Status:
RECRUITING
Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With R/R B-ALL
Lead Sponsor:
Zhejiang University
Conditions:
B-ALL
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is an open label, phase I study to assess the safety, efficacy and pharmacokinetics of ThisCART19A in patients with relapsed and refractory acute B-cell leukemia
Eligibility Criteria
Inclusion
- All subjects or legal representatives must sign a voluntary letter of consent approved 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 Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2021 edition);
- There is no gender limitation, age 18-70(upper limit not included);
- Consistent with the diagnosis of recurrent refractory B-ALL. Recurrence： was defined as the recurrence of lymphoblasts（≥5%） in peripheral blood or bone marrow or extramedullary diseasefor patients who had acquired CR ; Refractory ：was defined as failure to CR or CRi at the end of induction therapy (generally referred to 4-week regimen or Hyper-CVAD regimen);Patients with Ph+ R/R ALL who failed after 2-line TKI treatment, 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 auto car-T/berintoomumab/ CD22 antibody conjugation drugs; C) ≥100 days after hematopoietic stem cell transplantation; D) high-risk patients (High risk was defined as a high white blood cell count ≥30×109/L at diagnosis or with poor cytogenetic 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 or biopsy tissue by flow cytometry within one month prior to informed consent (after the last treatment).
Exclusion
- Allergic to preconditioning measures.
- Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma,basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/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 hereditary diseases prior to enrollment.
- Imaging confirmed the presence of central nervous system involvement (both primary and secondary) and obvious symptoms at the time of screening.
- Active HBV or HCV or HIV or Syphilis infection. HBV-DNA \< 2000 IU/mL can be enrolled, 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 to screening. Or systemic diseases that require long-term use of immunization Inhibitor.
- Vaccinated with influenza vaccine within 2 weeks prior to cleansing (SARS-COV19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included) .
- Patients who are receiving GvHD treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion.
- Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.
- Any ineligibility conditions considered by the investigator that may increase the risk of the subject or interfere with the results of the study;
Key Trial Info
Start Date :
March 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05350787
Start Date
March 18 2022
End Date
August 30 2025
Last Update
July 16 2025
Active Locations (2)
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1
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China, 310003
2
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China