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

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

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

Study Overview

• Status: Recruiting
• Conditions: Relapsed or Refractory B-cell Lymphoma
• Intervention / Treatment: Drug: Relma-cel

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.

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Weili Zhao, professor; Phone Number: +86 021-64370045; Email: zwl_trial@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • NO.197， Ruijin Er Road
      • Contact: Weili Zhao, doctorate; Phone Number: +86 021-64370045; Email: zwl_trial@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Relma-cel secondary infusion	Drug: 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 Names: JWCAR029

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months post CAR-T infusion

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: JWCAR029019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No