blood system malignant tumor
Conditions
Interventions
Sponsors
The Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old; 2. Morphological analysis showed that the load of bone marrow lymphoma was greater than 5%; 3. Expected survival time: > 12 weeks; 4. The Attending physician believe that there is no other feasible and effective alternative treatment, such as hematopoietic stem cell transplantation; 5. Recurrent/refractory B-cell acute lymphocytic leukemia (ALL): (1) Grade 2 or higher bone marrow relapse objective remission rate (OR) (2) Any BM relapse after allogeneic SCT and must be > 6 months from SCT at the time of CTL019 infusion OR (3) Refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen chemotherapy regimen or chemorefractory as defined by not achieving a CR after 1 cycle of standard chemotherapy for relapse leukemia OR (4) Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI), or if TKI therapy is contraindicated OR (5) Ineligible for allogeneic SCT. 6. For relapsed patients, CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry within 3 months of study entry; 7. Expression of CD19 on lymphoma cells: immunohistochemical detection >15% or flow cytometry detection >30%; 8. Adequate organ function defined as: (1) Renal function defined as (Calculated creatinine clearance or radioisotope Glomerular Filtration Rate (GFR) > 60 mL/min/1.73 m2 OR serum creatinine based on age/gender (2) Alanine Aminotransferase (ALT) 91% on room air; (5) Left Ventricular Shortening Fraction (LVSF) = 28% confirmed by echocardiogram, or Left Ventricular Ejection Fraction (LVEF) = 45% confirmed by echocardiogram or MUGA within 7 days of screening; 9. Karnofsky (age = 16 years) or Lansky (age < 16 years) performance status = 50 at screening; 10. Signed written informed consent and assent forms (if applicable) must be obtained prior to any study procedures; 11. Once all other eligibility criteria are confirmed, must have an apheresis product of non-mobilized cells received and accepted by the manufacturing site. Note: Apheresis product will not be shipped to or assessed for acceptance by the manufacturing site until documented confirmation of all other eligibility criteria is received.
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. Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell [surface Immunoglobulin (sIg) positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation) 4. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease 5. Prior treatment with gene therapy product 6. Treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy 7. Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening 8. HIV positive test within 8 weeks of screening 9. Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD) 10. The following medications are excluded: (1) Steroids: Therapeutic systemic doses of steroids must be stopped > 72 hours prior to CART-19 infusion. However, the following physiological replacement doses of steroids are allowed: 6 weeks prior to CART-19 infusion (3) GVHD therapies: Any systemic drug used for GVHD must be stopped > 4 weeks prior to CART-19 infusion to confirm that GVHD recurrence is not observed (e.g. calcineurin inhibitors, methotrexate or other chemotherapy drugs, mycophenolyate, rapamycin, thalidomide, or immunosuppressive antibodies such as anti-CD20 (rituximab), anti-tumor necrosis factor [anti-TNF], anti-interleukin 6 [anti-IL6] or anti-interleukin 6 receptor [anti-IL6R], systemic steroids). (4) Chemotherapy: Tyrosine kinase inhibitors and hydroxyurea must be stopped > 72 hours prior to CART-19 infusion The following drugs must be stopped > 1 week prior to CART-19 infusion and should not be administered concomitantly or following lymphodepleting chemotherapy: vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate 2 weeks prior to CART-19 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside > 100 mg/m2, anthracyclines, cyclophosphamide, methotrexate = 25 mg/m2), excluding the required lymphodepleting chemotherapy drugs; (5) CNS prophylaxis treatment must be stopped > 4 week prior to CART-19 infusion (e.g. intrathecal methotrexate) f. Radiotherapy; 11. women who were pregnant or lactation: the female test participants had to test the serum or urine pregnancy 48 hours before the transfusion, and the results were positive; 12. women of childbearing age and all male patients did not take effective contraception within 1 years after CART-19 return.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete relieved; | — |
Countries
China
Contacts
Public ContactLin Yang
PersonGen·Anke Cellular therapeutics Co., Ltd.
Outcome results
None listed