Clinical trial NCT03327285: C-CAR011 Treatment in Subjects With ALL After HSCT
Official title: A Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Subjects With Acute Lymphoblastic Leukemia(ALL) After Hematopoietic Stem Cell Transplantation（HSCT）
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Lymphoblastic Leukemia(ALL)
Keywords: Acute lymphoblastic leukemia
Hematopoietic stem cell transplantation
Anti-CD19 chimeric antigen receptor T-cell
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai AbelZeta Ltd.
First posted: 2017-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief summary: This is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT

Detailed description: A study evaluating safety and efficacy of CBM.CD19-targeted chimeric antigen receptor T cells (C-CAR011) treatment in subjects with acute lymphoblastic leukemia(ALL) after hematopoietic stem cell transplantation（HSCT）. The amount of cells received：1.0-5.0×10\^6CAR+T cells/kg

Eligibility criteria: Inclusion Criteria:

* Age 15-65 years old, male or female.
* Volunteered to participate in this study and signed informed consent.
* Meet the two populations above.
* Histologically diagnosed as CD19+B-ALL.
* 100% T lymphocytes of donor.
* Treatment without chemotherapy and antibody therapy within 2 weeks prior to C-CAR011 therapy.
* Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias.
* Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection.
* Expected survival ≧ 3 months.
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* History of allergy to cellular products.
* Any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin\<35g/L, ALT, AST≧3×ULN, serum creatinine≧2.0mg/ dl,platelets\<20×109/L.
* The subjects had active aGVHD with II-IV degrees (Glucksberg degrees) or active moderate to severe cGVHD.
* Severe uncontrolled infection (mycotic, bacterial, virus and so on).
* Any central nervous system leukemia(CNS2, CNS3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible.
* The subjects were treated CART cells or DLI after HSCT.
* Bone marrow failure syndrome（BMF） after allogeneic hematopoietic stem cell transplantation.
* Any genetically modified T cell therapy.
* History of heavy drinking, drug taking or mental disease.
* Participated in any other clinical trial within one month prior to enrollment.
* Women who are pregnant or lactating or have breeding intent in 6 months.
* The investigators believe that any increase in the risk of the subject or interference with the results of the trial.

Primary outcomes:
measure: TEAEs
timeFrame: 2 months
measure: GVHD
timeFrame: 2 months
Secondary outcomes:
measure: Recurrence rate
timeFrame: 6 and 12 months
measure: OS
timeFrame: 12 months
measure: PFS
timeFrame: 12 months
measure: Remission rate
timeFrame: 2 weeks to 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Hematology
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Xiaojun Huang
role: PRINCIPAL_INVESTIGATOR
References: