childhood leukemia
Conditions
Interventions
CD19 and CD22 biscistronic CAR T treatment group:CD19 and CD22 biscistronic CAR T treatment
combined transfusions of CD19 and CD22 CAR T cells group: combined transfusions of CD19 and CD22 CAR T cells
Sponsors
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with refractory or elapsed B-ALL who received a combination of transfusions of CD19 and CD22 CAR T cells or CD19 and CD22 biscistronic CAR T cells regardless of concurrent extramedullary involvement, and regardless of prior CAR T therapy or hematopoietic stem cell transplantation 2.After CAR-T therapy, patients who are positive for the KMT2A or ZNF384 fusion gene may choose to bridge alloSCT according to their family economic situation 3. Patients who had previously failed CAR-T therapy had the option of bridging ALLOSCT after CAR-T therapy 4.The Karnofsky score needed to be greater than 50 if the patient was older than 16 years; a Lansky score needed to be greater than 50 if the patient was younger than 16 years 5.The patient and/or parents must sign the informed consent form
Exclusion criteria
Exclusion criteria: Subjects will not be included in the study if any of the following criteria applies: 1.Current autoimmune disease, or history of autoimmune disease with potential CNS involvement 2.Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis) 3.History of an additional malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease free for =3 years. 4.Pulmonary function: Patients with pre-existing severe lung disease (FEV1 or FVC 28% O2 supplementation or active pulmonary infiltrates on chest X-ray at the time scheduled for T cell infusion 5.Cardiac function: Fractional shortening 3 times upper limit of normal or an AST or ALT > 5 times upper limit of normal, unless due to leukemic liver infiltration in the estimation of the investigator 8.Rapidly progressive disease that in the estimation of the investigator would compromise ability to complete study therapy 9.Active Hepatitis B (HBsAg positive) or Hepatitis C (PCR positive), or known infection with human immunodeficiency virus (HIV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BM morphologic examination;WBC;BM MRD; Assessment on entry ;CAR-T cell infusion information ;Adverse reactions after CAR-T ;B cells recovered after CAR-T ; | — |
Secondary
| Measure | Time frame |
|---|---|
| csf MRD;Demographics:age,sex ;Information on diagnosis and treatment at first visit ;CAR-T cell duration ;CAR-T post-event and follow-up information ; | — |
Countries
China
Contacts
Public Contactjiaoyang cai
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed