CAR T Cells for Refractory B Cell Malignancy

B-Cell Lymphoma Clinical Trial

Official title:

Autologous CD19-targeting CAR T Cells for Refractory B Cell Malignancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02963038
• Other study ID #: SenL_19
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 28, 2016
• Last updated: April 27, 2017
• Start date: June 2016
• Est. completion date: June 2021

Study information

• Verified date: November 2016
• Source: Hebei Senlang Biotechnology Inc., Ltd.
• Contact: jianqiang li, PhD & MD
• Phone: +8631189928689
• Email: limmune[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2021
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• B-Cell Leukemia
• B-Cell Lymphoma
• Leukemia, B-Cell
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma, B-Cell

Intervention

Biological:
• Autologous CD19-targeting CAR T cells
Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.

Locations

Country	Name	City	State
China	No.2 Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Hebei Senlang Biotechnology Inc., Ltd.	The Second Hospital of Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	B cell number and immunoglobulins in peripheral blood	The number of B cells and immunoglobulins in peripheral blood will be evaluated by routine methods	Up to 12 months
Primary	Tumor load	Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.	Up to 24 months
Secondary	CAR T cell persistence	Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis	Up to 24 months