Anti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia Clinical Trial

Official title:

Pilot Study of the Safety and Efficacy of Anti-CLL1 Chimeric Antigen Receptor Engineered T-Cells in the Treatment of CLL1 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04884984
• Other study ID #: UnicarTherapy2021001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2021
• Source: The First Affiliated Hospital of Soochow University
• Contact: Xiaowen Tang, Ph.D
• Phone: (0086)51267781856
• Email: xwtang1020[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of anti-CLL1 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CLL1 positive relapsed or refractory acute myeloid leukemia.

Description:

The patients will receive infusion of anti-CLL1 CAR T-cells to confirm the safety and efficacy of anti-CLL1 CAR T-cells in relapsed or refractory acute myeloid leukemia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

Inclusion Criteria:

• CLL1 positive relapsed/refractory acute myeloid leukemia
• Age 6-65 years
• Left ventricular ejection fractions = 0.5 by echocardiography
• Creatinine < 1.6 mg/dL
• Aspartate aminotransferase/aspartate aminotransferase < 3x upper limit of normal
• Total bilirubin <2.0 mg/dL
• Karnofsky performance status = 60
• Expected survival time = 3 months (according to investigator's judgement)

Exclusion Criteria:

• Patients are pregnant or lactating
• Uncontrolled active infection
• Class III/IV cardiovascular disability according to the New York Heart Association Classification
• Active hepatitis B or hepatitis C infection
• Patients with HIV infection
• Patients with history of seizure
• Active central nervous system leukemia

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• anti-CLL1 CART
Split intravenous infusion of anti-CLL1 CAR T cells [dose escalating infusion of (5-20)x10^6 anti-CLL1 CAR T cells/kg].

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events	Adverse events are evaluated with CTCAE V5.0	12 months
Secondary	Overall response rate (ORR)	ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.	2 years
Secondary	overall survival (OS)	The date of enrollment to the date of death from any cause	2 years
Secondary	Event-free survival (EFS)	Time from enrollment to the date of primary refractory disease, or relapse from CR or CRi, or death from any cause	2 years
Secondary	Cumulative incidence of relapse(CIR)	Time from the date of achievement of a remission to the date of relapse	2 years