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

NCT05814848 | Not Yet Recruiting Phase 4

• 1 other identifier: JWCAR029019
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Relapsed or Refractory B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  three months

Study Arms (1)

single arm

EXPERIMENTAL

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.

Drug: Relmacabtagene Autoleucel Injection

Interventions

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.

Also known as: CARTEYVA

single arm

Eligibility Criteria

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

You may qualify if:

• 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
• grade 3b follicular lymphoma
• primary mediastinal large B-cell lymphoma
• high-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangements (double/triple hit lymphoma)
• adult follicular lymphoma refractory to second-line or later systemic therapy or relapsed within 24 months Adult patients who had completed the first treatment with remifentanil injection;
• The patient had undergone at least one post-treatment disease assessment with Relmacabtagene Autoleucel Injection, and the investigator decided to retreat the patient (including PR\\PD\\SD) with commercially available Relmacabtagene Autoleucel injection based on clinical practice;
• Prior to the second infusion, an adequate dose of the manufactured product (80-150x106 CAR-T cells recommended) should be confirmed, at the investigator's discretion based on the patient's condition and dose stockpile；
• Confirmation of residual tumor tissue CD19+ in patients, if clinically permissible；
• Absence of antidrug antibody (ADA) to ricciolenz in plasma before retreatment；
• Toxicity associated with lymphocyte-clearing chemotherapy (fludarabine and cyclophosphamide), with the exception of alopecia, that resolved to ≤ grade 1 or returned to pre-first treatment levels before retreatment.
• The patients did not have serious adverse reactions during the first treatment, or the adverse reactions during the first treatment had resolved to the baseline level of the first treatment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

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

Study Officials

• Li Chen

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Chen

CONTACT

+8615026562366; yuhe0628@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: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 18, 2023
• Study Start: June 20, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share