Myeloma
Conditions
Interventions
Group 1:Intravenous infusion of TRuC-T cells targeting BCMA/FAP
Group 2:Intravenous infusion of TRuC-T cells targeting CD229/FAP
Group 3:Intravenous infusion of TRuC-T cells targeting BCMA/CD229/FAP
Sponsors
Jinshazhou Hospital, Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, regardless of gender. 2. The subject voluntarily participates in the study, and he or his legal guardian signs the "Informed Consent". 3. Meet the internationally accepted criteria for multiple myeloma (IMWG diagnostic criteria 2014 Appendix 1). 4. Subjects who are clearly diagnosed as relapsed or refractory myeloma and meet one of the following conditions: (1) The subject has received at least 2 lines of MM therapy (including proteasome inhibitors or immunomodulators, and the disease progressed or relapsed during or after the last treatment). Note: The planned treatment plan for one or more cycles is "first-line treatment", induction chemotherapy, stem cell transplantation and maintenance therapy (if there is no disease progression between them), it is regarded as one treatment plan; (2) The subject has received first-line treatment, but the investigator has judged that the patient has unsatisfied treatment needs or cannot benefit from the current treatment options. 5. The patient has one or more measurable multiple myeloma lesions, which must include any of the following: (1) Serum M protein day is 1.0g/dL (10g/L) or more; (2) Urine M protein is greater than or equal to 200mg/24h; (3) Serum free light chain (sFLC) detection: the ratio of k/FLC is abnormal and the involved FLC is 210 mg/dL. 6. After flow cytometry or immunohistochemical examination, the myeloma cells expressed positive BCMA/NKG2DL/FAP. 7. Within 2 weeks before cell therapy, have not received antibody drug treatment. 8. The ECOG score is 0-1 points. 9. Echocardiogram showed normal diastolic function, left ventricular ejection fraction (LVEF) >= 50%, and no serious arrhythmia. 10. The subject has no active infection in the division, normal lung function, and indoor air oxygen saturation >= 92%. 11. The subject has no contraindications for peripheral blood apheresis. 12. The estimated survival time > 12 weeks. 13. Female subjects of childbearing age must have a negative urine pregnancy test within 7 days before cell therapy and not during lactation; female or male subjects of childbearing age must take effective contraceptive measures throughout the study.
Exclusion criteria
Exclusion criteria: 1. There is a history of other tumors in the past 2 years 2. Have an autologous hematopoietic stem cell transplantation within six weeks 3. Previous allogeneic hematopoietic stem cell transplantation. 4. Active infection that cannot be controlled. 5. People infected with HIV. 6. Within one month or are receiving other biological treatments, chemotherapy or radiotherapy. 7. The researcher believes that the subject has other conditions that are not suitable for participating in this research
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Countries
China
Contacts
Public ContactLuo Rongcheng
Jinshazhou Hospital, Guangzhou University of Chinese Medicine
Outcome results
None listed