cells Subjects will receive five intradermal (ID) injections totaling 1 mL of BP-GMAX-CD1 at 3 dose levels for an initial 6 doses, followed by boosters every 8 weeks for patients who do not progress. At 24 hours after each vaccination, a single dose of the activating agent, AP1903 for Injection, will be administered at a fixed dose of 0.4 mg/kg via intravenous (IV) infusion over 2 hours. |
Biological: BP-GMAX-CD1
Vaccine
Drug: AP1903
Activating agent, infusion
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Patients will be screened within 6 weeks prior to Week 1. A total of 6 cohorts, consisting of 3 to 6 patients each, are planned to receive five intradermal (ID) injections totaling 1 mL of BP-GMAX-CD1 at 3 doses levels on two different dosing schedules, weekly or every other week, for an initial 6 doses.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other Criteria Apply however are not listed
Contact: Felecia Ortiz, R.N., B.S.N. | 713-704-4137 | Felecia.Ortiz@uth.tmc.edu |
United States, Texas | |
University of Texas Health Science Center Houston, CRU | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Felecia Ortiz, R.N., B.S.N 713-704-4137 Felecia.Ortiz@uth.tmc.edu | |
Principal Investigator: Guru Sonpavde, MD |
Principal Investigator: | Guru Sonpavde, MD | University of Texas Health Science Center Houston - CCTS |
Responsible Party: | Bellicum Pharmaceuticals, Inc. ( Kevin Slawin, M.D. , Sponsor Representative ) |
Study ID Numbers: | BP-PC-001 |
Study First Received: | March 24, 2009 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00868595 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Androgens |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |