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Trial record 1 of 1 for:    NCT04433221
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Combination Immunotherapy Targeting Sarcomas

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ClinicalTrials.gov Identifier: NCT04433221
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Collaborators:
The Seventh Affiliated Hospital of Sun Yat-sen University
Shenzhen Children's Hospital
Information provided by (Responsible Party):
Shenzhen Geno-Immune Medical Institute

Study Description
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Brief Summary:
The aim of this clinical trial is to assess the feasibility, safety and efficacy of a combination low dose chemotherapy and immunotherapy in patients who have sarcoma that is relapsed or late staged. Another goal of the study is to assess the safety and efficacy of the therapy that combines multiple CAR T cells followed by sarcoma vaccines.

Condition or disease Intervention/treatment Phase
Sarcoma Osteoid Sarcoma Ewing Sarcoma Biological: Multiple sarcoma-specific CAR-T cells and sarcoma vaccines Phase 1 Phase 2

Detailed Description:
Patients with late staged and/or recurrent sarcoma have poor prognosis despite complex multimodal therapy. Therefore, innovative interventions are needed. Sarcoma is known to express increased levels of surface antigens that can be targeted by CAR-T cells. In addition, studies have shown that low dose chemotherapy such as doxorubicin may modulate surface PD-L1 level and enhance immunotherapy effects. This study will combine multiple CAR T cells with low dose chemotherapy to treat sarcoma, and followed by maintenance sarcoma vaccines. The purpose of this clinical trial will assess the feasibility, safety, efficacy and side effects of this combination therapy in patients who have sarcoma that is relapsed or late staged.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Evaluation of a Combination Immunotherapy Targeting Sarcomas
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : December 31, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Multiple sarcoma-specific CAR-T cells
Patients who have confirmed surface antigens including GD2, PSMA, Her2, CD276 or other markers
 Biological: Multiple sarcoma-specific CAR-T cells and sarcoma vaccines
1 infusion, CART 1x10^6~1x10^7 cells/kg via IV and vaccines 1-5x10^6 irradiated cells via subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Safety of CART cells infusion [ Time Frame: 3 months ]
    Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events


Secondary Outcome Measures :
  1. Overall survival Rate [ Time Frame: 1 year ]
    Percentage of participants with objective response as determined by the investigator based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)

  2. Treatment response rate of sarcomas [ Time Frame: 1 year ]
    Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on CT imaging analysis.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Stage Ⅲ，Ⅳ sarcoma patients or recurrent sarcoma patients;
  2. Age: ≥ 6 months and ≤80 years of age at the time of enrollment;
  3. At least 2 weeks since the last standard chemotherapy or radiotherapy and immunosuppressive therapy such as steroid hormone before enrollment;
  4. Side effects of chemotherapy have been well managed;
  5. Confirmed malignant cell expression of CART target antigens by IHC or flow
  6. Karnofsky /jansky score of 50% or greater;
  7. Expected survival > 8 weeks;
  8. ANC≥ 1×10^6/L，PLT ≥ 1×10^8/L;
  9. Pulse oximetry of≥90% on room air；
  10. Adequate hepatic function, defined as aspartate aminotransferase(AST)< 5 times upper limit of normal(ULN),serum bilirubin < 3 times ULN;
  11. Adequate renal function, defined as serum creatinine less than 2 times ULN, if serum creatinine more than 1.5 times ULN, creatinine clearance rate test is needed;
  12. Patients must have sufficient autologous CART cells at does greater than 0.5x10^6 cells/kg body weight;
  13. Sign an informed consent and assent.

Exclusion Criteria:

  1. The disease is progressing rapidly;
  2. The patient is receiving therapy of other new drugs and under evaluation;
  3. Evidence of tumor potentially causing airway obstruction;
  4. Epilepsy history or other CNS diseases;
  5. Patients who need immunosuppressive drugs;
  6. History of long QT syndrome or severe heart diseases;
  7. Uncontrolled active infection;
  8. Active hepatitis B virus, hepatitis C virus or HIV infection;
  9. Receiving systemic corticosteroid 2 weeks before enrollment except for inhaled steroids;
  10. Previous treatment with any gene therapy;
  11. Creatinine>2.5mg/dl or ALT/AST>3 times normal or bilirubin>2.0 mg/dl;
  12. Patients who have other uncontrolled diseases such as obstruction of lung function would preclude participation as outlined;
  13. Pregnant or lactating women;
  14. Patients previously experienced toxicity from cyclophosphamide and doxorubicin;
  15. Patients who have CNS sarcoma;
  16. In condition that may bring risks to subjects or interference to clinical trials.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04433221


Contacts
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Contact: Lung-Ji Chang, MD 86-(0755)86725195 c@szgimi.org

Locations
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China, Guangdong
Shenzhen Children's Hospital Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Xiuli Yuan, MD    86-18938690212    18938690212@163.com   
The Seventh Affilliated Hospital, Sun Yat-Sen University Recruiting
Shenzhen, Guangdong, China, 518107
Contact: Bo Wang, MD    86-0755-23242570    wangb68377@sina.com   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
The Seventh Affiliated Hospital of Sun Yat-sen University
Shenzhen Children's Hospital
More Information
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Responsible Party: Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT04433221    
Other Study ID Numbers: GIMI-IRB-20007
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Shenzhen Geno-Immune Medical Institute:
Sarcoma
Chemotherapy
Doxorubicin
CART
Vaccine
Additional relevant MeSH terms:
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Sarcoma
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Neoplasms
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue