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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

CAR-ITNK Cells targeting CD70 and CLL1
Biological/Vaccine
Administer a single infusion of CAR-ITNK Cells targeting CD70 and CLL1 to this group of patients following fludarabine plus cyclophosphamide (F+C) lymphodepletion

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Experimental ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

ORR

The overall response rate (ORR) includes both complete response (CR) and partial response (PR), and uses the Clopper-Pearson method to calculate the two-sided 95% confidence interval.

Time frame

3 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: