Active — Not RecruitingEarly Phase 1

Clinical Study on the Safety and Efficacy of CAR-T/CAR-NK Cells in the Treatment of Recurrent Refractory or Unresectable Solid Tumors

China10 participantsStarted 2024-03-21

Plain-language summary

To investigate the safety and efficacy of CAR-T/CAR-NK cells in patients with recurrent or unresectable solid tumors, including pancreatic cancer, prostate cancer, breast cancer, glioma, etc

Who can participate

Age range15 Years – 80 Years

SexALL

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Inclusion criteria

✓. Recurrent or unresectable solid tumors (including pancreatic, prostate, breast, glioma, etc.).
✓. Age over 15 and under 80.
✓. KPS≥50 or ECOG score ≤2 and expected survival greater than 3 months.
✓. No systemic therapy (except systemic immune checkpoint suppression or activation therapy) for at least 2 weeks or at least 5 drug half-lives (whichever is shorter) prior to apheresis.
✓. The absolute number of neutrophils was \> 1.0x109 /L.
✓. Absolute number of platelets \> 50x109 /L.
✓. Absolute number of lymphocytes ≥ 0.2x109 /L.
✓. ALT/AST \< 3 times normal value.

What they're measuring

ORR

Timeframe: 2024.11

PFS

Timeframe: 2024.11

Trial details

NCT IDNCT06572956

SponsorThe Second Hospital of Shandong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01

View on ClinicalTrials.gov More Safety and Efficacy of Cellular Drugs, Objective Response Rate of Subjects, Etc trials