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Clinical Trial 19802

Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT02744287

Phase: Phase I/II
Principal Investigator: Kim, Dae Won

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or 1-800-679-0775 Learn More

Overview

Study Title

A Phase 1/2 Feasibility And Safety Study Of PSCA-Specific Chimeric Antigen Receptor Engineered T Cells (BPX-601) In Subjects With Non-Resectable Pancreatic Cancer

Summary

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, stomach, 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.

Objective

Primary Objectives: To determine the safety and tolerability of BPX-601 cells administered in subjects with non-resectable pancreatic cancer. To assess the safety of the administration of the dimerizer drug, rimiducid, in subjects who have received BPX-601 cells. To determine the relationship between the administration of rimiducid and the persistence or activity of the BPX-601 T cells. To determine the maximum tolerated dose (MTD) and/or the recommended expansion dose level of BPX-601 in subjects with non-resectable pancreatic cancer.

Treatments

Therapies

Immunotherapy

Medications

BPX-601 (); Rimiducid ()

Inclusion Criteria

Each subject must sign and date an informed consent form

Histologically or cytologically confirmed diagnosis of one of the following:

Metastatic pancreatic ductal adenocarcinoma (PDAC) with disease progression within 6 months of the most recent anti-cancer treatment

Prior treatment with first or second-line therapy including targeted immunotherapy. Subjects eligible for approved targeted therapy based on MSI-H/dMMR status and/or gene profiling should have received such therapy as appropriate unless contraindicated. Subjects with mixed histology may be included if the predominant component is adenocarcinoma

Measurable disease (at least one target lesion) per RECIST v1.1 at Baseline

Documented positive tumor expression of PSCA as determined by central testing of an available, representative tissue specimen

Metastatic castration-resistant adenocarcinoma of the prostate (CRPC) defined as serum testosterone level > Progressive disease is defined by rising PSA or radiographic imaging according to the PCWG3 criteria (Scher 2016) during or following the direct prior line of therapy in the setting of medical or surgical castration

At least one prior chemotherapy regimen in the metastatic setting

Must have measurable disease by RECIST v1.1 at Baseline or bone only metastases with measurable PSA at Baseline

Prior therapy with at least one standard 17α lyase inhibitor or second-generation anti-androgen therapy for the treatment of castrate-resistant prostate cancer

Age >18 years

Life expectancy > 12 weeks

Agreement to consent to pretreatment as well as on treatment, fresh tumor biopsy where tissue collection is clinically feasible

ECOG performance status 0 or 1

Subjects must have adequate venous access for apheresis or agree to use of a central line for apheresis collection

Subject has adequate organ function defined by protocol

Female subject must be not of childbearing potential defined as:

Premenarchal; Postmenopausal (> 45 years of age with amenorrhea ≥ 12 months); Permanently sterilized; Otherwise incapable of pregnancy

Of childbearing potential and agrees to use 2 highly effective methods of birth control for at least 12 months after lymphodepletion

From the time of Screening/Study Treatment ICF signature, male subjects with female partners of childbearing potential must agree to use 2 highly effective methods of birth control from the time of Screening/Study Treatment ICF signature until at least 12 months after lymphodepletion

Exclusion Criteria

Pancreatic cancer subjects with: Islet cell neoplasms; Clinical or radiographic evidence of deep vein thrombosis, pulmonary embolism, or other known thromboembolic event that has not been definitely treated. Subjects with prior history of coagulopathy must be on low-molecular weight heparin prophylaxis and asymptomatic within 4 weeks of enrollment.

Prostate cancer subjects with: Structurally unstable bone lesions suggesting impending fracture; Clinical or radiographic evidence of deep vein thrombosis, pulmonary embolism, or another known thromboembolic event that has not been definitely treated. Subjects with prior history of coagulopathy must be asymptomatic within 4 weeks of enrollment.

History of >Grade 2 hematuria within the previous 6 months

Symptomatic, untreated, or actively progressing central nervous system metastases

Subjects with prior brain metastases treated at least 2 weeks prior to the planned infusion who are clinically stable and do not require chronic corticosteroid treatment are allowed

History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, or leptomeningeal disease.

Ongoing toxicities related to prior anticancer therapy that have not resolved to Grade 2 non-hematologic toxicity may be allowed following discussion with and approval by the Sponsor.

Participation in any investigational drug study within 4 weeks prior to enrollment.

Chemotherapy, targeted therapy, or radiotherapy (excluding palliative radiation) within 2 weeks or 5 half-lives, whichever is shorter, or immunotherapy within 4 weeks prior to enrollment

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 (such as Sipuleucel-T, PROSTVAC) are allowable. Immune checkpoint inhibitors, radium-223 and immunoconjugate therapies are also allowable pending discussion with the Sponsor.

Active autoimmune disease or any disease requiring immunosuppressive therapy. Subjects with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur, or history of Hashimoto's Thyroiditis on stable dose of thyroid hormone replacement therapy should not be excluded.

Impaired cardiac function or clinically significant cardiac disease, including any of the following:

Symptomatic congestive heart failure requiring treatment;

Clinically significant cardiac arrhythmia;

Uncontrolled hypertension;

Acute myocardial infarction or unstable angina pectoris within 3 months prior to enrollment;

Corrected QT interval (QTcF) > 480 msec; or, Marked limitation of physical activity due to symptoms, or unable to carry on any physical activity without discomfort

Major surgical procedure, other than for diagnosis, within 4 weeks prior enrollment, or anticipation of the need for a major surgical procedure during the study.

Received a vaccine containing live virus within 4 weeks prior to enrollment. Seasonal flu vaccines that do not contain live virus are permitted.

Treatment with systemic chronic steroid therapy (prednisone of > 10 mg/day or equivalent) within 7 days or 7 half-lives of the prescribed corticosteroid, whichever is shorter, prior to the planned apheresis date (refer to Appendix 5 on half-lives of common corticosteroids).

Uncontrolled intercurrent illness including but not limited to poorly controlled hypertension or diabetes, or any medical condition determined by the investigator to be a risk for enrolling on the protocol.

Other exclusion criteria will apply

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