CD19/CD22 CAR-T as First-line Consolidation in Follicular Lymphoma
ConditionLymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorLiping Dou
About this trial
The purpose of this study is to determine the efficacy and safety of CD19/CD22 Chimeric Antigen Receptor (CAR) T-Cell immunotherapy as first-line consolidation therapy in patients with follicular lymphoma.
Eligibility criteria
Qualifiers
1. With the patient's consent and signed informed consent form, willing and able to comply with the planned visits, research treatments, laboratory tests, and other experimental procedures;
The patient's disease is still evaluated as partial response (PR) after induction treatment with standard first-line chemotherapy regimen, or
The patient's disease reaches complete response (CR) after induction treatment with standard first-line chemotherapy regimen, but there are high-risk factors at the time of onset;
Follicular Lymphoma International Prognostic Index (FLIPI-1) score of 3-5 or FLIPI-2 score of 3-5;
Disqualifiers
1. Have received any form of chimeric antigen receptor cell therapy or other genetically modified T cell therapy;
2. Has a history of severe immediate hypersensitivity reactions to aminoglycoside antibiotics and other essential medications;
HBV DNA quantification ≥ 2000 IU/ml;
ALT ≥ 2 times the normal upper limit value;
Trial design
Treatments tested in this trial
- CD22/CD19 CAR-T cell immunotherapy
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Liping Dou
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
Source ClinicalTrials.gov