Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia

This study is a multi-center, open-label, non-randomised, single-arm phaseⅠclinical trial to explore the safety and efficacy of FL-33 CAR T therapy for refractory/relapsed acute myeloid leukaemia. The primary endpoints are incidence and type of dose limiting toxicity within 21 days of CAR T infusion; total number, incidence and severity of adverse events (AE) 30 days after CAR T infusion. The secondary endpoints are total number, incidence and severity of AEs 30 days to 2 years after CAR T infusion; objective response rate (ORR), complete response rate (CR) and complete response with incomplet

Trial Details

NCT ID
NCT06326021
Phase
PHASE1
Sponsor
Beijing GoBroad Hospital
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • autologous FL-33 CAR T therapy
  • prior-HSCT donor-derived FL-33 CAR T therapy
  • Newly matched donor-derived FL-33 CAR T therapy
  • FL33-03 CAR-T therapy
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806
  • Chengdu, Sichuan, China|30.66667,104.06667
  • Beijing, China|39.9075,116.39723

Key Eligibility Criteria

  • Patients who met all the inclusion criteria were eligible for enrolment.
  • Patients diagnosed with primary resistance acute myeloid leukemia, tumour surface antigen CD33 expression, chemotherapy relapse, extramedullary rel…
  • Age 1-70 years old;
  • No severe allergies;

For full eligibility, visit ClinicalTrials.gov.

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