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Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas

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.
 
ClinicalTrials.gov Identifier: NCT03356782
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Lung-Ji Chang, 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 CAR T cells 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 CAR T cells and IgT cells to treat sarcoma.

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

Detailed Description:
Patients with late staged and/or recurrent sarcoma have poor prognosis despite complex multimodal therapy. Therefore, novel curative approaches are needed.This study will combine two different ways to fight sarcoma: antibodies and CAR-T cells. Several immune checkpoint antibodies have been examined on various tumors with good outcomes. Sarcoma is known to express increased levels of surface antigens that can be targeted by CAR-T cells. Thus, in this study, the 4SCAR-IgT cells targeting sarcoma surface antigens will be infused in dose escalation cohorts.This study will assess the feasibility, safety, efficacy and side effects of CAR T cells immunotherapy 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 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sarcoma-specific CAR-T cells
Peripheral blood mononuclear cells (PBMCs) of patients who have CD133, GD2, Muc1, CD117 or other marker positive sarcoma will be obtained through apheresis, and T cells will be activated and modified to sarcoma-specific CAR-T cells.
 Biological: Sarcoma-specific CAR-T cells
1 infusion, for 1x10^6~1x10^7 cells/kg via IV


Outcome Measures
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Primary Outcome Measures :
  1. Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events [ Time Frame: 3 months ]
    Physiological parameter (measuring cytokine response)


Secondary Outcome Measures :
  1. Persistence and proliferation of CART cells in patients [ Time Frame: 3 months ]
    The expansion and functional persistence of CART cells in the peripheral blood of patients will be measured by qPCR on Day 7, 14, 21, 28, 60 and 90 after infusion.


Other Outcome Measures:
  1. Anti-tumor effects [ Time Frame: 1 year ]
    Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.


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: ≥ 18 and ≤65 years of age at the time of enrollment;
  3. At least 4 weeks since any chemotherapy or radiotherapy and at least 1 week since immunosuppressive therapy such as using steroid hormone before enrollment;
  4. Side effects of chemotherapy have been well managed;
  5. Malignant cells are target antigen positive(higher than ++) confirmed by IHC, quantitative PCR or sequencing;
  6. Karnofsky /jansky score of 50% or greater;
  7. Expected survival > 6 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 autologous transduced T cells at levels greater than 15%;
  13. Sign an informed consent and assent.

Exclusion Criteria:

  1. The disease is progresseing rapidly;
  2. The patient is receiving therapy of other new drugs;
  3. Evidence of tumor potentially causing airway obstruction;
  4. Epilepsy history or other CNS diseases;
  5. Patients who need immunosuppressive drugs because of GVAD;
  6. History of long QT syndrome or severe heart diseases;
  7. Uncontrolled active infection;
  8. Active hepatitis B virus,hepatitis C virus and 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 would preclude participation as outlined;
  13. Pregnant or lactating women;
  14. Patients previously experienced toxicity from cyclophosphamide;
  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): NCT03356782


Contacts
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Contact: Lung-Ji Chang, PhD 86-075586725195 c@szgimi.org

Locations
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China, Guangdong
Shenzhen Geno-immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, PhD    86-075586725195    c@szgimi.org   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
Investigators
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Principal Investigator: Lung-Ji Chang, PhD Shenzhen Geno-Immune Medical Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lung-Ji Chang, President, Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT03356782    
Other Study ID Numbers: GIMI-IRB-17016
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: June 11, 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 Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute:
CART
PD-1
PDL-1
 CTLA-4
sarcoma
solid tumor
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