Relapsed or Refractory Multiple Myeloma
Conditions
Keywords
Relapsed and refractory multiple myeloma; CAR-T
Brief summary
This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+，CD19+ relapsed or refractory multiple myeloma.
Detailed description
CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory multiple myeloma by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to preliminary explore the safety, tolerability and cellular pharmacokinetics of Anti-BCMA and Anti-CD19 CAR-T cells in the treatment of relapsed or refractory multiple myeloma.
Interventions
BIOLOGICALAutologous BCMA CAR-T cells and CD19 CAR-T cells
Autologous BCMA CAR-T cells and CD19 CAR-T cells with average 1-5\*10\^6 cells/kg body weight,separately.
Sponsors
The First Affiliated Hospital of Nanchang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female aged 18-70 years old 2. Estimated Survival time \> 12 weeks 3. Relapsed and refractory multiple myeloma were confirmed by physical examination, pathological examination, laboratory examination and imaging 4. Chemotherapy failure or recurrent multiple myeloma 5. Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level 6. Bilirubin\<2.0mg/dl 7. Karnofsky Performance Status\>50% at the time of screening 8. Adequate pulmonary, renal, hepatic, and cardiac function 9. Fail in autologous haemopoietic stem cell transplantation 10. Not suitable for stem cell transplantation conditions or abandoned due to conditions 11. Free of leukocytes removal contraindications 12. Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent
Exclusion criteria
1. The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months 2. Patients have infectious diseases (such as HIV, active tuberculosis, etc.) 3. The patient is an active hepatitis B or hepatitis C infection 4. Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated 5. Abnormal vital signs 6. Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation. 7. Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2 8. General infection or local severe infection, or other infection that is not controlled 9. Dysfunction in lung, heart, kidney and brain 10. Severe autoimmune diseases 11. Other symptoms that are not applicable for CAR-T
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | 2 year | Assessment of ORR (ORR = sCR+CR+VGPR+PR ) at 1 months of treatment |
| minimal residual disease（MRD） | 2 year | Assessment of MRD negative overall response rate at 3 months of treatment |
| Progression-free survival (PFS) | 2 year | Assessment of Progression-free survival (PFS) at 6 months of treatment |
| Overall survival (OS) | 2 year | Assessment of overall survival (OS) at 6 months of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety (incidence of adverse events defined as dose-limited toxicity) | Study treatment until Week 24 | Occurrence of study related adverse events defined as NCI CTCAE 4.0 \> grade 3 possibly, probably, or definitely related to study treatment. |
| Expression of CD19 CART cells | 2 year | Expression of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR) and by flow cytometry. |
Countries
China
Contacts
Primary ContactFei LI, M.D.;Ph.D.
Outcome results
None listed