Phase
Condition
N/ATreatment
ThisCART19A
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
All subjects or legal representatives must sign a voluntary letter of consentapproved by the IRB in person prior to the commencement of any screening procedure;
Patients diagnosed with B-ALL according to the Chinese Guidelines for the Diagnosisand Treatment of Adult Acute Lymphoblastic Leukemia (2021 edition);
There is no gender limitation, age 18-65 (upper limit not included);
Consistent with the diagnosis of recurrent refractory B-ALL. Recurrence: was definedas the recurrence of lymphoblasts(≥5%) in peripheral blood or bone marrow orextramedullary diseasefor patients who had acquired CR ; Refractory :was defined asfailure to CR or CRi at the end of induction therapy (generally referred to 4-weekregimen or Hyper-CVAD regimen);Patients with Ph+ R/R ALL who failed after 2-line TKItreatment, were intolerant to TKI treatment or were not suitable for TKI treatment; The following factors can coexist: A) Failure to prepare autologous CAR-T (definition: too few autologous lymphocytes [200/ML] or cannot meet the release standard); B) Experienced treatment with autocar-T/berintoomumab/ CD22 antibody conjugation drugs; C) ≥100 days afterhematopoietic stem cell transplantation; D) high-risk patients (High risk wasdefined as a high white blood cell count ≥30×109/L at diagnosis or with poorcytogenetic prognosis);
Hypodiploid (<44 chromosomes);
KMT2A rearrangement: t (4;11) or otherwise;
t (v;q32)/IgH;
t (9;22) (q34;q11.2) or BCR-ABL1;
Complex karyotype (≥5 chromosomal abnormalities);
BCR-ABL1-like (Ph-like) ALL;
JAK-STAT (CRLF2r, EPORr, JAK1/2/3r, TYK2r, mutations of SH2B3, IL7r,Jak1/2/3 );
ABL class( rearrangement of ABL1, ABL2, PDGFRA, PDGFRB, FGFR);
Other (NTRKr, FLT3r, LYNr, PTK2Br);
Intrachromosomal amplification of chromosome 21 (IAMP21-ALL);
t (17;19) : TCF3-HLF fusion ;
Alterations of IKZF1; E) Extramedullary lesions.
The expected survival time is ≥12 weeks;
ECOG score 0-1;
Had good organic function during screening
CD19 was still expressed in leukemia cells in bone marrow, peripheral blood orbiopsy tissue by flow cytometry within one month prior to informed consent (afterthe last treatment).
Exclusion
Exclusion Criteria:
Allergic to preconditioning measures.
Patients with other malignancies other than B-cell malignancies within 5 years priorto screening. Patients with cured skin squamous carcinoma,basal carcinoma,non-primary invasive bladder cancer, localized low-risk prostate cancer, in situcervical/breast cancer can be recruited.
Uncontrollable bacterial, fungal and viral infection during screening.
Patients had pulmonary embolism within 3 months prior to enrollment.
Had intolerant severe cardiovascular and cerebrovascular diseases and hereditarydiseases prior to enrollment.
Imaging confirmed the presence of central nervous system involvement (both primaryand secondary) and obvious symptoms at the time of screening.
Active HBV or HCV or HIV or Syphilis infection. HBV-DNA < 2000 IU/mL can beenrolled, but should admitted to use anti-virus drugs such as entecavir, tenufovir,etc, and supervisory the relative indication during the treatment.
Combined systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior toscreening. Or systemic diseases that require long-term use of immunizationInhibitor.
Vaccinated with influenza vaccine within 2 weeks prior to cleansing (SARS-COV19 canbe included, inactivated, live/non-live adjuvant vaccinations allowed to beincluded) .
Patients who are receiving GvHD treatment; Patients without GvHD and who had stoppedimmunosuppressive drugs for at least 1 month were eligible for inclusion.
Women who are in pregnant or lactating, and female subjects or partners who plan tobe pregnant within 1 year after cell infusion. Male subjects who plan pregnancywithin 1 year after infusion.
Any ineligibility conditions considered by the investigator that may increase therisk of the subject or interfere with the results of the study;
Study Design
Connect with a study center
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang
ChinaActive - Recruiting
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