A Study of CAR T-Cells in Relapsed/Refractory Hematologic Malignancy

Required: CD19 positive expression (ALL: bone marrow tumor cells ≥ 5%)

CD19+ ALL patients, with bone marrow smear reports showing tumor cells ≥ 5%

Required: CD19 positive expression

CD19+ NHL patients

Required: CD20 positive expression

CD20 expression positive at enrollment

Required: CD20 positive expression

Lymphoma with dual positive expression of CD20/CD30

Required: CD30 positive expression

Lymphoma with dual positive expression of CD20/CD30

Required: CD30 positive expression

CD30 positive HL

Required: CD30 positive expression

CD30 positive T-cell lymphoma

Must have received: systemic therapy — relapsed/refractory

Subjects with refractory or relapsed disease after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation) who are not suitable for other treatment options, such as a second stem cell transplant.

Cannot have received: clofarabine (clofarabine)

Use of clofarabine or cladribine within 3 months prior to enrollment

Cannot have received: cladribine (cladribine)

Use of clofarabine or cladribine within 3 months prior to enrollment

Cannot have received: PEG-asparaginase (PEG-asparaginase)

use of PEG-asparaginase within 3 weeks prior to enrollment

Cannot have received: donor lymphocyte infusion

Donor lymphocyte infusion (DLI) within 28 days prior to enrollment

Cannot have received: GVHD therapy (calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, thalidomide)

Any medications used for the treatment of GVHD (such as calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, thalidomide) within 4 weeks prior to enrollment

Cannot have received: immunosuppressive antibody (anti-CD20, anti-tumor necrosis factor, anti-interleukin-6, anti-interleukin-6 receptor)

immunosuppressive antibodies (such as anti-CD20, anti-tumor necrosis factor, anti-interleukin-6, or anti-interleukin-6 receptor) used within 4 weeks prior to enrollment

Cannot have received: immunosuppressive/stimulatory checkpoint molecule therapy (ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists)

Any systemic immunosuppressive/stimulatory checkpoint molecule therapy within 4 weeks prior to enrollment (such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc.)

Cannot have received: systemic cytotoxic chemotherapy (cyclophosphamide, ifosfamide, bendamustine, chlorambucil, methotrexate, vincristine)

Use of systemic cytotoxic drugs within 2 weeks prior to enrollment, including daily or weekly low-dose maintenance chemotherapy (such as cyclophosphamide, ifosfamide, bendamustine, chlorambucil, methotrexate, vincristine, etc.)

Cannot have received: growth factor (pegylated filgrastim)

Long-acting growth factors (e.g., pegylated filgrastim) within 14 days prior to leukapheresis

Cannot have received: growth factor (granulocyte colony-stimulating factor, filgrastim, plerixafor)

short-acting growth factors or mobilizing agents (e.g., granulocyte colony-stimulating factor/filgrastim, plerixafor) within 5 days prior to leukapheresis

Cannot have received: radiation therapy

Radiation therapy within 2 weeks prior to enrollment

Cannot have received: corticosteroid

Exception: ≤ 5 mg/day of prednisone or equivalent allowed

Use of pharmacological doses of corticosteroids (>5 mg/day of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive medications must be avoided within 7 days prior to enrollment

Cannot have received: BCL-2 inhibitor (venetoclax)

Use of venetoclax (BCL-2 inhibitor) within 4 days prior to leukapheresis

Cannot have received: tyrosine kinase inhibitor

Short-acting targeted therapy (e.g., tyrosine kinase inhibitors) within 72 hours prior to leukapheresis

Cannot have received: PI3K inhibitor (idelalisib)

Idelalisib (oral PI3Kδ inhibitor) within 2 days prior to leukapheresis

Cannot have received: immunomodulatory agent (lenalidomide)

Lenalidomide within 1 day prior to leukapheresis