OncoMatch/Clinical Trials/NCT04532268
A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL
Is NCT04532268 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies Humanized CD19 CAR-T cells for acute lymphoblastic leukemia.
Treatment: Humanized CD19 CAR-T cells — A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive
CD19+ B-ALL
Required: CD19 positive
Relapsed or refractory B-NHL
Required: BCR negative
Philadelphia-chromosome-negative (Ph-) patients
Allowed: BCR fusion
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)
Demographics
Prior therapy
Must have received: chemotherapy
Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions): CR not achieved after standardized chemotherapy; CR achieved following the first induction, but CR duration is less than 12 months; Ineffectively after first or multiple remedial treatments; 2 or more relapses
Must have received: chemotherapy
Relapsed or refractory B-NHL (meeting one of the following conditions): No response or relapse after second-line or above chemotherapy regimens; Primary drug resistance; Relapse after auto-HSCT
Cannot have received: CAR-T cell therapy
Previously treated with any CAR-T cell product or other genetically-modified T cell therapies
Lab requirements
Kidney function
creatinine ≤ 176.8 umol/l
Liver function
total bilirubin ≤ 51 umol/l, alt and ast ≤ 3 times of upper limit of normal
Cardiac function
echocardiogram shows left ventricular ejection fraction (lvef) ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04532268 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 positive is a required biomarker for enrollment.
Does this trial require CD19?
Yes, CD19 positive is a required biomarker for enrollment.
Does this trial require BCR?
Yes, BCR negative is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger and at least 3 years old.
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 qualify