Nanobody-Based CD19/CD22 Tandem Dual CAR-T Therapy for R/R B-ALL

Required: CD19 positivity

Required: CD22 positivity

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.