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

Lymphoma, B-Cell Clinical Trial

Official title:

The Study of Autologous T Cells Expressing CD19 Chimeric Antigen Receptors Treatment of Minimal Residual Disease(MRD) of B Cell Malignancies and Then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03685786
• Other study ID #: Weihong Chen06062018
• Status: Recruiting
• Phase: Phase 1
• Start date: June 1, 2018
• Est. completion date: September 2, 2021

Study information

• Verified date: December 2018
• Source: Shenzhen Second People's Hospital
• Contact: Weihong Chen, M.D., Ph.D.
• Phone: 0086-755-83366388
• Email: whitney-cindy[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2, 2021
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

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:

1. AST and ALT = 3 times upper limit of normal range for age,

2. Serum creatinine = 1.6 mg/dl,

3. Direct bilirubin =2.0 mg/dl,

4. Adequate pulmonary function defined as = grade 2 dyspnea and = grade 2 hypoxia,

5. 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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Acute, B-Cell
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma, B-Cell
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• CART19 cell and auto-HSCT
Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T (CART19) Cells treatment for Adult Patient with Minimal Residual Disease(MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT). Subjects will receive 0.5-4 x 10^8 transduced CAR T cells as a split dose over three days as follows:Day 0, 10% fraction: 0.5-4x10^7 CART19 cells, Day 1, 30% fraction: 1.5x10^7-1.2x10^8 CART19 cells, Day 2, 60% fraction: 3x10^7-2.4x10^8 CART19 cells. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.

Locations

Country	Name	City	State
China	Weihong Chen	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT	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	day 28