This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.
Sign informed consent before conducting any trial-related activities;
Age of 18-75 years old, male or female;
Patients with first-line treatment failure;
Measurable lesions according to RECIST1.1 criteria.
Patients who received major surgery, conventional chemotherapy, large area radiotherapy, immunotherapy or biological therapy within 4 weeks before entering the trial;
Known to produce allergic reactions to any component of the trial treatment;
no recovery from previous surgery or treatment-related adverse events to ≤ grade 2 CTCAE;
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.
Single group
Super1 TCR-T
Biological/VaccineAll 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.
DLT
Determining the dose-limiting toxicity (DLT) of Super1 TCR-T adoptive Immunotherapy
MDT
Determining the maximum Tolerated dose (MTD) of Super1 TCR-T adoptive Immunotherapy
ORR
Objective response rate,defined as the proportion of subjects with a confirmed PR or better best response
OS
overall survival，time from subject's treatment to death. Participants with no death recorded at the time of statistical analysis were censored at the time of the last follow-up. In cases of loss to follow-up, data were censored at the date of the last contact with the participant.
PFS
progression-free survival ，the time from the subject's treatment to the occurrence of PD or death from any cause, whichever occurred first. If no event (PD or death) occurred, the date of the last response assessment was the censored time for PFS.
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Guangzhou FineImmune Biotechnology Co., LTD.
Lead sponsor
Sun Yat-Sen University Cancer Center
Collaborator
