Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2017-08-21
2020-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IM19 CART
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.
IM19 CAR-T
All patients will be treated with fludarabine and cyclophosphamide for 3 days. Two days later, Cells Expressing an Anti-CD19 Chimeric Antigen Receptor will be infused.
Fludarabine
Two days before cell infusion,all patients will be treated with fludarabine for 3 days
Cyclophosphamide
Two days before cell infusion,all patients will be treated with cyclophosphamide for 3 days
Interventions
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IM19 CAR-T
All patients will be treated with fludarabine and cyclophosphamide for 3 days. Two days later, Cells Expressing an Anti-CD19 Chimeric Antigen Receptor will be infused.
Fludarabine
Two days before cell infusion,all patients will be treated with fludarabine for 3 days
Cyclophosphamide
Two days before cell infusion,all patients will be treated with cyclophosphamide for 3 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
2.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.
7.Absence of symptoms of central nervous system(CNS) leukemia.
Exclusion Criteria
2. Patients have GVHD, which needs treatment with immunosuppressive agents,or patients with autoimmune diseases.
3. 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）.
4. 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 .
5. The number of T cells in peripheral blood is lower than 2×10\^8/L.
6. Previously treatment with any gene therapy products.
7. History of epilepsy or other CNS disease.
8. New York Heart Association(NYHA) grade≥Ⅲ.
9. Creatinine\> 1.5×normal value，Alanine transaminase(ALT) /Aspartate aminotransferase(AST)\>3×normal value，Bilirubin \>2×normal value.
10. Degree of myeloproliferation： Ⅳ-V
11. Active hepatitis B , hepatitis C or HIV infection and cytomegalovirus infection ,Epstein-Barr virus infection or any other uncontrolled active infection.
12. Pregnancy or breast-feeding women.
13. Any uncontrolled medical disorders that the researchers considered are not suitable to participate the clinical trial.
14. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
4 Years
75 Years
ALL
No
Sponsors
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Beijing Immunochina Medical Science & Technology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hongmei Jing, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xinan Lu, Dr
Role: primary
References
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Bao F, Wan W, He T, Qi F, Liu G, Hu K, Lu XA, Yang P, Dong F, Wang J, Jing H. Autologous CD19-directed chimeric antigen receptor-T cell is an effective and safe treatment to refractory or relapsed diffuse large B-cell lymphoma. Cancer Gene Ther. 2019 Jul;26(7-8):248-255. doi: 10.1038/s41417-018-0073-7. Epub 2019 Jan 9.
Other Identifiers
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YMCART201701
Identifier Type: -
Identifier Source: org_study_id