To Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With MRD Positive Acute B-cell Leukemia

Zhejiang University1 site in 1 country16 target enrollmentMarch 18, 2022

ConditionsB-ALL

Overview

This is an open label, phase I study to assess the safety, efficacy and pharmacokinetics of ThisCART19A in patients with MRD+ B-ALL

Registry

clinicaltrials.gov

Start Date

March 18, 2022

End Date

April 30, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Sponsor

Zhejiang University

Responsible Party

Principal Investigator

He Huang

President/Proffessor

Zhejiang University

•Inclusion Criteria:
•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 18-65 (upper limit not included);
•Disease status ≥CR2 with bone marrow flow cytometry MRD≥0.1%.
•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 expected survival time is ≥12 weeks;
•ECOG score 0-1;
•Had good organic function during screening
•CD19 was still expressed on leukemia cells in bone marrow, peripheral blood or biopsy tissue by flow cytometry, results within one month prior to informed consent are acceptable (after the last treatment).

•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.
•\< 100 days after hematopoietic stem cell transplantation.
•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) .

The incidence of all grade TEAEs and ≥3 grade TEAEs

Time Frame: Up to 2 years after ThisCART19A infusion

Incidence of treatment-emergent adverse events (TEAEs) and ≥3 grade TEAEs

Dose-limiting toxicity (DLT)

Time Frame: Up to 28 days after ThisCART19A infusion

DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.

Relapse-Free Survival(24 months)
The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion(3 months)
Changes in immune effect cells count after ThisCART19A infusion.(3 months)
MRD response rate(At Month 1, 2, 3)
Changes in cytokine level after ThisCART19A infusion.(3 months)