An Open-label, Phase I Clinical Trial of Super1 TCR-T in NY-ESO-1-positive Patients With Advanced Solid Tumors

Study Purpose

This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Sign informed consent before conducting any trial-related activities; 2. Age of 18-75 years old, male or female; 3. Patients with first-line treatment failure; 4. Measurable lesions according to RECIST1.1 criteria. 5. During the trial screening period, the following two screening criteria must be met (by the sponsor) :
  • - HLA-A*02 positive; - The positive rate of NYESO-1 immunohistochemical staining was ≥20%.
6. ECOG score 0-1; 7. The expected survival time is more than 3 months; 8. Antineoplastic drugs and treatments were not allowed for 4 weeks before TCR-T cell infusion; 9. Echocardiography showed left ventricular ejection fraction ≥50%; 10. Laboratory test results should at least meet the following specified indicators:
  • - WBC ≥3.0×109/L; - Absolute neutrophil count (ANC) ≥1.5×109/L; - Absolute lymphocyte count (ALC) ≥1.0×109/L; - platelet (PLT) ≥75×109/L; - hemoglobin ≥10g/dL (no blood transfusion in the past 7 days); - Prothrombin time or INR≤1.5x upper limit of normal unless receiving anticoagulant therapy; - Partial prothrombin time (APTT) ≤1.5x upper limit of normal time, unless receiving anticoagulant therapy; - 24-hour creatinine clearance ≥60mL/ min; - Aspartate aminotransferase (AST/SGOT) ≤2.5×ULN; - alanine aminotransferase (ALT/SGPT) ≤2.5×ULN; - Total bilirubin (TBIL) ≤1.5×ULN.
11. Negative pregnancy tests in women of childbearing potential prior to study treatment; Consent must be given to use effective contraception during treatment. 12. During the whole period of the trial, I can regularly visit the enrolled research institutions for relevant testing, evaluation and management.

Exclusion Criteria:

1. Patients who received major surgery, conventional chemotherapy, large area radiotherapy, immunotherapy or biological therapy within 4 weeks before entering the trial; 2. Known to produce allergic reactions to any component of the trial treatment; 3. no recovery from previous surgery or treatment-related adverse events to ≤ grade 2 CTCAE; 4. Poorly controlled hypertension (systolic blood pressure > 160mmHg and/or diastolic blood pressure > 90mmHg) or clinically significant (e.g., active) cardio-cerebrovascular disease; Cerebrovascular accident (within 6 months before the signing of informed consent), myocardial infarction (within 6 months before the signing of informed consent), unstable angina, congestive heart failure of New York Heart Association class II or higher (Appendix), or severe arrhythmia that could not be controlled with medications or that had the potential to affect study treatment; Electrocardiogram (ECG) was significantly abnormal or the mean QTc interval was ≥450 msec on three consecutive occasions. 5. Combined with other serious organic diseases and mental disorders; 6. Have active systemic infection requiring treatment, including active tuberculosis, known HIV positivity, or clinically active hepatitis A, B, or C; (Virus carriers should be excluded) 7. Patients with autoimmune diseases: those with a history of inflammatory bowel disease or a history of autoimmune diseases (such as systemic lupus erythematosus, vasculitis, and invasive lung disease) judged by the investigators to be not suitable for this study should be excluded; (Patients with vitiligo are not excluded). 8. Administration of chronic systemic cortisone steroids, hydroxyurea, and immunomodulatory agents (e.g., interleukin-2, interferon-α or γ, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.) within 4 weeks prior to cell therapy." 9. History of organ transplantation, autologous/allogeneic stem cell transplantation and renal replacement therapy; 10. Known uncontrolled diabetes mellitus, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure; 11. Known alcohol and/or drug abuse; 12. Pregnant or lactating women; 13. Trial participants with any coexisting medical conditions or diseases judged by the investigators to be likely to impair the conduct of the trial; 14. No legal capacity/limited capacity.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06942143
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Guangzhou FineImmune Biotechnology Co., LTD.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Sarcoma, Lung Cancers, Melanoma
Additional Details

After the subjects signed the informed consent form, the HLA genotype of the subjects was detected. After the HLA genotype was confirmed as A*02, the tumor tissue was detected by immunohistochemistry. The subjects could proceed to the subsequent clinical trial if the NY-ESO-1 immunohistochemistry was positive. Each subject received only one cell reinfusion.

Arms & Interventions

Arms

Experimental: Dose escalation was performed in a 3+3 design

The Super1 TCR-T dose toxicity test was escalated according to the following dose (positive cells) escalation schedule: Level 1 Level 2 Level 3

Interventions

Biological: - Super1 TCR-T

All participators received lymphoid-depleted preconditioning before Super1 TCR-T cells infusion. Super1 TCR-T cells were infused 3 days later. Concomitant administration of interleukin for 7 consecutive days.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sun Yat-sen University Cancer Center, Guangzhou, Gaungdong, China

Status

Address

Sun Yat-sen University Cancer Center

Guangzhou, Gaungdong, 510700

Site Contact

Xing Zhang, Professor

[email protected]

020-87343629

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