CS1+ hematological malignancy
Conditions
Sponsors
Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the clinical trials and sign the informed consent; 2. to be aged 18 to 70 years, male and female; 3. Patients with BCMA+ tumor diagnosed by pathology and histology, and have no effective treatment by now, including patients who are with relapsed disease after chemotherapy or hematopoietic stem cell transplantation (HSC); or patients are voluntary to accept anti-BCMA CAR-T cell therapy as the first-line therapy; 4. types of CS1+ tumor included: Multiple myeloma; Amyloidosis; POEMS syndrome; MGUS that needs treatment; 5. Patients enrolled in are meeting the following criteria: (1) Present residual disease after main therapy but not eligible for HSCT; (2) Relapse after CR1 but not eligible for HSCT; (3) Patients with high risk factors; (4) Failure to achieve remission or relapse after HSCT; 6. Patients with measurable lesions or with observable tumor foci; 7. Multiple organ function assessment: Creatinine =95%; Bilirubin 40%; 8. Without history of accepting anti-cancer therapy, including chemotherapy, radiotherapy, immunotherapy (immune suppressive drugs treatment) within 4 weeks of screening; 9. Adequate venous access for apheresis; 10. ECOG score =3 months.
Exclusion criteria
Exclusion criteria: 1. Pregnancy and nursing females; 2. Planning pregnancy within 1 year; 3. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening; 4. Systemic fungal, bacterial, viral, or other infection that is not controlled, at the time of screening; 5. active HBV/HCV infected; 6. any human immunodeficiency virus (HIV) infection; 7. History of accepting systemic steroids treatments within 4 weeks; 8. Allergic to any cytokines or antibodies; 9. Participation in an investigational research study within 6 weeks before enrolled; 10. History of accepting systemic steroids treatments within 4 weeks; 11. History of mental disorders; 12. Drug abuse and addiction; 13. Other situations we think improper for the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security;validity; | — |
Countries
China
Contacts
Public ContactJianfeng Zhou
Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed