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Multi-CAR T Cell Therapy for Acute Myeloid Leukemia

Primary Purpose

Acute Myeloid Leukemia

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, CAR T, Muc1,CLL1, CD33, CD38, CD56, and/or CD123

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age older than 2 years.
CD33, CD38, CD56, CD123, MucI, and CLL1 expression can be identified in the malignant cells by immuno-histochemical staining or flow cytometry.
Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 2 months.
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.
Hgb≥80g/L.
No cell separation contraindications.
Abilities to understand and the willingness to provide written informed consent.

Exclusion Criteria:

Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
Active bacterial, fungal or viral infection not controlled by adequate treatment.
Known HIV or hepatitis B virus (HBV) infection.
Pregnant or nursing women may not participate.
History of glucocorticoid for systemic therapy within the week prior to entering the test.
Previously treatment with any gene therapy products.
Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Sites / Locations

Zhujiang Hospital of Southern Medical UniversityRecruiting
Shenzhen Geno-immune Medical InstituteRecruiting
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

CAR T cells to treat AML

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT03222674

First Posted

July 14, 2017

Last Updated

October 15, 2018

Sponsor

Shenzhen Geno-Immune Medical Institute

Collaborators

Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China, Yunnan Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03222674

Brief Title

Multi-CAR T Cell Therapy for Acute Myeloid Leukemia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 15, 2017 (Actual)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shenzhen Geno-Immune Medical Institute

Collaborators

Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China, Yunnan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

Keywords

AML, CAR T, Muc1,CLL1, CD33, CD38, CD56, and/or CD123

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Experimental

Arm Description

CAR T cells to treat AML

Intervention Type

Biological

Intervention Name(s)

Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells

Intervention Description

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

Primary Outcome Measure Information:

Title

percentage of patients with treatment related adverse effect

Description

percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical labs and so on.

Time Frame

a year

Secondary Outcome Measure Information:

Title

Anti tumor activity of fourth generation CAR-T cells in patients with relapsed or refractory AML

Description

scale of CAR copies and leukemic cell burden (for efficacy)

Time Frame

a year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age older than 2 years. CD33, CD38, CD56, CD123, MucI, and CLL1 expression can be identified in the malignant cells by immuno-histochemical staining or flow cytometry. Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 2 months. 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. Hgb≥80g/L. No cell separation contraindications. Abilities to understand and the willingness to provide written informed consent. Exclusion Criteria: Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. Active bacterial, fungal or viral infection not controlled by adequate treatment. Known HIV or hepatitis B virus (HBV) infection. Pregnant or nursing women may not participate. History of glucocorticoid for systemic therapy within the week prior to entering the test. Previously treatment with any gene therapy products. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lung-Ji Chang

Phone

86-075586725195

c@szgimi.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lung-Ji Chang

Organizational Affiliation

Shenzhen Geno-Immune Medical Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhujiang Hospital of Southern Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510282

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuhua Li, M.D, Ph.D

Phone

86-13533706656

liyuhua2011gz@163.com

First Name & Middle Initial & Last Name & Degree

Sanfang Tu, M.D, Ph.D

Phone

86-20-62782322

doctortutu@163.com

Facility Name

Shenzhen Geno-immune Medical Institute

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lung-Ji Chang, PhD

Phone

86-075586725195

c@szgimi.org

Facility Name

Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

City

KunMing

State/Province

Yunnan

ZIP/Postal Code

650000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xun Lai, MS

Phone

13577096609

1729112214@qq.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Multi-CAR T Cell Therapy for Acute Myeloid Leukemia

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