B cell malignancies
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Relapsed or refractory B cell malignancies: (1) Relapsed or refractory B ALL; Relapse was defined as presence of > 5% blasts at screening, or second or subsequent bone marrow (BM) relapse, or any BM relapse after allogeneic SCT and must be = 6 months from SCT at the time of CD19 CAR-T infusion. Refractory was defined by not achieving an initial CR after 2 cycles of a standard chemotherapy regimen (primary refractory). Patients who were refractory to subsequent chemotherapy regimens after an initial remission were considered chemorefractory; (2) Patients with Ph+ ALL were eligible if they are intolerant to or have not achieved a remission after two lines of TKI (tyrosine kinase inhibitor) therapy, or if TKI therapy is contraindicated, or ineligible for allogeneic SCT because of: a.Comorbid disease; b. Other contraindications to allogeneic SCT conditioning regimen; c.Lack of suitable donor; d.Prior hematopoietic stem cell transplant (HSCT); e.Declined allogeneic HSCT as a therapeutic option (3) Relapsed or refractory NHL: 1) Histopathological CD19+. 2) No response to last line of therapy i. PD as best response to most recent therapy regimen ii. SD as best response to most recent therapy with duration no longer than 6 month from last dose of therapy OR Refractory post-ASCT i. Disease progression or relapsed less than or equal to 12 months of ASCT (must have biopsy proven recurrence in relapsed subjects) ii. If salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy; 3) Subjects must have received adequate prior therapy including at a minimum: anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative and an anthracycline containing chemotherapy regimen for subjects with transformed FL must have received prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to DLBCL; 4) At least one measurable lesion per revised IWG Response Criteria; 2. Aged 18-75 years old; 3. Expected survival = 12 weeks; 4. Adequate renal, hepatic, pulmonary and cardiac function defined as: 1) Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min; 2) Serum ALT/AST 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant pleural effusion; 5) Baseline oxygen saturation >92% on room air; 5. Eastern cooperative oncology group (ECOG) performance status of 0 - 2; 6. Pregnant or lactating women must have a negative pregnancy test before infusion, and agree to take effective contraception during the trial; 7. Apheresis product received and accepted; 8. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Isolated extra-medullary relapse leukemia; 2. Other malignancies; 3. Concomitant genetic syndrome, with the exception of Down Syndrome; 4. Burkitt's lymphoma/leukemia; 5. Treatment with any prior gene therapy product, anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy; 6. Active hepatitis B, C, or any uncontrolled infection; 7. Grade 2 to 4 Graft versus Host Disease (GVHD); 8. Medications or treatments that were to be excluded: 1) Corticosteroids within 72 hours of infusion, with the exception of physiologic replacement; 2) Allogeneic cellular therapy, such as donor lymphocyte infusion within 6 weeks prior to infusion; 3) GVHD therapies; 4) Chemotherapy stopped prior to lymphodepletion based on clearance; 5) CNS prophylaxis treatment; 9. Active central nervous system (CNS) disease (CNS 2 disease [CSF containing blasts, but < 5 WBCs/microliter] patients were eligible); 10. Any condition that investigator considered may increase the risk of the subjects or interfere with the trial results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade of Toxicities and Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Countries
China
Contacts
Public ContactXia Ruixiang
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed