Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
To observe the efficacy and safety of a second infusion of relma-cel injection in patients with relapsed or refractory B-cell lymphoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Relma-cel
DrugPatients who have undergone at least one disease assessment after initial Relma-cel treatment and have not achieved complete remission may receive a second treatment based on clinical practice. The specific dosage will be determined by the investigator according to the patient's condition and available dose reserves.
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: Relma-cel secondary infusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate
ORR is defined as the percentage of participants achieving either CR or partial response (PR) per the Lugano Classification as determined by study investigators
Time frame
3 months post CAR-T infusionSponsors and contacts
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Source ClinicalTrials.gov