CAR T Cells for Refractory B Cell Malignancy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Tumor load [Up to 24 months]
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Secondary Outcome Measures
- CAR T cell persistence [Up to 24 months]
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis
Other Outcome Measures
- B cell number and immunoglobulins in peripheral blood [Up to 12 months]
The number of B cells and immunoglobulins in peripheral blood will be evaluated by routine methods
Eligibility Criteria
Criteria
Inclusion Criteria:
- The treat history meeting the following criteria:
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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;
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Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients;
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One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.
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There is a measurable lesions before treatment at least;
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ECOG scoreā¤2;
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To be aged 1 to 70 years;
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More than a month lifetime from the consent signing date
Exclusion Criteria:
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Serious cardiac insufficiency, left ventricular ejection fraction<50;
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Has a history of severe pulmonary function damaging;
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Merging other malignant tumor;
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Merging uncontrolled infection;
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Merging the metabolic diseases (except diabetes);
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Merging severe autoimmune diseases or immunodeficiency disease;
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patients with active hepatitis B or hepatitis C;
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patients with HIV infection;
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Has a history of serious allergies on Biological products (including antibiotics);
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | No.2 Hospital of Hebei Medical University | Shijiazhuang | Hebei | China | 050000 |
Sponsors and Collaborators
- Hebei Senlang Biotechnology Inc., Ltd.
- The Second Hospital of Hebei Medical University
Investigators
- Principal Investigator: Jianmin Luo, PhD & MD, The Second Hospital of Hebei Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SenL_19