A Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma

ConditionRelapsed or Refractory B-cell Lymphoma

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorChanghai Hospital

About this trial

To evaluate the efficacy and safety of post-marketing Regiorense injection secondary infusion in the treatment of adult patients with relapsed or refractory B-cell lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed Consent Form (ICF) was obtained from the patients.

Diagnosed relapsed or refractory B-cell lymphomas

diffuse large B-cell lymphoma-not otherwise specified

diffuse large B-cell lymphoma transformed from follicular lymphoma

Disqualifiers

Patients with hypersensitivity to the active ingredient or any excipients (dimethyl sulfoxide, compound electrolyte injection, human serum albumin);

Patients had uncontrolled systemic fungal, bacterial, viral, or other infections

Trial design

Design model

Single group

Treatments tested in this trial

Relmacabtagene Autoleucel Injection
Drug
For patients who had undergone at least one disease assessment after the first treatment of Relmacabtagene Autoleucel injection and whose disease status was not complete remission, the investigators decided to give the patients a second treatment of Relmacabtagene Autoleucel injection based on clinical practice, and the specific dosage was determined by the investigators according to the patient's condition and dose reserve.

Treatment groups

13 Participants

are divided into 1 treatment group

Group A: single armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Objective Response Rate

Objective Response Rate (ORR) : The investigator-assessed best disease status of patients with relapsed or refractory B-cell lymphoma was the rate of Complete Response (CR) or Partial Response (PR) at 3 months after a second infusion of remifolenafil.

Time frame

three months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changhai Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: