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

• Sponsor: Shenzhen Second People's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03685786
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 39.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Lymphocytic, Acute, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell	Biological: CART19 cell and auto-HSCT	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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).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).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Jun 1, 2018
• Anticipated Primary Completion Date: Jun 2, 2021
• Anticipated Study Completion Date: Sep 2, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weihong Chen	Shenzhen	Guangdong	China	518035

Sponsors and Collaborators

• Shenzhen Second People's Hospital

Investigators

• Principal Investigator: Weihong Chen, M.D., Ph.D., The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University
• Principal Investigator: Xin Du, M.D., Ph.D., The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University
• Principal Investigator: Xiaochun Wan, Ph.D., Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shenzhen Second People's Hospital
• ClinicalTrials.gov Identifier: NCT03685786
• Other Study ID Numbers: Weihong Chen06062018
• First Posted: Sep 26, 2018
• Last Update Posted: Dec 7, 2018
• Last Verified: Dec 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Lymphoma, B-Cell; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

No Results Posted as of Dec 7, 2018