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

Last updated: April 26, 2022
Sponsor: Zhejiang University
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05350787
FT400-004
  • Ages 18-64
  • All Genders

Study 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

Inclusion Criteria:

  1. All subjects or legal representatives must sign a voluntary letter of consent approvedby the IRB in person prior to the commencement of any screening procedure;
  2. Patients diagnosed with B-ALL according to the Chinese Guidelines for the Diagnosisand Treatment of Adult Acute Lymphoblastic Leukemia (2021 edition);
  3. There is no gender limitation, age 18-65 (upper limit not included);
  4. 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 after hematopoieticstem cell transplantation; D) high-risk patients (High risk was defined as a highwhite 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.
  1. The expected survival time is ≥12 weeks;
  2. ECOG score 0-1;
  3. Had good organic function during screening
  4. CD19 was still expressed in leukemia cells in bone marrow, peripheral blood or biopsytissue by flow cytometry within one month prior to informed consent (after the lasttreatment).

Exclusion

Exclusion Criteria:

  1. Allergic to preconditioning measures.
  2. Patients with other malignancies other than B-cell malignancies within 5 years priorto screening. Patients with cured skin squamous carcinoma,basal carcinoma, non-primaryinvasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breastcancer can be recruited.
  3. Uncontrollable bacterial, fungal and viral infection during screening.
  4. Patients had pulmonary embolism within 3 months prior to enrollment.
  5. Had intolerant severe cardiovascular and cerebrovascular diseases and hereditarydiseases prior to enrollment.
  6. Imaging confirmed the presence of central nervous system involvement (both primary andsecondary) and obvious symptoms at the time of screening.
  7. 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, andsupervisory the relative indication during the treatment.
  8. Combined systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior toscreening. Or systemic diseases that require long-term use of immunization Inhibitor.
  9. Vaccinated with influenza vaccine within 2 weeks prior to cleansing (SARS-COV19 can beincluded, inactivated, live/non-live adjuvant vaccinations allowed to be included) .
  10. Patients who are receiving GvHD treatment; Patients without GvHD and who had stoppedimmunosuppressive drugs for at least 1 month were eligible for inclusion.
  11. Women who are in pregnant or lactating, and female subjects or partners who plan to bepregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1year after infusion.
  12. Any ineligibility conditions considered by the investigator that may increase the riskof the subject or interfere with the results of the study;

Study Design

Total Participants: 16
Study Start date:
March 18, 2022
Estimated Completion Date:
April 30, 2024

Connect with a study center

  • The First Hospital of Zhejiang Medical Colleage Zhejiang University

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • The first affiliated hospital of medical college of zhejiang university

    Hangzhou, Zhejiang
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.