Clinical trial NCT02963038: CAR T Cells for Refractory B Cell Malignancy
Official title: Autologous CD19-targeting CAR T Cells for Refractory B Cell Malignancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: B-Cell Leukemia
B-Cell Lymphoma
Lead sponsor: Hebei Senlang Biotechnology Inc., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The Second Hospital of Hebei Medical University
First posted: 2016-11-15
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell malignancy including lymphoma or leukemia.

Detailed description: The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Eligibility criteria: Inclusion Criteria:

1. The treat history meeting the following criteria:

   * Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation;
   * Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients;
   * One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.
2. There is a measurable lesions before treatment at least;
3. ECOG score≤2;
4. To be aged 1 to 70 years;
5. More than a month lifetime from the consent signing date

Exclusion Criteria:

* Serious cardiac insufficiency, left ventricular ejection fraction\<50;
* Has a history of severe pulmonary function damaging;
* Merging other malignant tumor;
* Merging uncontrolled infection;
* Merging the metabolic diseases (except diabetes);
* Merging severe autoimmune diseases or immunodeficiency disease;
* patients with active hepatitis B or hepatitis C;
* patients with HIV infection;
* Has a history of serious allergies on Biological products (including antibiotics);
* Happened in 3 \~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients Pregnancy or lactation women; Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Primary outcomes:
measure: Tumor load
timeFrame: Up to 24 months
Secondary outcomes:
measure: CAR T cell persistence
timeFrame: Up to 24 months
Other outcomes:
measure: B cell number and immunoglobulins in peripheral blood
timeFrame: Up to 12 months
Locations:
city: Shijiazhuang
country: China
facility: No.2 Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: The Second Hospital of Hebei Medical University
name: Jianmin Luo, PhD & MD
role: PRINCIPAL_INVESTIGATOR
References: