Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors
- Interventional
- Recruiting
- NCT02744287
Contact Information
A Phase 1/2 Feasibility, Safety, and Activity Study of PSCA-Specific Chimeric Antigen Receptor Engineered T Cells (BPX-601) in Subjects With Previously Treated Advanced Solid Tumors
The purpose of this study is to evaluate the safety and activity of BPX-601 CAR-T cells in participants with previously treated advanced solid tumors (prostate) expressing high levels of prostate stem cell antigen (PSCA). Participants' T cells are modified to recognize and target the PSCA tumor marker on cancer cells.
The goal of this study is to characterize the feasibility, safety, and clinical activity of
PSCA-specific CAR-T cells, BPX-601, administered with rimiducid to subjects with previously
treated, PSCA-positive advanced solid tumors (prostate). BPX-601 CAR-T cells are genetically
engineered to express a chimeric antigen receptor (CAR) to target the PSCA antigen and a
rimiducid-inducible signaling domain which functions as a molecular "go-switch" to enhance
activation and proliferation.
Phase 1: Cell dose escalation to identify the maximum dose of BPX-601 administered with single or repeat doses of rimiducid.
Phase 2: Indication-specific dose expansion to assess the safety, pharmacodynamics (including BPX-601 persistence), and clinical activity at the recommended dose identified in Phase 1 in various PSCA-expressing solid tumors.
Phase 1: Cell dose escalation to identify the maximum dose of BPX-601 administered with single or repeat doses of rimiducid.
Phase 2: Indication-specific dose expansion to assess the safety, pharmacodynamics (including BPX-601 persistence), and clinical activity at the recommended dose identified in Phase 1 in various PSCA-expressing solid tumors.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
Inclusion Criteria:
- Metastatic castration-resistant prostate cancer (mCRPC), with progressive disease per PCWG3 criteria during or following the direct prior line of therapy.
- Measurable disease per RECIST v1.1 at baseline; subjects with mCRPC with bone only metastases must have measurable PSA.
- Age ≥18 years.
- Life expectancy > 12 weeks.
- ECOG 0-1
- Adequate organ function.
Exclusion Criteria:
- Prostate cancer with unstable bone lesions or symptomatic/untreated coagulopathy, or history of > Grade 2 hematuria within the previous 6 months.
- Prior CAR T cell or other genetically-modified T cell therapy. Prior treatment with an immune-based therapy for the treatment of prostate cancer, including cancer vaccine therapies are allowable.
- Symptomatic, untreated, or actively progressing central nervous system metastases.
- Impaired cardiac function or clinically significant cardiac disease.
- Pregnant or breastfeeding.
- Participant requires chronic, systemic steroid therapy.
- Severe intercurrent infection.
- Known HIV positivity.
- Metastatic castration-resistant prostate cancer (mCRPC), with progressive disease per PCWG3 criteria during or following the direct prior line of therapy.
- Measurable disease per RECIST v1.1 at baseline; subjects with mCRPC with bone only metastases must have measurable PSA.
- Age ≥18 years.
- Life expectancy > 12 weeks.
- ECOG 0-1
- Adequate organ function.
Exclusion Criteria:
- Prostate cancer with unstable bone lesions or symptomatic/untreated coagulopathy, or history of > Grade 2 hematuria within the previous 6 months.
- Prior CAR T cell or other genetically-modified T cell therapy. Prior treatment with an immune-based therapy for the treatment of prostate cancer, including cancer vaccine therapies are allowable.
- Symptomatic, untreated, or actively progressing central nervous system metastases.
- Impaired cardiac function or clinically significant cardiac disease.
- Pregnant or breastfeeding.
- Participant requires chronic, systemic steroid therapy.
- Severe intercurrent infection.
- Known HIV positivity.