CAR T Cells for Refractory B Cell Malignancy

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

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.

Study Overview

• Status: Unknown
• Conditions: B-Cell Leukemia; B-Cell Lymphoma
• Intervention / Treatment: Biological: Autologous CD19-targeting CAR T cells

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • No.2 Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CD19 CAR T cells; Autologous CD19-targeting CAR T cells	Biological: Autologous CD19-targeting CAR T cells; Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor load	Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAR T cell persistence	Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis	Up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hebei Senlang Biotechnology Inc., Ltd.
• Collaborators: The Second Hospital of Hebei Medical University
• Investigators: Principal Investigator: Jianmin Luo, PhD & MD, The Second Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: October 28, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (ESTIMATE): November 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, B-Cell
• Other Study ID Numbers: SenL_19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO