Single-center, Open-Label, Non-randomized, Single-Arm Phase 1 Study to Evaluate the Safety and Tolerability of Optimized Dual CD33/CLL1 CAR T Cells in Subjects With Refractory or Relapsed Acute Myeloid Leukemia

Beijing Boren Hospital1 site in 1 country20 target enrollmentFebruary 16, 2022

ConditionsAcute Myeloid Leukemia

InterventionsDual CD33/CLL1 CAR T

DrugsDual CD33/CLL1 CAR T

Overview

Phase: Phase 1
Intervention: Dual CD33/CLL1 CAR T
Conditions: Acute Myeloid Leukemia
Sponsor: Beijing Boren Hospital
Enrollment: 20
Locations: 1
Primary Endpoint: Incidence and severity of adverse events (AE)
Status: Withdrawn
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-center, open-label, non-randomized, single-arm Phase 1 Study to evaluate safety and tolerability of optimized Dual CD33/CLL1 CAR T Cells in subjects with refractory or relapsed acute myeloid leukemia. Maximum of twenty subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion chemotherapy (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day) will be administrated for 3 days.

Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 5×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) /kg.

Registry

clinicaltrials.gov

Start Date

February 16, 2022

End Date

December 31, 2023

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing Boren Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•In order to be eligible to participate in this study, an individual must meet all of the following criteria:
•Co-expression of tumor surface antigens CD33 and CLL1 was confirmed (among which, the proportion of cells expressing CD33 was ≥ 80%; and the proportion of cells expressing CLL1 ≥ 80%); patients with primary drug resistance, chemotherapy relapse, extramedullary relapse, persistent residual disease positive or relapsed/refractory acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation;
•Male or female, aged 1-70 years;
•No serious allergic constitution;
•Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2;
•Have life expectancy of at least 60 days based on investigator's judgement;
•Provide a signed informed consent before any screening procedure; subjects who voluntarily participate in the study should have the ability to understand and sign the informed consent form and be willing to follow the study visit schedule and relevant study procedure, as specified in the protocol. Candidates aged 19-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form; Children candidates of 8-18 years old need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form and their legal guardian or patient advocate has also need to sign the treatment consent form and voluntary consent form, respectively.Children candidates of 1-7 can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form.

Exclusion Criteria

•An individual who meets any of the following criteria will be excluded from participation in this study:
•Intracranial hypertension or disorder of consciousness;
•Symptomatic heart failure or severe arrhythmia;
•Symptoms of severe respiratory failure;
•Complicated with other types of malignant tumors;
•Diffuse intravascular coagulation;
•Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value;
•Suffering from septicemia or other uncontrollable infections;
•Patients with uncontrollable diabetes;
•Severe mental disorders;