A Clinical Study of CAR-T Cells in the Treatment of Relapsed and Refractory Hematological Malignancies

This is an expanded access trial for Relapsed and Refractory Hematological Malignancies focused on measuring Relapsed, Refractory, Hematological malignancy, CAR-T cells Read More

Inclusion Criteria:

• Patients suffering from a hematological malignancy that is severely life-threatening or seriously affects the patient's quality of life and has no effective treatment available, who not meet the inclusion/exclusion criteria for other clinical trials in the process of subject recruitment, or who are unable to obtain other study drugs or participate in clinical studies/trials for some reason (regional or time restriction, etc., or the recruitment of subjects for clinical studies/trials has ended but the drug has not yet been approved for marketing in China);

• Patients who are definitely diagnosed with the corresponding target-positive relapsed and refractory hematological malignancies, including but not limited to the following circumstances:

  • Patients who do not meet the inclusion/exclusion criteria for existing clinical trials, such as age <18 years, ECOG >1, extramedullary recurrence, persistent or repeatedly positive for minimal residual disease;
  • Patients who have relapsed after remission following CAR-T cell therapy, and are expected as judged by the investigator to benefit more from re-use of the same cell or sequential use of other CAR-T cells compared with the risk;
  • The quantity of CAR-T cells produced does not meet the release criteria of production quality inspection, but is >0.1× 106/kg CAR positive T cells, and the investigator judges that the expected benefit of cell infusion is greater than the risk;
  • The disease progresses rapidly after cell collection and before infusion, and the investigator judges that the expected benefit of cell infusion is greater than the risk;
  • Patients who have relapsed after autologous/heterogeneous hematopoietic stem cell transplantation (including those positive for minimal residual disease);
  • Other circumstances where the investigator judges that the expected benefit of cell infusion is greater than the risk.
• Patients with appropriate bone marrow reserve: such as lymphocyte count >0.3×109/L;
• Patients with proper heart, lung, liver, kidney and coagulation functions;
• The selected patients or their legal representatives voluntarily sign the informed consent form.

Exclusion Criteria:

• Patients who are positive for any of HIV antibody, TP antibody, HBsAg and HCV antibody.
• Patients with a history of epilepsy or other central nervous system diseases.
• Patients with evidence of currently uncontrollable serious active infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.).
• Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.