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

Sponsor
Guangzhou FineImmune Biotechnology Co., LTD.
Study ID
NCT06942143
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Super1 TCR-T — BIOLOGICAL
    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.

Study Details

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

Key Dates

First listed
Apr 24, 2025
Start date
May 22, 2025
Status verified
Apr 2025
Primary completion
Apr 25, 2027
Completion
Jun 25, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

DLT [ Time Frame: Up to 28 Days ]

Central Contacts

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