CompletedPhase 1

Evaluate the Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With R/R B-ALL

China10 participantsStarted 2022-03-18

Plain-language 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

Who can participate

Age range18 Years – 70 Years

SexALL

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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 18-70(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 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 criteria

✕. 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.

What they're measuring

Dose limited toxicity(DLT) observation and the incidence of treatment-emergent adverse events(TEAE) which more than or equal to grade 3 in each dose level

Timeframe: 28 days

The incidence of all grade TEAEs and ≥3 grade TEAEs

Timeframe: Up to 2 years after ThisCART19A infusion

Trial details

NCT IDNCT05350787

SponsorZhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-21

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