Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors

  • Interventional
  • Recruiting
  • NCT02744287
Eligibility Details Visit Clinicaltrials.gov

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 (pancreatic and 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 (pancreatic or 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 (fixed dose of 0.4 mg/kg per infusion).

     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 pancreatic cancer with tumor progression within 6 months of the most recent anti-cancer treatment and documented positive tumor expression of PSCA, and prior treatment with first or second-line therapy; or,

         - 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:

         - Pancreatic cancer with islet cell neoplasms or symptomatic/untreated coagulopathy.

         - 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.

At a Glance

National Government IDNCT02744287

IRB#IRB21-0411

Lead SponsorBellicum Pharmaceuticals

Lead PhysicianWalter Stadler

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting