CAR T Cells for Refractory B Cell Malignancy

Hebei Senlang Biotechnology

Status and phase: Unknown; Phase 2; Phase 1

Conditions: B-Cell Leukemia; B-Cell Lymphoma

Treatments: Biological: Autologous CD19-targeting CAR T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02963038

SenL_19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 1 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

CD19 CAR T cells

Experimental group

Description:

Autologous CD19-targeting CAR T cells

Treatment:

Biological: Autologous CD19-targeting CAR T cells