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
Qualifiers
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
Treatments tested in this trial
- Autoleucel (Relmacabtagene Autoleucel)
- Sintilimab (PD-1 inhibitor)
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Sun Yat-sen University
Lead sponsor
Fifth Affiliated Hospital of Guangzhou Medical University
Collaborator
Guangzhou Overseas Chinese Hospital,Guangdong
Collaborator
Source ClinicalTrials.gov