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NOT YET RECRUITING
NCT07897136
PHASE1

CLL-1/CD70 Dual-Target CAR-T Cell Therapy for Acute Myeloid Leukemia

Sponsor: Liping Dou

View on ClinicalTrials.gov

Summary

This is a single-center, open-label, single-arm, prospective, investigator-initiated dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of an autologous CLL-1/CD70 dual-target CAR-T cell injection in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML; acute promyelocytic leukemia excluded). After leukapheresis for CAR-T cell manufacture, participants receive lymphodepleting conditioning (fludarabine 30 mg/m\^2/day plus cyclophosphamide 300 mg/m\^2/day on Days -5 to -3), followed by a single intravenous infusion of CLL-1-CD70 CAR-T cells. Dose escalation follows a traditional 3+3 design with planned dose levels of 0.5 x 10\^6, 1 x 10\^6, and 2 x 10\^6 CAR-T cells/kg, guided by dose-limiting toxicities (DLTs) assessed during Days 1-28 after infusion. The primary endpoint is safety and tolerability, as assessed by treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematologic toxicity, organ toxicity, infections, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), and tumor lysis syndrome (TLS). Efficacy will be evaluated by the composite complete remission rate (CRc, defined as the proportion of patients achieving CR, CRh, or CRi) at prespecified time points according to the European LeukemiaNet (ELN) 2022 criteria, overall survival (OS), event-free survival (EFS), duration of response (DOR), and cumulative incidence of relapse (CIR) over a 1-year follow-up period. Immune reconstitution following CAR-T cell infusion will also be assessed at prespecified time points. CAR-T cellular kinetics in peripheral blood (CAR transgene copies, Cmax, Tmax, and AUC0-28d) will also be evaluated.

Official title: A Clinical Study on the Safety of Bispecific CLL-1-CD70 Dual-Target CAR-T Therapy for Acute Myeloid Leukemia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-11-30

Completion Date

2029-11-30

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

DRUG

CLL-1-CD70 CAR-T Cell Injection

CLL-1-CD70 CAR-T Cell Injection is an investigational autologous dual-target CAR T-cell therapy (lentiviral vector-based) directed against CLL-1 and CD70, for patients with relapsed or refractory (R/R) acute myeloid leukemia (acute promyelocytic leukemia excluded). After leukapheresis and lymphodepleting conditioning (fludarabine plus cyclophosphamide), participants receive a single intravenous infusion at protocol-specified dose levels (0.5 x 10\^6, 1 x 10\^6, or 2 x 10\^6 CAR-T cells/kg). Dose escalation follows a traditional 3+3 design and is guided by the occurrence of dose-limiting toxicities (DLTs).

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China