Leukemia, Lymphoma
Conditions
Brief summary
This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic and lymphoid malignancies. A total of 30 patients are planned to be enrolled over a period of 2 years.
Detailed description
Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30, CD7, BCMA, CD123, etc. may be potential in developing the corresponding CAR-T cells to treat patients whose tumors expressing those markers. Investigators have developed a high efficient platform for constructing different CARs and preclinical studies have demonstrated effective killing of corresponding target cells. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.
Interventions
BIOLOGICALAutologous CAR-T
Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing. The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration. Chemotherapy will then be given. Following tumor burden reassessment, CAR-T cells will be infused.
Sponsors
Hebei Medical University Fourth Hospital
Hebei Senlang Biotechnology Inc., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1.The treat history meeting the following criteria: 1. 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; 2. Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients; 3. 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
1. Serious cardiac insufficiency, left ventricular ejection fraction\<50; 2. Has a history of severe pulmonary function damaging; 3. Merging other malignant tumor; 4. Merging uncontrolled infection; 5. Merging the metabolic diseases (except diabetes); 6. Merging severe autoimmune diseases or immunodeficiency disease; 7. patients with active hepatitis B or hepatitis C; 8. patients with HIV infection; 9. Has a history of serious allergies on Biological products (including antibiotics); 10. Happened in 3 \ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients 11. Pregnancy or lactation women; 12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor load | Up to 24 months | Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CAR T cell persistence | Up to 24 months] | CAR T cell persistence will be quantified with flow cytometry and qPCR |
Countries
China
Contacts
Primary ContactJianqiang Li, PhD & MD
Outcome results
None listed