OncoMatch/Clinical Trials/NCT04227015
A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy
Is NCT04227015 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies CTA101 for acute lymphoblastic leukemia.
Treatment: CTA101 — A study of CTA101 UCAR-T cell injection in patients with relapsed or refractory CD19+ B-line hematological malignancy
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive
CD19+ B-ALL
Required: HLA antibody negative OR donor specific antibody negative
HLA antibody(-) or HLA antibody(+) and HLA donor specific antibody(DSA)(-)
Allowed: BCR Philadelphia chromosome
Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: car-t cell therapy
Lab requirements
Kidney function
creatinine ≤ 176.8umol/L
Liver function
total bilirubin ≤ 51umol/L, ALT and AST ≤ 3 times of upper limit of normal
Cardiac function
Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%; NYHA cardiac function classification grade III or IV cardiac insufficiency [excluded]; Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment [excluded]; Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999) [excluded]; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past [excluded]
total bilirubin ≤ 51umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8umol/L; Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%; NYHA cardiac function classification grade III or IV cardiac insufficiency [excluded]; Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment [excluded]; Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999) [excluded]; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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