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PSMA-CART in Treating Patients With Refractory Castrate-Resistant Prostate Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04053062
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : August 14, 2019
Changhai Hospital
Information provided by (Responsible Party):
Shanghai Bioray Laboratory Inc.

Brief Summary:
This is a single center, single arm Phase I study to establish the safety and efficacy of intravenously administered lentivirally transduced PSMA-specific CAR modified autologous T cells (PSMA-CART cells) in patients with refractory CRPC.

Condition or disease Intervention/treatment Phase
Castrate-Resistant Prostate Cancer Biological: PSMA-CART cells Phase 1 Phase 2

Detailed Description:
This is a Phase I study evaluating the safety and efficacy of PSMA targeting autologous CAR T cells in a 3+3 dose escalation design. Cohort 1 subjects (N=3 or 6) will receive a single dose of 0.5-1x 10^7/kg body weight (KgBW) PSMA-CART cells on day 0 after a conditioning chemotherapeutic regimen(Cy+Flu). If 1 DLT/3 subjects occurs, the study will enroll an additional 3 subjects at this dose level. If 0 DLT/3 subjects or 1 DLT/6 subjects occurs, the study will advance to Cohort 2, with a single dose of 3-6 x 10^7/ KgBW.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Sequential Assignment
Intervention Model Description: 0.5-1 x 10^7/ KgBW; 3-6 x 10^7/ KgBW
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study to Evaluate the Safety and Efficacy of PSMA-CART in Treating Patients With Refractory Castrate-Resistant Prostate Cancer (CRPC)
Actual Study Start Date : August 8, 2019
Estimated Primary Completion Date : August 10, 2020
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: PSMA-CART
Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -6 to -4. Patients receive PSMA-specific CAR-expressing T lymphocytes IV over on day 0.
Biological: PSMA-CART cells
PSMA-CART cells will be given IV on day 0 over 20-30 mins
Other Name: Autologous PSMA-specific chimeric antigen cells

Primary Outcome Measures :
  1. 2. Incidence of toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: 35 days ]
    All adverse events (AEs) will be listed and summarized. Summaries of laboratory data will include, at a minimum, treatment-emergent laboratory abnormalities. Summaries of AEs and laboratory abnormalities will be based on the All Treated analysis set.

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 24 weeks ]
    Proportion of patients with a best response of either complete response or partial response, assessed using Prostate Cancer Working group(PCWG) response criteria.

  2. Duration time of CART cells in vivo [ Time Frame: 24 weeks ]
    Number of persistent PSMA-CART cells detected by Q-PCR or flow cytometry

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Fully understand and voluntarily sign informed consent.
  • Male, aged 18 to 75 years old.
  • Expected survival > 6 months.
  • CRPC patients: Prostate cancer is still progressing after continuous androgen deprivation therapy. Including, castrate levels of serum testosterone (<50ng/dl or <1.7nmol/L); or prostate specific antigen (PSA) increased more than 50% at intervals of one week or three consecutive times, and PSA>1 ug/L; or imaging scans revealed two or more new lesions or enlargement of soft tissue lesions that met the criteria for evaluating solid tumor response.
  • CRPC patients received abiraterone or chemotherapy for 3 months or more, and were ineffective or progressive (PSA continued to rise for 3 months, or bone scan/whole-body MRI/PET-CT showed local recurrence or new metastasis).
  • Immunohistochemical staining of repetitive biopsy tissues showed the expression of PSMA in tumor cells was more than 50%.
  • ECOG score <2.
  • Hgb > 10 g/dl.
  • PLT > 100×109/L.
  • ANC > 1.5×109/L.

Exclusion Criteria: Subjects who meet any of the following exclusion criteria will be excluded

  • Prior treatment with any immunotherapy, including CART therapy, tumor vaccine therapy, radium-223, checkpoint inhibitors.
  • Prior treatment with any PSMA targeting therapy.
  • Subjects with severe mental disorders.
  • Subjects with severe cardiovascular diseases: a, New York Heart Association (NYHA) stage III or IV congestive heart failure; b, history of myocardial infarction or coronary artery bypass grafting (CABG) within 6 months; c, clinical significance of ventricular arrhythmia, or history of unexplained syncope, non-vasovagal or dehydration; d, history of severe non-ischemic cardiomyopathy; e, the left ventricular ejection fraction (LVEF < 55%) was decreased by echocardiography or MUGA scan (within 8 weeks before PBMC collection), and abnormal interventricular septal thickness and atrioventricular size associated with myocardial amyloidosis.
  • Patients with ongoing or active infection.
  • Aspartate aminotransferase or Alanine aminotransferase >2.5*ULN;CK>*ULN; CK-MB>*ULN;TnT>1.5*ULN.
  • Total bilirubin > 1.5*ULN.
  • Partial prothrombin time or activated partial thromboplastin time or international standardized ratio > 1.5*ULN without anticoagulant treatment.
  • History of participation in other clinical studies within 3 months or treatment with any gene therapy product.
  • Intolerant or allergic to cyclophosphamide or fludarabine.
  • Subjects not appropriate to participate in this clinical study judged by investigators.

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): NCT04053062

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Contact: Wei Li, PhD +8618621670308

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China, Shanghai
Changhai Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Shancheng Ren, Professor         
Principal Investigator: Shancheng Ren, PhD         
Sponsors and Collaborators
Shanghai Bioray Laboratory Inc.
Changhai Hospital
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Principal Investigator: Shancheng Ren, Professor Changhai Hospital

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Responsible Party: Shanghai Bioray Laboratory Inc. Identifier: NCT04053062    
Other Study ID Numbers: 2018-CAR-00CH5
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Bioray Laboratory Inc.:
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases