OncoMatch/Clinical Trials/NCT04684147
Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia
Is NCT04684147 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies single dose of CNCT19 for relapsed or refractory acute lymphoblastic leukemia.
Treatment: single dose of CNCT19 — The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 expression (demonstrated in bone marrow or peripheral blood within 3 months of study entry)
Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months of study entry
Excluded: ABL1 T315I
no TKI salvage treatments if the patient has a T315I mutation
Allowed: ABL1 BCR-ABL1 fusion
Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 generation of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a T315I mutation.
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: car-t cell therapy
Lab requirements
Blood counts
INR ≤ 1.5 ULN and APTT ≤ 1.5 ULN
Kidney function
Serum creatinine ≤ 1.5 ULN or Creatine removal rate ≥ 60mL/min (Cockcroft and Gault)
Liver function
AST ≤ 3 ULN; ALT ≤ 3 ULN; Total bilirubin ≤ 2 ULN, except in individuals with Gilbert's syndrome (bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN)
Cardiac function
Must have a minimum level of pulmonary reserve as ≤ Grade 1 dyspnea and oxygen saturation > 91% on room air
Adequate organ function defined as: AST ≤ 3 ULN; ALT ≤ 3 ULN; Total bilirubin ≤ 2 ULN, except in individuals with Gilbert's syndrome; Serum creatinine ≤ 1.5 ULN or Creatine removal rate ≥ 60mL/min; Must have a minimum level of pulmonary reserve as ≤ Grade 1 dyspnea and oxygen saturation > 91% on room air; INR ≤ 1.5 ULN and APTT ≤ 1.5 ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04684147 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior car-t cell therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 expression is a required biomarker for enrollment.
Are patients with ABL1 alterations eligible?
No. ABL1 T315I is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 65 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages