Multi-CAR T Cell Therapy for Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:

Multi-center Phase I/II Clinical Trial of Multi-CAR T Cell Therapy for Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03222674
• Other study ID #: GIMI-IRB-17015
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 15, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2018
• Source: Shenzhen Geno-Immune Medical Institute
• Contact: Lung-Ji Chang
• Phone: 86-075586725195
• Email: c[@]szgimi.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multi-CAR T cell therapy targeting different AML surface antigens in patients with relapsed or refractory acute myeloid leukemia (AML). Another goal of the study is to learn more about the function of the multi-CAR T cells and their persistency in the patients.

Description:

Acute myeloid leukemia (AML) is a malignant disease characterized by the rapid growth of myeloblasts that build up in the bone marrow and interfere with the production of normal blood cells.

In this study, the patients' own T cells will be genetically modified with lentiviral vectors expressing chimeric antigen receptors. The multi-CAR T cells recognize specific molecules such as CD33, CD38, CD123, CD56, MucI, and CLL1, which are often found expressed on the surface of AML cells. The engineered CAR T cells will be infused into patients.

The purpose of this clinical study is to assess the feasibility, safety and efficacy of the multi-CAR T cell therapy against AML. Another goal of the study is to learn more about the function of the multi-CAR T cells and their persistency in the patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age older than 2 years.

2. CD33, CD38, CD56, CD123, MucI, and CLL1 expression can be identified in the malignant cells by immuno-histochemical staining or flow cytometry.

3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 2 months.

4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction = 50%, oxygen saturation = 90%, creatinine = 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 × upper limit of normal, total bilirubin = 2.0mg/dL.

5. Hgb=80g/L.

6. No cell separation contraindications.

7. Abilities to understand and the willingness to provide written informed consent.

Exclusion Criteria:

1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.

2. Active bacterial, fungal or viral infection not controlled by adequate treatment.

3. Known HIV or hepatitis B virus (HBV) infection.

4. Pregnant or nursing women may not participate.

5. History of glucocorticoid for systemic therapy within the week prior to entering the test.

6. Previously treatment with any gene therapy products.

7. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Related Conditions & MeSH terms

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

Intervention

Biological:
• Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells
Infusion of Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center	KunMing	Yunnan
China	Shenzhen Geno-immune Medical Institute	Shenzhen	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Shenzhen Geno-Immune Medical Institute	The Cancer Hospital of Yunnan,Kunming, Yunnan, China, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients with treatment related adverse effect	percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical labs and so on.	a year
Secondary	Anti tumor activity of fourth generation CAR-T cells in patients with relapsed or refractory AML	scale of CAR copies and leukemic cell burden (for efficacy)	a year