Multiple myeloma
Conditions
Interventions
Case series:Infusion of cells
Sponsors
The Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 14-70 years old at the first diagnosis; 2. CD138+ relapsed or refractory multiple myeloma; 3. Expected life cycle> 12 weeks; 4. The attending physician believe that there is no other feasible and effective alternative treatment for patients, such as hematopoietic stem cell transplantation; 5. Relapsed/refractory multiple myeloma (MM): (1) Grade 2 or higher bone marrow relapse objective remission rate (OR); (2) Recurrence after allogeneic stem cell transplantation (SCT), SCT for more than 6 months prior to CART-138 transfusion and in OR state; (3) Refractory patients (after 2 rounds of standard chemotherapy); (4) receiving allogeneic stem cell transplantation (SCT); 6. For relapsed patients, tumor cells in the bone marrow were flow-detected for expression of CD138 within 3 months prior to enrollment; 7. The main organs are functional, including: (1) Renal function: radioisotope glomerular filtration rate> 60 mL/min/1.73 m2, or serum creatinine clearance in accordance with relevant age/gender criteria; (2) Alanine transferase (ALT) 91%; (5) Echocardiography or multi-port angiography (MUGA) showing fractional shortening of the ventricular minor semi axis (FS) = 28%, or left ventricular ejection fraction (LVEF) = 45%; 8. Karnofsky score (age = 16 years old) = 50 or Zubrod-ECOG-WHO score = 2; 9. Sign written informed consent and must obtain consent before any research is conducted; 10. When the above other conditions are met, the cell culture factory must receive fresh blood samples from the patient.
Exclusion criteria
Exclusion criteria: 1. Isolated extra-medullary disease relapse; 2. Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded; 3. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease; 4. Treatment with any prior gene therapy product; 5. Has had treatment with any prior anti-CD138/anti-CD3 therapy, or any other anti-CD138 therapy; 6. Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening; 7. Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening; 8. Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD); 9. The following medications are excluded: (1) Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CART-138 infusion. However, the following physiological replacement doses of steroids are allowed: 6 weeks prior to CART-138 infusion; (3) GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to CART-138 infusion (e.g. calcineurin inhibitors, methotrexate or other chemotherapy drugs, mycophenolyate, rapamycin, thalidomide, or immunosuppressive antibodies such as anti-CD20 (rituximab), anti-TNF, anti-IL6 or anti-IL6R); (4) Chemotherapy: The following drugs must be stopped > 1 week prior to CART-138 infusion and should not be administered concomitantly or following lymphodepleting chemotherapy: hydroxyurea, vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate 2 weeks prior to CART-138 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside > 100 mg/m2, anthracyclines, cyclophosphamide), excluding the required lymphodepleting chemotherapy drugs Pegylated-asparaginase must be stopped > 4 weeks prior to CART-138 infusion; (5) CNS disease prophylaxis: CNS prophylaxis treatment must be stopped > 1 week prior to CART-138 infusion (e.g. intrathecal methotrexate) 10. Active CNS involvement by malignancy, defined by CNS-3 per NCCN guidelines; 11. Pregnant or nursing women; 12. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CART-138 infusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete relief; | — |
Countries
China
Contacts
Public ContactLin Yang
PersonGen·Anke Cellular therapeutics Co., Ltd.
Outcome results
None listed