Allogeneic CART-33 for Relapsed/Refractory CD33+ AML

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33) infusions in patients with relapsed / refractory acute myeloid leukemia (AML).

Detailed Description
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The relapsed and/or refractory AML patients will receive infusions of allogeneic CART-33 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily idarubicin and cytarabine, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.

Official Title
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Treatment of Relapsed and/or Refractory CD33-positive Acute Myeloid Leukemia by Infusions of Allogeneic CART-33

Conditions
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Relapsed and/or Refractory CD33+ AML

Intervention / Treatment
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* Biological: allogeneic CART-33


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 50 years Patient with relapsed and/or refractory CD33 positive acute myeloid leukemia (AML) Estimated life expectancy ≥ 12 weeks (according to investigator's judgment) Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Exclusion Criteria: Previous treatment with investigational gene or cell therapy medicine products CD33 negative leukemia Any uncontrolled active medical disorder that would preclude participation as outlined Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: allogeneic CART-33<br>infusions of allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33) | Biological: allogeneic CART-33<br>* allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of study related adverse events | defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate of allogeneic CART-33 | A response is defined as: (1) a morphologic complete remission (CR) or (2) a complete remission with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2015) or (3) a negative minimal residual disease assessed by flow cytometry or qPCR | up to 24 weeks | 
| Disease-free survival |  | up to 24 weeks | 
| Overall survival |  | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CART, AML