Phase I Clinical Trial of RC19D2 Cell Injection in the Treatment of Diffuse Large B-cell Lymphoma

Required: CD19 positive

Patients with diffuse large B-cell lymphoma who have been diagnosed as CD19 positive by histopathology and/or cytology

Allowed: MYC rearrangement

High grade B-cell lymphoma (HGBL) with MYC, BCL2, and/or BCL6 rearrangement

Allowed: BCL2 rearrangement

High grade B-cell lymphoma (HGBL) with MYC, BCL2, and/or BCL6 rearrangement

Allowed: BCL6 rearrangement

High grade B-cell lymphoma (HGBL) with MYC, BCL2, and/or BCL6 rearrangement

Must have received: anthracycline

CD20 positive individuals must have already used sufficient amounts of CD20 targeted drugs and anthracycline drugs

Must have received: CD20-targeted therapy

CD20 positive individuals must have already used sufficient amounts of CD20 targeted drugs and anthracycline drugs

Must have received: autologous hematopoietic stem cell transplantation

Recurrence, unrelieved, or progression after autologous hematopoietic stem cell transplantation

Cannot have received: allogeneic hematopoietic stem cell transplantation

Individuals with a history of allogeneic hematopoietic stem cell transplantation

Cannot have received: organ transplantation

Individuals with a history of organ transplantation

Cannot have received: genetically modified T cell therapy

Those who have previously received other genetically modified T cell therapies, or other CAR-T therapies, or any other targeted therapy against CD19

Cannot have received: CAR-T cell therapy

Those who have previously received other genetically modified T cell therapies, or other CAR-T therapies, or any other targeted therapy against CD19

Cannot have received: CD19-targeted therapy

Those who have previously received other genetically modified T cell therapies, or other CAR-T therapies, or any other targeted therapy against CD19

Cannot have received: Bendamustine (Bendamustine)

Within 9 months prior to PBMC collection, received treatment with Bendamustine

Cannot have received: Alemtuzumab (Alemtuzumab)

Within 9 months prior to PBMC collection, received treatment with Alenzumab

Cannot have received: Fludarabine (Fludarabine)

Within 9 months prior to PBMC collection, received treatment with Fludarabine

Cannot have received: Cladribine (Cladribine)

Within 9 months prior to PBMC collection, received treatment with Cladribine

Cannot have received: chemotherapy (methotrexate, cyclophosphamide, ifosfamide, benzoate nitrogen mustard, mefalam)

Within 4 weeks prior to PBMC collection, patients received...chemotherapy drugs (methotrexate, cyclophosphamide, ifosfamide, benzoate nitrogen mustard or mefalam,)

Cannot have received: calcineurin inhibitor

Within 4 weeks prior to PBMC collection, patients received...calcineurin inhibitors

Cannot have received: mycophenolate (mycophenolate)

Within 4 weeks prior to PBMC collection, patients received...mycophenolate

Cannot have received: thalidomide (thalidomide)

Within 4 weeks prior to PBMC collection, patients received...thalidomide

Cannot have received: immunosuppressive antibody (anti TNF, anti IL6, anti IL6R)

Within 4 weeks prior to PBMC collection, patients received...immunosuppressive antibodies such as anti TNF, anti IL6, or anti IL6R therapy

Cannot have received: tumor radiotherapy

Within 4 weeks prior to PBMC collection, patients received...tumor radiotherapy

Cannot have received: FKBP12-binding drug (rapamycin, tacrolimus, everolimus)

Within 4 weeks prior to PBMC collection, patients received...drugs that can bind to FKBP 12 protein (such as rapamycin, tacrolimus, everolimus, etc.)

Cannot have received: long acting cell growth factor (PEG-rhG-CSF)

Long acting cell growth factors (such as polyethylene glycol recombinant human granulocyte stimulating factor PEG-rhG-CSF) were used within 3 weeks prior to PBMC collection

Cannot have received: GM-CSF (GM-CSF)

Received granulocyte macrophage colony stimulating factor (GM-CSF) treatment within 2 weeks prior to PBMC collection

Cannot have received: short-term cell growth factor (recombinant human granulocyte colony-stimulating factor, recombinant human thrombopoietin)

Individuals who have received short-term cell growth factors (such as recombinant human granulocyte colony-stimulating factor, recombinant human thrombopoietin, etc.)

Cannot have received: hematopoiesis agonist/stimulator (haitrapopa ethanolamine tablets)

hematopoiesis agonists/stimulators (such as haitrapopa ethanolamine tablets)

Cannot have received: CD20 monoclonal antibody

CD20 monoclonal antibodies

Cannot have received: corticosteroid

Exception: excluding those who have received inhaled, local steroid therapy, and physiological replacement therapy for adrenal insufficiency

corticosteroids within 7 days prior to PBMC collection (excluding those who have received inhaled, local steroid therapy, and physiological replacement therapy for adrenal insufficiency)

Cannot have received: platelet transfusion

Received platelet transfusion within 7 days before the screening period