OncoMatch/Clinical Trials/NCT07838714
Dual-Targeted Umbilical Cord Blood CAR-T Cells Against CD19 and CD22 for the Treatment of Relapsed or Refractory Acute B-Cell Lymphoblastic Leukemia
Official title: A Single-Center Phase I Clinical Trial of Dual-Targeted Umbilical Cord Blood CAR-T Cells Against CD19 and CD22 for the Treatment of Relapsed or Refractory Acute B-Cell Lymphoblastic Leukemia
Is NCT07838714 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments including Anti-CD19/CD22 Dual-Target Cord Blood CAR-T Cells and Fludarabine for b-cell acute lymphoblastic leukemia.
Treatment: Anti-CD19/CD22 Dual-Target Cord Blood CAR-T Cells · Fludarabine · Cyclophosphamide — This investigator-initiated, prospective, single-arm, phase I dose-escalation trial aims to evaluate the safety and tolerability of anti-CD19/CD22 dual-target cord blood-derived CAR-T cells in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia who have failed prior therapies, with the goal of reducing antigen-escape relapse and overcoming poor autologous T-cell fitness through the use of universally available umbilical cord blood T cells.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 expression
Required: CD22 expression
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: solid organ transplant
History of solid organ transplantation.
Lab requirements
Blood counts
ANC ≥1×10⁹/L; ALC ≥0.3×10⁹/L; platelet count ≥20×10⁹/L; hemoglobin ≥60 g/L.
Kidney function
creatinine clearance (CrCl) ≥40 mL/min (by Cockcroft-Gault formula).
Liver function
ALT and AST ≤2.5× ULN; total bilirubin ≤1.5× ULN.
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50%.
Adequate organ function at screening, meeting all of the following laboratory criteria: Hematology: ANC ≥1×10⁹/L; ALC ≥0.3×10⁹/L; platelet count ≥20×10⁹/L; hemoglobin ≥60 g/L. Hepatic function: ALT and AST ≤2.5× ULN; total bilirubin ≤1.5× ULN. Renal function: creatinine clearance (CrCl) ≥40 mL/min (by Cockcroft-Gault formula). Coagulation: fibrinogen ≥1.0 g/L; APTT ≤1.5× ULN; PT ≤1.5× ULN. Oxygen saturation >91%. Left ventricular ejection fraction (LVEF) ≥50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07838714 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior solid organ transplant disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 expression is a required biomarker for enrollment.
Does this trial require CD22?
Yes, CD22 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 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