CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT

Phase 1

• Conditions: Leukemia, Lymphocytic, Acute, B-Cell; Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell
• Interventions: Biological: CART19 cell and auto-HSCT

• Registration Number: NCT03685786
• Lead Sponsor: Shenzhen Second People's Hospital

Brief Summary

The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT

Detailed Description

The clinical study of the chimeric antigen receptor T cells (CART Cells) treatment for minimal residual disease(MRD) of B Cell Malignancies and then autologous hematopoietic stem cell transplantation(auto-HSCT).

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-26
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-05
• Last Update Posted: 2018-12-07
• Primary Completion: 2021-06-02
• Study Completion: 2021-09-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients with CD19+, B cell Acute Lymphocytic Leukemia(B-ALL), B cell Chronic Lymphocytic Leukemia(B-CLL), B cell Lymphoma，who have 0.01%≤MRD<10% during upfront treatment 2. Patients must be within 12 months of initial B-ALL, B-CLL, B cell Lymphoma diagnosis 3. Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis 4. Age 14 years to 75 years 5. Adequate organ function defined as:

2. AST and ALT ≤ 3 times upper limit of normal range for age,

3. Serum creatinine ≤ 1.6 mg/dl,

4. Direct bilirubin ≤2.0 mg/dl,

5. Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia,

6. Cardiac Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA. 6. Patients with CNS disease will be eligible if CNS disease is responsive to therapy 7. Expression of CD19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood 8. Adequate performance status defined as ECOG Performance Status 0 or 1 9. Provides written informed consent 10. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol

Exclusion Criteria

1. Active, uncontrolled infection
2. Active hepatitis B or hepatitis C
3. HIV Infection
4. Class III/IV cardiovascular disability according to the New York Heart Association Classification
5. Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
6. Pregnant or nursing (lactating) women Patients with a known history or prior diagnosis of optic neuritis or other
7. immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: CART19 cell and auto-HSCT	CART19 cell and auto-HSCT	CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.

Primary Outcome Measures

Name	Time	Method
CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT	day 28	The incidence of conversion of minimal residual disease (MRD) to \<0.01% after CART19 therapy in patients with MRD of B Cell Malignancies during upfront treatment

Trial Locations

Locations (1)

Weihong Chen; 🇨🇳 Shenzhen, Guangdong, China