Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma
NCT ID: NCT05806580
Last Updated: 2024-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
8 participants
INTERVENTIONAL
2023-05-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Relma-cel secondary infusion
Relma-cel
Patients 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.
Interventions
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Relma-cel
Patients 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 uncontrolled systemic fungal, bacterial, viral, or other infections
18 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
Vice president，Ruijin hospital
Locations
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NO.197， Ruijin Er Road
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JWCAR029019
Identifier Type: -
Identifier Source: org_study_id
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