Efficacy of CART-19 Cell Therapy in B Cell Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02810223
• Other study ID #: IT1601-CART19
• Status: Recruiting
• Phase: Phase 1
• First received: June 16, 2016
• Last updated: October 13, 2016
• Start date: May 2016

Study information

• Verified date: June 2016
• Source: Beijing Sanwater Biological Technology Co., Ltd.
• Contact: Peng Shicheng
• Phone: 86-10-82491911-6000
• Email: jay.zhang[@]sanvalley.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a single arm, open-label, multi-center study to determine the efficacy and safety of an experimental therapy called CART-19 in patients with chemo-refractory and relapsed B-cell ALL.

Description:

This is a single arm, open-label, multi-center, phase I study to determine the efficacy of CTL019 in patients with r/r B-cell ALL. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation & Lymphodepleting Chemotherapy), Treatment and Primary Follow-up, Secondary Follow-up (if applicable) and Survival Follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 60 Years

Eligibility

Inclusion Criteria:

• Male and female subjects with CD 19+ B cell acute lymphoblastic leukemia in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to <2 year survival) with currently available therapies will be enrolled

1. Age 1 to 60 years.

2. Expected survival > 12 weeks

3. Creatinine < 2.5 mg/dl and less than 2.5x normal for age

4. ALT = 5x normal

5. Bilirubin <2.0 mg/dl

6. Any relapse after prior SCT will make patient eligible regardless of other prior therapy

7. Patients with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) will be eligible if they meet all other inclusion criteria and

?. Have no active GVHD and require no immunosuppression

?. Are more than 4 months from transplant

8. For those patients who require leukapheresis for T cell collection (i.e. no previously collected product exists), adequate venous access for apheresis or eligible for appropriate catheter placement, and no other contraindications for leukapheresis

9. Voluntary informed consent is given

10. Patients with CNS3 disease will be eligible if CNS disease is responsive to therapy (at infusion)

Exclusion Criteria:

1. Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion

2. Uncontrolled active infection

3. Active hepatitis B or hepatitis C infection

4. Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of inhaled steroids, or hydrocortisone for physiological replacement in patients with adrenal insufficiency are permitted as well

5. Presence of grade 2-4 acute or extensive chronic GVHD

6. Under treatment for GVHD

7. Previous treatment with any gene therapy products

8. Any uncontrolled active medical disorder that would preclude participation as outlined.

9. HIV infection.

10. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Biological:
• CART-19
2 to 5 x 10(6) autologous CART-19 transduced cells per kg body weight, with a maximum dose of 2.5 x 10(8) autologous CTL019 transduced cells via intravenous infusion.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Sanwater Biological Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		2 years	Yes