This study aims to collect efficacy and safety data from adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) who receive a second infusion of relma-cel injection after initial treatment with relma-cel. The study will not include any form of grouping, and subgroup analysis will be conducted based on the actual data collected.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients have signed an Informed Consent Form (ICF).
Adults diagnosed with relapsed or refractory B-cell lymphoma who have completed initial treatment with Relma-cel.
Patients must have undergone at least one disease assessment post-initial Relma-cel treatment, and the investigator decides to administer a second treatment (including PR/PD/SD) based on clinical practice.
Before the second infusion, confirm that the prepared dose of relma-cel is sufficient (recommended 80-150 x 10\^6 CAR-T cells), with specific dosage determined by the investigator based on patient condition and dose availability.
Confirm the presence of CD19+ residual tumor tissue, if clinically permissible.
Measure plasma for the absence of anti-drug antibodies (ADA) to relma-cel before the second treatment.
Toxicity related to lymphodepleting chemotherapy (fludarabine and cyclophosphamide), except for hair loss, must have resolved to ≤ Grade 1 or returned to baseline levels before retreatment.
Patients must not have experienced severe adverse reactions during the first treatment, or any adverse reactions must have resolved to baseline levels from the first treatment.
You may not be if
Patients with hypersensitivity to active ingredients or any excipients (e.g., dimethyl sulfoxide, compound electrolyte injection, human albumin).
Patients with uncontrolled systemic fungal, bacterial, viral, or other infections
Clareo Health | Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma
