A Phase 1/2 interventional study of Autologous CAR-T cells in Leukemia, Lymphoma and Multiple Myeloma of Bone (Diagnosis), sponsored by Hebei Senlang Biotechnology Inc., Ltd.. Status unknown at 1 site in China. Open to participants aged 1 Year to 70 Years. Per ClinicalTrials.gov, last updated 2019-01-09.
Sponsored by Hebei Senlang Biotechnology Inc., Ltd. · Phase 1/2, Interventional, and Treatment
This is an open, single-arm, phase I/phase II 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 50 patients are planned to be enrolled over a period of 2 years.
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,BCMA, CLL-1, 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.
Exclusion Criteria:
Patients will be be treated with autologous CAR-T cells
Biological: Autologous CAR-T cells
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.
Tumor load
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Time frame: Up to 24 months
CAR-T cell persistence
CAR-T cell persistence will be quantified with flow cytometry and qPCR
Time frame: Up to 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hebei Senlang Biotechnology Inc., Ltd.