PHASE I STUDY OF PSMA-TGFβRDN CAR MODIFIED T CELLS IN PATIENTS WITH ADVANCED CASTRATE RESISTANT PROSTATE CANCER


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03089203

Sponsor: University of Pennsylvania

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Metastatic castrate resistant prostate cancer ≥10% tumor cells expressing PSMA as demonstrated by immunohistochemistry analysis on fresh tissue.
  • Radiographic evidence of osseous metastatic disease and/or measurable, non-osseous metastatic disease (nodal or visceral)
  • Patients > 18 years of age
  • ECOG performance status of 0
  • 1
  • Adequate organ function, as defined by:
  • Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 cc/min
  • Serum total bilirubin < 1.5x ULN
  • Serum ALT/AST < 2x ULN
  • Adequate hematologic reserve within 4 weeks of study enrollment as defined by:
  • Hgb > 10 g/dl
  • PLT > 100 k/ul
  • ANC > 1.5 k/ul
  • Note: Subjects must not be transfusion dependent
  • Evidence of progressive castrate resistant prostate adenocarcinoma, as defined by:
  • Castrate levels of testosterone (< 50 ng/ml) with or without the use of androgen deprivation therapy AND
  • Evidence of one of the following measures of progressive disease in the 12 weeks preceding study enrollment: soft tissue progression by RECIST 1.1 criteria, osseous disease progression with 2 or more new lesions on bone scan(as per PCWG2 criteria), increase in serum PSA of at least 25% and an absolute increase of 2ng/ml or more from nadir (as per PCWG2 criteria)
  • Prior therapy with at least one standard 17α lyase inhibitor or second-generation anti-androgen therapy for the treatment of metastatic castrate resistant prostate cancer
  • Provides written informed consent
  • Subjects of reproductive potential must agree to use acceptable birth control methods

Exclusion Criteria:

  • Prior treatment with an immune-based therapy for the treatment of prostate cancer, including cancer vaccine therapies (such as SipuleucelT, PROSTVAC), immune checkpoint inhibitors,radium-223 and immunoconjugate therapies
  • History of an active non-curative non-prostate primary malignancy within the prior 5 years
  • Subjects with a rising PSA, but who have never had radiologic evidence of metastatic disease(i.e. 'biochemical recurrence')
  • Subjects who require the chronic use of systemic corticosteroid therapy
  • Subjects who have received > 3 prior therapies for the treatment of castrate resistant prostate cancer (excluding luteinizing hormone-releasing hormone agonists or antagonists, or first generation anti-androgen therapies). This includes subjects who received Taxotere in noncastrate setting.
  • Subjects with Class III/IV cardiovascular disability according to the New York Heart Association Classification
  • Subjects with symptomatic vertebral metastases affecting spinal cord function (as determined by clinical history, physical exam, or MRI imaging)
  • History of active autoimmune disease requiring immunosuppressive therapy
  • Patients with ongoing or active infection.
  • History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO,and Dextran 40)
  • Active hepatitis B, hepatitis C or HIV infection.

View trial on ClinicalTrials.gov