Clinical Study of Novel CAR-ITNK Cells Targeting CD70 and CLL1 for Refractory/Relapsed AML
ConditionR/R AML
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji Hospital
About this trial
The purpose of this clinical trial is to evaluate the safety and efficacy of CAR-ITNK cells therapy targeting CD70 and CLL1 in participants with relapsed/refractory Acute Myeloid Leukemia. Participants will receive a single infusion of CAR-ITNK cell therapy targeting CD70 and CLL1 and complete follow-ups over the next three years.
Eligibility criteria
Qualifiers
. Reappearance of leukemic cells in peripheral blood after achieving complete remission, or bone marrow blast count > 5% (excluding other causes such as bone marrow reconstitution post-consolidation chemotherapy), or the presence of extramedullary leukemic cell infiltration.
. Ineligible for bone marrow transplantation, or have undergone bone marrow transplantation but failed to achieve long-term remission.
. Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin ≤ 34.2 μmol/L.
. Kidney function: Creatinine clearance rate (Cockcroft-Gault method) ≥ 60 mL/min.
Disqualifiers
Women who are pregnant or breastfeeding.
Presence of uncontrolled fungal, bacterial, treponemal (e.g., syphilis), viral, or other infections.
Active hepatitis B (Hepatitis B virus DNA > 500 IU/mL) or a positive Hepatitis C virus RNA (HCV-RNA) test.
Human Immunodeficiency Virus (HIV) infection, or syphilis infection.
Trial design
Treatments tested in this trial
- CAR-ITNK Cells targeting CD70 and CLL1
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov