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

Primary Purpose

Relapsed or Refractory B-cell Lymphoma

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Relmacabtagene Autoleucel Injection
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory B-cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • NO.197, Ruijin Er RoadRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 28, 2023
Last Updated
July 27, 2023
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05806580
Brief Title
Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma
Official Title
A Single-arm Prospective Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
CD19-targeted chimeric antigen receptor T-cell therapy has shown remarkable efficacy in relapsed or refractory B-cell malignancies. However, CD19 CAR-T cells are still unable to induce durable remissions in some patients. Further therapeutic strategies remain to be explored for patients who fail to achieve complete remission (CR) or who relapse after CAR-T treatment. the mechanisms underlying the failure of CAR-T cell therapy may be diverse and not yet fully understood. It may be due to the patient's own poor T-cell function, immunosuppressive tumour microenvironment, loss of tumour-targeting antigen expression with antitumour therapy, and compromised CAR-T renewal in vivo, or T-cell depletion due to the tumour microenvironment. It has recently been demonstrated that CAR-T cells become functionally depleted, or CAR lost, with sustained exposure to tumour antigen stimulation (Good, C, 2021). Extensive clinical experience suggests that CAR-T cell expansion and persistence are required to achieve a durable response. In patients requiring follow-up therapy after failure of the first CAR-T cell infusion (CART1), one option is a second infusion of CD19 CAR-T cells (CART2) for retreatment, and a second infusion of CD19 CAR-T cells (CART2) is considered a possible approach to improve prognosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory B-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Relmacabtagene Autoleucel Injection
Other Intervention Name(s)
JWCAR029
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
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.
Time Frame
secondary infusion after three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
weili Zhao, Doctoral
Phone
+86 021-64370045
Email
zwl_trial@163.com
Facility Information:
Facility Name
NO.197, Ruijin Er Road
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, doctorate
Phone
+86 021-64370045
Email
zwl_trial@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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