Background

CD7 is a transmembrane glycoprotein expressed on the surface membranes of T and NK cells and their precursor cells to stimulate cell activation. We have shown in pre-clinical studies that the cell-based immunotherapy targeting CD7 bio-drug (CD7-CAR-T) has excellent efficacies in the treatment of relapsed/refractory acute T lymphoblastic leukemia and lymphoma. The bio-drug has been approved by the National Medical Products Administration (China) (Reference number: CXSL2101087) for phase I clinical trial and met the ethical standards of clinical trials after reviewed by the ethics committee. The clinical trials are currently being carried out in 5 hospitals in China.

The major inclusion criteria

(1) Aged 18 to 70 years old (inclusive), male or female;

(2) Subjects diagnosed with malignant lymphoma according to WHO 2016 criteria:

T-cell acute lymphoblastic leukemia/lymphoma (including early pre-T-cell lymphoblastic leukemia) with priority,

Then

Subjects with relapsed/refractory acute T-lymphoblastic leukemia/lymphoma (including early-stage pre-T-lymphoblastic leukemia) who have failed standard therapies or lack of effective therapies, and meet any of the following criteria:

• Have not achieved remission after at least two courses of standard induction chemotherapies.

• Relapsed in the early stage (<12 months) after complete remission; or relapsed in the late stage (≥12 months) after complete remission and did not achieve remission with one more course of standard induction chemotherapy.

• Have not achieved remission after two or more courses of chemotherapies.

• Relapsed after hematopoietic stem cell transplantation.

(3) Subjects diagnosed with lymphoid hematologic malignancies and screened CD7-positive by flow cytometry and/or immunohistochemistry, with the positive rate of tumor cells ≥ 30%.

(4) CD-7-positive lymphoid hematologic malignancies with bone marrow and/or peripheral blood involvement, with immunophenotype of CD4 and CD8 double-negative on tumor cell membranes determined by flow cytometry.

Please contact us for more inclusion criteria.