The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).

B-cell Acute Lymphoblastic Leukemia Clinical Trial

Official title:

The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Acute Lymphoblastic Leukemia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02924753
• Other study ID #: HenanCH080
• Status: Recruiting
• Phase: Phase 1
• First received: September 29, 2016
• Last updated: December 28, 2017
• Start date: July 18, 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2017
• Source: Henan Cancer Hospital
• Contact: Yongping Song
• Email: ph200811[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-ALL.

Description:

Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase,. Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for CART-19 manufacturing. The T cells will be purified from the PBMC, transduced with CART-19 lentiviral vector, expanded in vitro and then administered to subjects.

Subjects will have blood tests to assess safety and efficacy, and persistence of the CART-19 cells at regular intervals through four weeks after their last infusion of the study. Following the 6 months of intensive follow-up, subjects will be evaluated quarterly for two years with a physical examination, blood tests, bone marrow aspirate, minimal residual disease (MRD) and persistence of CART-19. Following this evaluation, subjects will be evaluated health problems every year for an additional thirteen years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 4 years to 70 years, expected survival > 3 months

2. CD19 positive B-cell acute lymphoblastic leukemia

3. Karnofsky Performance Status (KPS) >70

4. Relapsed after allogeneic or autologous stem cell transplantation (SCT);

5. Cardiac function: 1-2 levels; Liver: TBIL=3 Upper Limit of Normal (ULN),aspartate aminotransferase (AST) =2.5 ULN,ALT =2.5 ULN; kidney: Cr=1.25 ULN; bone marrow: White Blood Cell (WBC) = 3.0×109/L, Hb =90 g/L, Platelet (PLT) = 80×109/L)

6. No serious allergic constitution

7. No other serous diseases that conflicts with the clinical program

8. No other cancer history

9. No serious mental disorder

10. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

1. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)

2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive

3. Active hepatitis B or hepatitis C infection

4. Recent or current use of glucocorticoid or other immunosuppressor

5. With severe cardiac, liver, renal insufficiency, diabetes and other diseases

6. Transaminase >2.5 ULN, Bilirubin >3 ULN,Creatinine>1.25 ULN

7. Participate in other clinical research in the past three months; previously treatment with any gene therapy products

8. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• Burkitt Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Cyclophosphamide
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).
• Fludarabine
Fludarabine 25mg/m2/day IV for 3 days (Day-5 to day-3).

Biological:
• CART-19 cells
CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Henan Cancer Hospital	The Beijing Pregene Science and Technology Company, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety as assessed by the occurrence of study related adverse events.	monitor the occurrence of study related adverse events.	6 months
Secondary	efficacy	anti-tumor activity of CART-19 cells will be determined in a follow-on study	2 years
Secondary	duration of CART-19	Determine duration of in vivo survival of CART-19 cells.	2 years