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

NCT03891706 | Recruiting Phase 1 DMC

• 1 other identifier: FI-FIT001-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 .

Conditions

Solid Tumor

Keywords

TCR-T

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

  Keep records the adverse events experienced by subjects in 30 days after the last infusion.

  At least 45 days

Secondary Outcomes (3)

• Disease Control Rate(DCR)

  one year

• overall survival(OS)

  two year

• progression-free survival(PFS)

  two year

Study Arms (1)

TCR-T cell infusion

EXPERIMENTAL

Patient will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy

Drug: tumor-specific TCR-T cells; Drug: Interleukin-2

Interventions

tumor-specific TCR-T cells DRUG

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.

Also known as: TCR-T cells, FIT-001

TCR-T cell infusion

Interleukin-2 DRUG

Aldesleukin 3,000,000 IU. IV.QD beginning within 24 hours of cell infusion and continuing for up to 5 days .

Also known as: IL-2

TCR-T cell infusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 70 years old, regardless of gender;
• Diagnosed as solid tumors by histopathology, and the tumor lesions could be detected or evaluated;
• Be after standard treatment or who lack effective treatment programs;
• Patients and their families were willing to participate in the clinical trial and signed the informed consent;
• Physical status: ECOG score 0-1;
• Expected survival time \> 3 months;
• 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.
• 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;
• 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.
• During the whole study period, patients can regularly visit the enrolled research institutions for relevant detection, evaluation and management;
• The patient is not allowed to use any anti-tumor drugs or treatments for 4 weeks prior to the infusion of TCR-T cells;
• Patients' tumor lesions can be obtained by surgery or puncture, and tumor infiltrating T cells can be successfully isolated from the obtained tumor tissue;
• T cells in patients' peripheral blood can effectively proliferate and expand by at least 10 times in the Pre-culture;
• 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.

You may not qualify if:

• Any form of primary immunodeficiency disease (such as severe combined immunodeficiency disease);
• Experiencing moderate to severe infection or possible opportunistic infection;
• Patients with a history of autoimmunity (e.g., SLE, psoriasis, etc.);
• Acute systemic infection, coagulation dysfunction or other serious cardiopulmonary diseases;
• Patients who have is suffering a large amount of glucocorticoid or other immunosuppressive agents within 4 weeks;
• Be allergic to any drug used in this study;
• 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;
• Pregnant and lactating women, as well as male and female patients who could not cooperate with contraception during the study period.

Sponsors & Collaborators

• Guangzhou FineImmune Biotechnology Co., LTD.: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Gaungdong, 510700, China

RECRUITING

MeSH Terms

Interventions

Interleukin-2

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Penghui Zhou

  Guangzhou FineImmune Biotechnology Co., LTD.

  STUDY DIRECTOR

Central Study Contacts

Xuzhi Pan

CONTACT

86-20-87343135; panxzh@sysucc.org.cn

Haiping Liu

CONTACT

020-31605836; liuhp11@fineimmu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2019
• First Posted: March 27, 2019
• Study Start: January 8, 2019
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)