Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma

Launched by RUIJIN HOSPITAL · Mar 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a second infusion of relma-cel, a type of treatment for patients with relapsed or refractory B-cell lymphoma, which means their cancer has come back or did not respond to previous treatments. The researchers want to see how well this second dose works and how safe it is for patients who have already received the treatment once before. The trial is currently looking for adult participants, aged 65 to 74, who have completed their first treatment with relma-cel and have shown some signs of their disease after that treatment.

To be eligible for the trial, patients must agree to participate and have a confirmed diagnosis of B-cell lymphoma. They should have had some assessment of their condition after the initial treatment and be deemed suitable for a second infusion by their doctor. Additionally, certain health criteria need to be met, such as having manageable side effects from previous treatment and no serious allergic reactions. Participants can expect close monitoring throughout the trial, including checks on their health and the effectiveness of the treatment. It’s important for potential participants to know that they should not have any serious infections or allergies to the treatment ingredients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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