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

NCT05806580 | Recruiting Phase 4

• 1 other identifier: JWCAR029019
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed or Refractory B-cell Lymphoma

Outcome Measures

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

  3 months post CAR-T infusion

Study Arms (1)

Relma-cel secondary infusion

EXPERIMENTAL

Drug: Relma-cel

Interventions

Relma-cel DRUG

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

Relma-cel secondary infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

NO.197， Ruijin Er Road

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell

Interventions

relmacabtagene autoleucel

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Weili Zhao, professor

CONTACT

+86 021-64370045; zwl_trial@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president，Ruijin hospital

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)