Clinical trial NCT03685786: CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Leukemia, Lymphocytic, Acute, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19) treatment for the Patients with Minimal Residual Disease (MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT).
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
timeFrame: day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Weihong Chen
state: Guangdong
Study officials:
affiliation: The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University
name: Weihong Chen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University
name: Xin Du, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
name: Xiaochun Wan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou W, Chen W, Wan X, Luo C, Du X, Li X, Chen Q, Gao R, Zhang X, Xie M, Wang M. Benefits of Chimeric Antigen Receptor T-Cell Therapy for B-Cell Lymphoma. Front Genet. 2022 Jan 20;12:815679. doi: 10.3389/fgene.2021.815679. eCollection 2021.