Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Clinical Study of ET019002-T Cell Therapy for Refractory/Relapsed B-Cell Malignancies

Summary: This study is to determine the safety, including potential dose limiting toxicities, and efficiency of ET019002-T cells and the duration of in vivo survival of ET019002-T cells in patients with relapsed/refractory B-Cell Malignancies.

Detailed description: ET019002-T cell therapy is a novel chimeric T-cell therapy platform that in preclinical studies, functionally matches the efficacy of CAR-T cells, but dramatically reduces the release of cytokines upon killing of target-positive tumors.The arm of the study is experimental i.v. arm:ET019002-T cells administered by intravenous (IV) infusion.The intervention is ET019002-T cells(Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET019002)-expression construct).

Eligibility: Inclusion Criteria:
  -  Diagnosed B cell malignancies including: B-cell Acute Lymphoblastic Leukemia (B-ALL) and B cell lymphomas (DLBCL、FL、MZL、LPL、HCL、CLL、BL、MCL)
  -  Refractory/Relapsed B cell malignancies:
  -  Age 6-80 years, male or female
  -  Nidus could be evaluated: minimum diameter of single nidus ≥10mm, and/or tumor cells in bone marrow ≥ 5%
  -  ECOG≤2 points
  -  Function of main organs or tissues were functional: Liver - ALT/AST≤3 normal upper limit, Serum total bilirubin (TBIL) ≤2 normal upper limit; Kidney - glomerular filtration rate (GFR) > 60 mL/min/1.73 m2 or serum creatinine in normal range; Lunge - carbon monoxide diffusion capacity (DLCO) or forced expiratory volume in 1s (FEV) >45% estimate; Heart - left ventricular ejection fraction (LVEF) ≥50%
  -  Expecting life span ≥3 months
  -  No chemotherapy, radiation therapy or immunotherapy in 2 weeks before enrollment
  -  Fertile females/males consented to use contraceptives during participation of the trial
  -  Patient or his/her custodia could understand and is willing to sign the written consent
  Exclusion Criteria:
  -  Pregnancy or lactation
  -  Couldn't use contraceptives during participation of the trial
  -  Couldn't collect enough monocyte
  -  Active and/or severe infection
  -  HIV infection, active Hepatitis B or Hepatitis C infection
  -  Had active autoimmune disease
  -  Had non-melanoma skin carcinoma (NMSC) or Carcinoma in situ (e.g. cervix, bladder, galactophore)
  -  Obvious clinical encephalopathy or novel neuron function damage
  -  Organ failure: Heart - upper than NYHA level III or had uncontrolled malignant arrhythmia; Liver - upper than level III of Wuhan conference classification; Kidney - kidney failure stage3 or worse
  -  Using immunosuppressive drugs or adreno-cortical hormone (ACH) within two weeks of enrollment
  -  Insufficient T cell number or T cell transfection rate
  -  Needed urgent disease controlling due to tumor load
  -  Patients had biological treatment, immunotherapy or radiation therapy within 6 weeks prior to enrollment or are currently under these treatment
  -  Substance abuse or drug addiction
  -  lack of compliance, communication deficit or other unaccommodated situations

Relevance to patient case: not relevant