Clinical trial NCT02186860: Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia
Official title: Treatment of Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia by Chimeric Antigen Receptor (CAR)-Modified T Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for fighting cancer. Many people do not respond to the standard treatments of ALL. One possible treatment is chimeric antigen receptor (CAR) modified T cell infusions. This study aims to evaluate the safety and efficacy of novel CARTs (targeting CD19) in the treatment of refractory or recurrent ALL.The investigators start Phase I study aimed to chemotherapy resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is to assess the safety and effectiveness of CAR-T cells in patients.

Detailed description: CAR-T has stronger effect of anti-tumor capacity. While people have been able to control the clinical complications now, so conducting CAR-T clinical trials has a strong demand and value. This study aims to evaluate the safety and efficacy of CD19-CART in treating refractory or recurrent ALL.

Eligibility criteria: Inclusion Criteria:

* Age: 18-65 years
* Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as confirmed by flow cytometry
* Refractory or relapsed B cell-acute lymphoblastic leukemia
* No available curative treatment options (such as hematopoietic stem cell transplantation)
* Stage III-IV disease
* Creatinine \< 2.5 mg/dl
* Aspartate transaminase-alanine transaminase ratio \< 3x normal
* Bilirubin \< 2.0 mg/dl
* Karnofsky performance status \>= 60
* Expected survival time \> 3 months
* Adequate venous access for apheresis
* Ability to understand and provide informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Patients requiring T cell immunosuppressive therapy
* Active central nervous system leukemia
* Any concurrent active malignancies
* Patients with a history of a seizure disorder or cardiac disorder
* Patients with human immunodeficiency virus, hepatitis B or C infection
* Uncontrolled active infection

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinical responses to third generation CAR-T cells
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Hematopoietic Stem Cell Transplantation
Study officials:
affiliation: Affiliated Hospital to Academy of Military Medical Sciences
name: Liangding Hu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang XY, Sun Y, Zhang A, Hu GL, Cao W, Wang DH, Zhang B, Chen H. Third-generation CD28/4-1BB chimeric antigen receptor T cells for chemotherapy relapsed or refractory acute lymphoblastic leukaemia: a non-randomised, open-label phase I trial protocol. BMJ Open. 2016 Dec 30;6(12):e013904. doi: 10.1136/bmjopen-2016-013904.