OncoMatch/Clinical Trials/NCT06880913
Nanobody-Based CD19/CD22 Tandem Dual CAR-T Therapy for R/R B-ALL
Is NCT06880913 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies Nanobody-Based CD19/CD22 Tandem Dual CAR-T for precursor b-cell lymphoblastic leukemia-lymphoma.
Treatment: Nanobody-Based CD19/CD22 Tandem Dual CAR-T — To evaluate the efficacy and safety of Nanobody-Based CD19/CD22 Tandem Dual Chimeric Antigen Receptor (CAR) T-cell therapy in patients with relapsed or refractory B-ALL
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positivity
Required: CD22 positivity
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: immunotherapy (blinatumomab, inotuzumab ozogamicin) — relapsed/refractory B-ALL
Eligibility for Phase II (RP2D) is restricted to patients with R/R B-ALL who have failed prior immunotherapies, including blinatumomab, inotuzumab ozogamicin, or prior single-target CAR-T therapy.
Must have received: CAR-T cell therapy — relapsed/refractory B-ALL
Eligibility for Phase II (RP2D) is restricted to patients with R/R B-ALL who have failed prior immunotherapies, including blinatumomab, inotuzumab ozogamicin, or prior single-target CAR-T therapy.
Cannot have received: investigational drug therapy
Receipt of any investigational drug therapy or other systemic antitumor therapy within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is longer, as determined by the investigator).
Cannot have received: systemic antitumor therapy
Receipt of any investigational drug therapy or other systemic antitumor therapy within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is longer, as determined by the investigator).
Cannot have received: radiation therapy
Exception: palliative radiotherapy for non-target lesions within 2 weeks before signing the ICF or as expected during the study
Receipt of extensive radiotherapy within 4 weeks prior to signing the ICF, except for palliative radiotherapy for non-target lesions within 2 weeks before signing the ICF or as expected during the study.
Lab requirements
Kidney function
Adults: creatinine clearance ≥60 mL/min or creatinine ≤1.5× ULN; Children: age/sex-specific creatinine thresholds
Liver function
AST and ALT ≤5× ULN; total bilirubin ≤2× ULN
Cardiac function
QTc <480 ms (Fridericia); LVEF ≥50%; NYHA <II; no unstable angina/MI within 6 months; no poorly controlled hypertension; no significant arrhythmias
Adequate organ function, meeting the following laboratory criteria: ... see full criteria for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06880913 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational drug therapy, systemic antitumor therapy, radiation therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positivity is a required biomarker for enrollment.
Does this trial require CD22?
Yes, CD22 positivity is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 65 years or younger and at least 12 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