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RecruitingNCT05806580Updated Oct 23, 2024

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

A Phase 4 interventional study of Relma-cel in Relapsed or Refractory B-cell Lymphoma, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-23.

Sponsored by Ruijin Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

To observe the efficacy and safety of a second infusion of relma-cel injection in patients with relapsed or refractory B-cell lymphoma.

Read the detailed description

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.

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Conditions studied

  • Relapsed or Refractory B-cell Lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 8 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    Relma-cel secondary infusion

    Drug: Relma-cel

Interventions

  • DrugRelma-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.

    Also known as: JWCAR029

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What researchers measure

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 infusion

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Study locations

1 of 1 sites recruiting
  • NO.197, Ruijin Er Road
    Shanghai, Shanghai 200025, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05806580
Lead sponsor
Ruijin Hospital
Responsible party
Zhao Weili (Vice president,Ruijin hospital, Ruijin Hospital) — Principal investigator
First posted
Apr 10, 2023
Start date
May 1, 2023
Primary completion
May 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 23, 2024

Study contacts

Weili Zhao, professor
Contact
zwl_trial@163.com
+86 021-64370045

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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