Status:
UNKNOWN
Safety and Efficacy Evaluation of IM19 Cells
Lead Sponsor:
Beijing Immunochina Medical Science & Technology Co., Ltd.
Conditions:
Hematological Malignancies
Eligibility:
All Genders
4-75 years
Phase:
PHASE1
Brief Summary
Assessment of the Safety and Feasibility of Administering T cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell Hematological Malignancies.
Detailed Description
Assessment of the Safety and Feasibility of Administering T cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell Hematological Malignancies(including B-cell Acute lymp...
Eligibility Criteria
Inclusion
- Patients with CD19 positive relapsed or refractory B-cell malignancies, including B-cell Acute Lymphocytic Leukemia(ALL)、B-cell Chronic Lymphocytic Leukemia(CLL)、Non-Hodgkin's lymphoma(NHL).
- 1)Patients with ALL:
- Previously treated with at least two courses of chemotherapy Ⅱ The interval of the last chemotherapy and disease progression is less than one year.
- Ⅲ Not suitable for allogeneic stem cell transplantation. 2)Patients with CLL:
- Previously treated with at least two courses of chemotherapy
- Ⅱ The interval of the last chemotherapy and disease progression is less than two years.
- Ⅲ Not suitable for allogeneic stem cell transplantation conditions or due to conditions to abandon allogeneic stem cell transplantation.
- 3\) Patients with DLBCL or FL、PMBCL:
- Patients who relapsed or were refractory after at least two previous treatments.
- Ⅱ Patients who relapsed after transplantation. 4)Patients who have relapsed or have refractory mantle cell lymphoma after at least one treatment.
- Measurable disease,including minimal residual disease. 3.Gender is not limited, to be aged 4 to 75 years 4.Expected survival \>3 months. 5.Eastern Cooperative Oncology Group(ECOG) score 0-2. 6.Women of childbearing potential must have a blood pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
- Absence of symptoms of central nervous system(CNS) leukemia.
Exclusion
- Patients who have been treated with chemotherapy or radiotherapy within 2 weeks before blood collection.
- Patients have GVHD, which needs treatment with immunosuppressive agents,or patients with autoimmune diseases.
- Patient who have been treated with systemic steroid medication within two weeks of blood collection（Except for the recent or current use of inhaled steroids）.
- Patient who have been treated with stimulation of bone marrow hematopoietic cells generated drugs(Such as Recombinant Human Granulocyte Colony-stimulating Factor Injection) within 2 weeks before the blood collection period to use .
- The number of T cells in peripheral blood is lower than 2×10\^8/L.
- Previously treatment with any gene therapy products.
- History of epilepsy or other CNS disease.
- New York Heart Association(NYHA) grade≥Ⅲ.
- Creatinine\> 1.5×normal value，Alanine transaminase(ALT) /Aspartate aminotransferase(AST)\>3×normal value，Bilirubin \>2×normal value.
- Degree of myeloproliferation： Ⅳ-V
- Active hepatitis B , hepatitis C or HIV infection and cytomegalovirus infection ,Epstein-Barr virus infection or any other uncontrolled active infection.
- Pregnancy or breast-feeding women.
- Any uncontrolled medical disorders that the researchers considered are not suitable to participate the clinical trial.
- Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Key Trial Info
Start Date :
August 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03344705
Start Date
August 21 2017
End Date
December 1 2020
Last Update
November 17 2017
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China