To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.
Sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet;
Diagnosed as recurrent or refractory lymphoma, leukemia or myeloma;
Tumor cells express targets for CAR-T cell therapy (results: flow cytometry or Immunohistochemical test confirmation);
Age 14-75 (including threshold), gender unlimited;
Severe cardiac insufficiency;
Have a history of severe lung impairment;
Complicated with other advanced malignant tumors;
Complicated with severe or persistent infection that cannot be effectively controlled;
Single group
CAR-T Autologous T cell injection
Biological/VaccineBiological: CAR-T; Drug: Cyclophosphamide,Fludarabine；Procedure: Leukapheresis
Safety: Incidence and severity of adverse events
To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Efficacy: Remission Rate
Complete remission (CR) Complete remission with incomplete recovery of blood cells (CRI), positive minimal residual tumor (MRD+) or negative tumor (MRD -) CR/CRI, disease recurrence or progression (PD) were evaluated, and the overall remission rate was ORR=CR+CRI; For drenching Complete remission (CR), partial remission (PR), disease stability (SD) Disease recurrence or progression (PD) was evaluated, and the overall remission rate was ORR=CR+PR; For multiple myeloma Complete remission (CR), partial remission (VGPR, PR), disease stability (SD), disease recurrence or progression (PD) were adopted, Overall remission rate ORR=CR+VGPR+PR;
progression-free survival (PFS)
progression-free survival (PFS) time
CAR-T proliferation
the copy number of Senl CAR- T cells in the genomes of PBMC by qPCR method
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
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Hebei Senlang Biotechnology Inc., Ltd.
Lead sponsor
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborator
