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Trial Title:
A Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma
NCT ID:
NCT05814848
Condition:
Relapsed or Refractory B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Relmacabtagene Autoleucel Injection
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.
Arm group label:
single arm
Other name:
CARTEYVA
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Informed Consent Form (ICF) was obtained from the patients.
- Diagnosed relapsed or refractory B-cell lymphomas
1. diffuse large B-cell lymphoma-not otherwise specified
2. diffuse large B-cell lymphoma transformed from follicular lymphoma
3. grade 3b follicular lymphoma
4. primary mediastinal large B-cell lymphoma
5. high-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangements
(double/triple hit lymphoma)
6. 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 20, 2023
Completion date:
March 31, 2028
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05814848
