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A Clinical Study on the Safety of Bispecific CLL-1-CD70 Dual-Target CAR-T Therapy for Acute Myeloid Leukemia
Sponsor study identifier
interventional
12
1 country
1
Study Start
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 13, 2026
Actual (reported)October 27, 2026
Actual (reported)November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Safety: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Number of participants with at least one TEAE following CLL-1/CD70 CAR-T cell infusion, regardless of its relationship to treatment. TEAEs are adverse events that newly occur or worsen after infusion and include serious and non-serious events. Each participant will be counted once, irrespective of the number or type of TEAEs. Severity will be graded using NCI CTCAE v5.0, except that cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded using the ASTCT consensus criteria. Abnormal laboratory, vital sign, physical examination, and electrocardiogram findings will be included when they meet the protocol-defined adverse event criteria.
From CAR-T cell infusion through 12 months after infusion.
Composite Complete Remission Rate (CRc)
At Months 1, 3, 6, 9, and 12 after CAR-T cell infusion.
After leukapheresis and lymphodepleting conditioning (fludarabine 30 mg/m\^2/day plus cyclophosphamide 300 mg/m\^2/day on Days -5 to -3), participants receive a single intravenous infusion of CLL-1-CD70 CAR-T Cell Injection at one of three planned dose levels (0.5 x 10\^6, 1 x 10\^6, or 2 x 10\^6 CAR-T cells/kg) assigned by a traditional 3+3 dose-escalation design.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Liping Dou, Dr.
Chinese PLA General Hospital
First Submitted
October 13, 2026
First Posted
October 27, 2026
Study Start
November 30, 2026
EstimatedComplete Remission (CR) Rate
At Months 1, 3, 6, 9, and 12 after CAR-T cell infusion.
Complete Remission With Partial Hematologic Recovery (CRh) Rate
At Months 1, 3, 6, 9, and 12 after CAR-T cell infusion.
Complete Remission With Incomplete Hematologic Recovery (CRi) Rate
At Months 1, 3, 6, 9, and 12 after CAR-T cell infusion.
No Response (NR) Rate
At Months 1, 3, 6, 9, and 12 after CAR-T cell infusion.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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