A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Gynecologic Cancer

Sponsor
Chongqing Precision Biotech Co., Ltd
Study ID
NCT06215950
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Cancer
  • Cervix Cancer
  • Gynecologic Cancer
  • Metastatic Cancer
  • Ovarian Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD70 CAR-T cells — BIOLOGICAL
    After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were transfused intravenically
  • CD70 CAR-T cells — BIOLOGICAL
    After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were injected intraperitoneally

Study Details

This is a single-center, double-arm, open-label study. this study plans to evaluate the safety and efficacy of CD70-targeting CAR-T cells in the treatment of CD70-positive advanced/metastatic Gynecologic Cancer, and obtain recommended doses and infusion patterns.

Key Dates

First listed
Jan 22, 2024
Start date
Jan 10, 2024
Status verified
Jan 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intravenous of CD70-targeted CAR-T
    Infusion of CD70-targeted CAR-T cells by dose of 1-10x10\^6 cells/kg
  • Experimental: intraperitoneal injection of CD70-targeted CAR-T
    Infusion of CD70-targeted CAR-T cells by dose of 1-10x10\^6 cells/kg

Primary Outcome Measure

Incidence of Adverse events after CD70 CAR-T cells infusion [Safety and Tolerability] [ Time Frame: 28 days ]

Central Contacts

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Ovarian cancer trialsOncology trialsGynecologic oncology trialsWomen's health trials

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