OncoMatch/Clinical Trials/NCT07877610
CARCIK CD123/33 for Refractory/Relapsed AML and BPDCN in Children and Adults
Official title: Phase I/II Trial to Determine Safety and Efficacy of Non Viral Allogeneic Dual CD123/33 Chimeric Antigen Receptor CIK (CARCIK CD123/33) Cells in Adult and Pediatric Patients With Relapse/Refractory Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Is NCT07877610 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies CARCIK CD123/33 infusion for aml (acute myeloid leukemia).
Treatment: CARCIK CD123/33 infusion — The purpose of this phase I/II clinical trial is to test CARCIK-CD123/33 cells to treat patients with R/R AML/BPDCN, who have otherwise exhausted conventional treatment options. In particular, this study will assess the safety and feasibility of CARCIK-CD123/33 cells infusion in adults and children with R/R AML, ahead of scheduled alloHCT.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CD123 expression
Confirmed expression of CD123 and CD33 on leukemic blasts by flow cytometry
Required: CD33 expression
Confirmed expression of CD123 and CD33 on leukemic blasts by flow cytometry
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: systemic therapy
partial remission or refractory disease (including primary refractory) after two or more lines of therapy are eligible
Lab requirements
Kidney function
creatinine ≤1.5x ULN or CrCl ≥50 mL/min (adults, Cockroft-Gault); eGFR > 60 ml/min/1.73m2 (children, Schwartz formula)
Liver function
total bilirubin ≤ 2.0x ULN (≤ 3x ULN in patients with Gilbert's syndrome or documented liver involvement) and AST/ALT ≤ 5x ULN
Cardiac function
ejection fraction (EF) by ECHO or MUGA >40%
Adequate cardiac and pulmonary function: ejection fraction (EF) by ECHO or MUGA >40%; Adequate liver function: total bilirubin ≤ 2.0x ULN (≤ 3x ULN in patients with Gilbert's syndrome or documented liver involvement) and AST/ALT ≤ 5x ULN; Adequate renal function: creatinine ≤1.5x ULN or CrCl ≥50 mL/min (adults, Cockroft-Gault); eGFR > 60 ml/min/1.73m2 (children, Schwartz formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07877610 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy.
Does this trial require CD123?
Yes, CD123 expression is a required biomarker for enrollment.
Does this trial require CD33?
Yes, CD33 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger and at least 0 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages