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Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors

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: NCT03891706
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Guangzhou FineImmune Biotechnology Co., LTD.

Brief Summary:

The primary purpose of this study is to evaluate the safety of the tumor-specific TCR-T cells in the treatment of advanced Solid Tumor .

The secondary purpose of this study is to preliminarily showed the effect of TCR-T cells in the treatment of advanced Solid Tumor .


Condition or disease Intervention/treatment Phase
Solid Tumor Drug: tumor-specific TCR-T cells Drug: Interleukin-2 Drug: Fludarabine Drug: Cyclophosphamide Phase 1

Detailed Description:
This study is an open, single-center, phase I clinical trial which is aim to evaluate the safety and tolerability of tumor-specific TCR-T cells. In this study, these TCR-T cells will be multiplied, or grown, in the laboratory.Subjects will received TCR-T cells infusions twice at day 0 and day 14, with the use of IL-2 for 5 consecutive days after every cell infusion. Before the cells infusion, Subjects also received Flu/Cy chemotherapy regimen before the first TCR-T cell infusion: Fludarabine 25mg/m2/ d-iv-d4 ~ -d3 4 days ,Cyclophosphamide 500mg/m2/ d-iv-d4 ~ -d3.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Single-center, Stage I Clinical Study of Individualized Tumor Specific TCR-T Cells in the Treatment of Advanced Solid Tumors.
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: TCR-T cell infusion
Patient will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy
Drug: tumor-specific TCR-T cells
On day 0 and day 14, 0.5-5x10^9 TCR-T cells will be infused intravenously (IV) over 1 hour,patients may choose to receive more cell infusions if they benefit from the treatment.
Other Names:
  • TCR-T cells
  • FIT-001

Drug: Interleukin-2
Aldesleukin 3,000,000 IU. IV.QD beginning within 24 hours of cell infusion and continuing for up to 5 days .
Other Name: IL-2

Drug: Fludarabine
Fludarabine 25mg/m2/ d.iv. -d4~ -d3 before the first cell infusion.
Other Name: Fludara

Drug: Cyclophosphamide
Cyclophosphamide 500mg/m2/ d.iv. -d4~ -d3 before the first cell infusion.
Other Name: Cytoxan




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: At least 45 days ]
    Keep records the adverse events experienced by subjects in 30 days after the last infusion.


Secondary Outcome Measures :
  1. Disease Control Rate(DCR) [ Time Frame: one year ]
    DCR is defined as the proportion of patients with tumor size reduction(CR,PR) and stable (SD) assessed by RECIST 1.1 and iRECIST

  2. overall survival(OS) [ Time Frame: two year ]
    The time from the first injection of Investigational Product until death

  3. progression-free survival(PFS) [ Time Frame: two year ]
    PFS is defined as the time from the first injection of Investigational Product until objective tumor progression or death, whichever occurs first.Assessed by RECIST 1.1 and iRECIST



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 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged between 18 and 70 years old, regardless of gender;
  2. Diagnosed as solid tumors by histopathology, and the tumor lesions could be detected or evaluated;
  3. Be after standard treatment or who lack effective treatment programs;
  4. Patients and their families were willing to participate in the clinical trial and signed the informed consent;
  5. Physical status: ECOG score 0-1;
  6. Expected survival time > 3 months;
  7. HIV antibody negative;Hepatitis b surface antigen negative;Hepatitis c antibody negative;The results of blood routine and coagulation were roughly normal, lymphocyte >0.8×10^9/L, hemoglobin >100g/L, and the pregnancy test of female patients with fertility potential was negative.
  8. Left ventricular ejection fraction 50% as indicated by cardiac ultrasound;Upper normal level of serum ALT/AST < 2.5 times;Serum creatinine 1.6mg/dl;Total bilirubin 1.5mg/dl, subject's total bilirubin < 3mg/dl except for Gilberts Syndrome;
  9. At least 4 weeks after the last systemic treatment, the patient's toxic and side effects must be restored to grade 1 or lower (except for alopecia or vitiligo).If the subject undergoes minor surgery within 3 weeks prior to enrollment, as long as all toxicity is recovered to level 1 or lower, the subject will meet the enrollment requirements.
  10. During the whole study period, patients can regularly visit the enrolled research institutions for relevant detection, evaluation and management;
  11. The patient is not allowed to use any anti-tumor drugs or treatments for 4 weeks prior to the infusion of TCR-T cells;
  12. Patients' tumor lesions can be obtained by surgery or puncture, and tumor infiltrating T cells can be successfully isolated from the obtained tumor tissue;
  13. T cells in patients' peripheral blood can effectively proliferate and expand by at least 10 times in the Pre-culture;
  14. The benefits of participating in the clinical trial outweigh the risks,which was evaluated by the researchers base on the status or condition of the patients.

Exclusion Criteria:

  1. Any form of primary immunodeficiency disease (such as severe combined immunodeficiency disease);
  2. Experiencing moderate to severe infection or possible opportunistic infection;
  3. Patients with a history of autoimmunity (e.g., SLE, psoriasis, etc.);
  4. Acute systemic infection, coagulation dysfunction or other serious cardiopulmonary diseases;
  5. Patients who have is suffering a large amount of glucocorticoid or other immunosuppressive agents within 4 weeks;
  6. Be allergic to any drug used in this study;
  7. Central nervous system metastases patients with clinically unstable or acute meningitis (except these clinically stable after treatment) Clinical stability needs to be met as follows: 4 weeks at least before the trial treatment, 1) no new brain lesion or no expanded of the original lesions confirmed by MRI); 2) no hormone therapy for at least 2 weeks; 3) neurological symptoms have returned to baseline;
  8. For patients who suffered grade 3-4 immune-related adverse reactions of major organs after they received the treatment of PD-1 / PD-L1 antibody;
  9. Have exposed to any gene therapy products previously;
  10. Pregnant and lactating women, as well as male and female patients who could not cooperate with contraception during the study period.

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): NCT03891706


Contacts
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Contact: Xuzhi Pan 86-20-87343135 panxzh@sysucc.org.cn
Contact: Haiping Liu 020-31605836 liuhp11@fineimmu.com

Locations
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China, Gaungdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Gaungdong, China, 510700
Contact: Xuzhi Pan    86-20-87343135    panxzh@sysucc.org.cn   
Principal Investigator: Xiaoshi Zhang, professor         
Sponsors and Collaborators
Guangzhou FineImmune Biotechnology Co., LTD.
Sun Yat-sen University
Investigators
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Study Director: Penghui Zhou Guangzhou FineImmune Biotechnology Co., LTD.
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Responsible Party: Guangzhou FineImmune Biotechnology Co., LTD.
ClinicalTrials.gov Identifier: NCT03891706    
Other Study ID Numbers: FI-FIT001-001
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: December 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 Guangzhou FineImmune Biotechnology Co., LTD.:
TCR-T
Additional relevant MeSH terms:
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Neoplasms
Cyclophosphamide
Fludarabine
Interleukin-2
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents