Relapsed and refractory hematological malignancies
Conditions
Interventions
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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); 2. Patients who are definitely diagnosed with the corresponding target-positive relapsed and refractory hematological malignancies, including but not limited to the following circumstances: 1) Patients who do not meet the inclusion/exclusion criteria for existing clinical trials, such as age 1, extramedullary recurrence, persistent or repeatedly positive for minimal residual disease; 2) 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; 3) The quantity of CAR-T cells produced does not meet the release criteria of production quality inspection, but is >0.1x10^6/kg CAR positive T cells, and the investigator judges that the expected benefit of cell infusion is greater than the risk; 4) 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; 5) Patients who have relapsed after autologous/heterogeneous hematopoietic stem cell transplantation (including those positive for minimal residual disease); 6) Other circumstances where the investigator judges that the expected benefit of cell infusion is greater than the risk. 3. Patients with appropriate bone marrow reserve: such as lymphocyte count >0.3x10^9/L; 4. Patients with proper heart, lung, liver, kidney and coagulation functions; 5. The selected patients or their legal representatives voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who are positive for any of HIV antibody, TP antibody, HBsAg and HCV antibody; 2. Patients with a history of epilepsy or other central nervous system diseases; 3. Patients with evidence of currently uncontrollable serious active infections (e.g., sepsis, bacteremia, fungalemia, viremia, etc.); 4. Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;RFS;DOR;OS;Adverse events;Physical examination;Vital signs;Laboratory tests; | — |
Countries
China
Contacts
Public ContactJianxiang Wang
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed