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Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00664196
Recruitment Status : Suspended (Funding)
First Posted : April 22, 2008
Last Update Posted : June 17, 2016
Information provided by (Responsible Party):
Roger Williams Medical Center

Brief Summary:
This study tests the safety and tolerability of autologous anti-PSMA gene-modified T cells (designer T cells) in hormone refractory prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Gene Modified T Cells Phase 1

Detailed Description:
The study creates autologous gene-modified T cells against prostate specific membrane antigen (PSMA, unrelated to PSA) (designer T cells) by ex vivo modification of patient T cells. T cells are collected by leukopheresis, transported to the RWMC cGMP Cell Manipulation Core and transduced with retrovirus containing a chimeric antigen receptor (CAR) that is expressed on the modified cells. This CAR links specificity of an antibody against PSMA with signaling domains of the T cell and redirects the recognition of the T cells to engage and kill prostate cancer cells anywhere in the body. These are administered at a dose of 10^10 with randomization to either low or moderate Interleukin 2 given by CI (continuous infusion) for one month following the T cell infusion. Subsequent subjects will receive 10^11 cells with Interleukin 2 at either low or moderate dose, in a non randomized manner, depending upon the outcome of the prior cohort. Prior to T cell infusion, all subjects will receive non-myeloablative (NMA) conditioning. This conditioning creates a "space" in the blood and marrow for engraftment of the infused cells to maintain of high level of anti-tumor effector T cells in the body. Each patient is treated with a single dose of T cells, without repeat dosing. Patients are followed for toxicity and response and pharmacokinetics-pharmacodynamics of the infused T cells. Patients are on-study for one-month after their T cell dose.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ia/Ib Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning
Study Start Date : April 2008
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Biological: Gene Modified T Cells
One time infusion Modified T-Cells given through a vein in the arm or a catheter over a 30-60 minute period.
Other Names:
  • Designer T-Cells
  • PSMA
  • Hormone Refractory

Primary Outcome Measures :
  1. Determine the safety of using modified T cells by documenting the type and severity of any side effects and establishing the Maximum Tolerated Dose (MTD) [ Time Frame: 1 Month ]

Secondary Outcome Measures :
  1. Tumor Response [ Time Frame: 1 Month ]
  2. Pharmacokinetics [ Time Frame: 1 Month ]
  3. Pharmacodynamics [ Time Frame: 1 Month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed diagnosis of prostate cancer
  2. Elevated PSA
  3. Life expectancy > 4 months
  4. Performance status 0-1
  5. ANC 1.0
  6. Platelets > 100,000
  7. Hemoglobin > 8.0
  8. Creatinine < 1.5mg/dl
  9. Direct Bilirubin < 1.5 mg/dl
  10. No evidence of CHF, CAD, cardiac arrhythmias, A-fib, A flutter, myocardial infarction.
  11. No serious, symptomatic obstructive or emphysematous lung disease
  12. No asthma requiring IV medication during last 12 months, no serious lung disease associated with dyspnea at normal activity levels, or at rest due to any cause, including cancer metastasis and pleural effusion
  13. Patients must have a biopsy able tumor, and be willing to undergo biopsy (Group 3 only)
  14. Patient is at least 18 years of age.

Exclusion Criteria:

  1. Serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic or allergic disease based on history, labs or physical exam
  2. Active clinical disease caused by CMV, Hepatitis B, or C, HIV, TB
  3. Cytotoxic and/or radiation therapy during last 4 weeks prior to entry
  4. Any concurrent malignancies
  5. Patient requires systemic steroids
  6. Patient has participated in prior investigational therapy
  7. Patient has prior exposure to mouse antibody
  8. Patient has had irradiation to whole pelvis or >25% marrow

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00664196

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United States, Rhode Island
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Roger Williams Medical Center
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Principal Investigator: Richard P Junghans, PhD, MD Roger Williams Hospital
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Responsible Party: Roger Williams Medical Center Identifier: NCT00664196    
Other Study ID Numbers: 595-04
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Keywords provided by Roger Williams Medical Center:
Prostate Cancer
T cells
Gene Transfer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs