Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University
About this trial
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Relmacabtagene Autoleucel in combination with the Sintilimab regimen for the treatment of relapsed/refractory B-cell lymphoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient must be aware of and voluntarily sign the informed consent form (ICF).
Aged between 18 and 70 years, both male and female.
Pathologically diagnosed with DLBCL, FL, or MCL, with histological confirmation of CD19 positivity (immunohistochemistry or flow cytometry, with flow cytometry used for re-evaluation if immunohistochemistry is CD19-negative).
The patient must be willing to receive regorafenib and sintilimab treatment and be deemed suitable for this treatment by the investigator.
Disqualifiers
History of another malignancy that has not been in complete remission for at least 2 years, except for: non-melanoma skin cancer, completely resected stage I tumors with low recurrence potential, treated localized prostate cancer, biopsy-confirmed cervical carcinoma in situ, or squamous intraepithelial lesions detected by Pap smear and so on.
Active Hepatitis B: a) Positive for Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) , with HBV-DNA below the lower limit of the reference value can be included.
Hepatitis C, HIV, or syphilis infection.
Uncontrolled systemic fungal, bacterial, viral, or other infections.
Trial design
Design model
Single group
Treatments tested in this trial
Autoleucel (Relmacabtagene Autoleucel)
DrugRelmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion (fludarabine + cyclophosphamide).
Sintilimab (PD-1 inhibitor)
DrugPatients will receive intravenous Sintilimab (200 mg every 3 weeks) starting on Day 28 after reinfusion, continuing until disease progression or intolerable toxicity, with a maximum duration of 1 year.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Relmacabtagene Autoleucel in combination with SintilimabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The complete response rate (CRR) at 3 months
Time frame
Up to 3 months after Relmacabtagene Autoleucel infusionSecondary outcomes
1
Disease-free survival (DFS)
To investigate the preliminary anti-tumor efficacy
Time frame
From the date of the first complete response to the date of the first documented progression or death from any cause, whichever came first,assessed up to 24 months2
Progression-free survival (PFS)
To investigate the preliminary anti-tumor efficacy
Time frame
From the date of enrollment until the date of the first documented progression or death from any cause,whichever came first,assessed up to 24 months3
Overall survival (OS)
To investigate the preliminary anti-tumor efficacy
Time frame
From the date of enrollment until the date of death from any cause, assessed up to 24 months4
Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0
To identify the incidence of AE and SAE
Time frame
Through study completion, an average of 2 yearsOther outcomes
1
Investigating Immune Microenvironment, Proteomic, and Metabolomic Changes Associated with Treatment Efficacy Across Different Patient Group
To investigate the immune microenvironment changes, along with proteomic and metabolomic alterations, and correlate these variations with treatment efficacy across different patient groups.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sun Yat-sen University
Lead sponsor
Fifth Affiliated Hospital of Guangzhou Medical University
Collaborator
Guangzhou Overseas Chinese Hospital,Guangdong
Collaborator
Source ClinicalTrials.gov