MTD Study of Vaccine BP-GMAX-CD1 Plus AP1903 to Treat Castrate Resistant Prostate Cancer

Patients will be screened within 6 weeks prior to Week 1. A total of 3 cohorts, consisting of
3 to 6 patients each, are planned to receive five to eight intradermal (ID) injections
totaling 1 mL up to 1.6mL of BPX-101 at 3 doses levels for an initial 6 doses.

Inclusion Criteria:

1. Males ≥ 18 years of age

2. Histological diagnosis of adenocarcinoma of the prostate

3. Documented evidence of distant metastasis of disease

4. No more than 1 prior chemotherapeutic, biologic or combination treatment regimen
(including vitamin D analogues) for CRPC. If previously treated, patients must be
recovered from all toxicities prior to entry into the study.

5. Patients must have current or historical evidence of disease progression concomitant
with surgical (orchiectomy) or medical castration (LHRH analogue); anti-androgen
withdrawal (4 weeks for flutamide and 6 weeks for nilutamide or bicalutamide) is
necessary only for patients on antiandrogens and a duration of response to
antiandrogens > 3months;

6. Testosterone < 50 ng/dL achieved via medical or surgical castration. Patients
receiving medical castration therapy must continue such therapy throughout the study.

7. Adequate hematologic, renal and liver function:

8. Negative serology tests for human immunodeficiency virus (HIV-1 and 2), human T-cell
lymphotropic virus (HTLV-1), hepatitis B surface antigen (HBsAg) and hepatitis C (HCV)

9. Karnofsky Performance Score (KPS) ≥ 70%

10. Life expectancy > 6 months

11. Written informed consent obtained prior to the initiation of study procedures

Exclusion Criteria:

1. The presence of brain metastases, pleural effusions or ascites

2. Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical
erosion on radiography > 50%), or spinal cord compression

3. A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous
cell skin cancers must have been adequately treated and the patient must be
disease-free at the time of registration. Patients with a history of stage I or II
other cancers must have been adequately treated and been disease-free for 3 years at
the time of registration.

4. More than 1 prior chemotherapy, biologic or combination treatment regimen (including
vitamin D analogues) for CRPC

5. Any treatment with radiopharmaceuticals, e.g. Strontium-89 and Samarium-153

6. Ketoconazole or antiandrogens (flutamide, nilutamide, bicalutamide) within 2 weeks
prior to registration. Patients who demonstrate an anti-androgen withdrawal response,
defined as a > 25% drop in PSA within 4 weeks (flutamide) or 6 weeks (nilutamide,
bicalutamide) of stopping a non-steroidal anti-androgen, are not eligible until the
PSA rises above the nadir observed after anti-androgen withdrawal.

7. Initiation of bisphosphonate therapy within 28 days prior to registration. Patients
taking bisphosphonates should not have their dosing regimen altered unless medically
warranted.

8. A requirement for systemic steroid or other immunosuppressive therapy for any reason.

9. Treatment with any of the following medications or interventions < 28 days prior to
Screening

10. Treatment with any investigational vaccine within 2 years prior to Screening, or
treatment with any other investigational product within 28 days prior to Screening

11. Any antibiotic therapy or infection within 1 week prior to Screening, including
unexplained fever (temperature ≥ 100.5F or 38.1C)

12. History of autoimmune disease

13. Serious ongoing chronic or acute illness

14. Any medical intervention or other condition which, in the opinion of the Principal
Investigator and/or the Bellicum Medical Monitor, could compromise adherence with
study requirements

Other Criteria Apply however are not listed