To Observe the Dual-target Chimeric Antigen Receptor T Cells in the Treatment of B Cell Hematologic Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHebei Senlang Biotechnology Inc., Ltd.
About this trial
To observe the long-term efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory relapsed B cell hematologic tumors (at least 2 years).
Eligibility criteria
Qualifiers
Refractory and relapsed B-cell tumor determined by clinical diagnosis, B cell tumors include the following three categories: B cell acute lymphocyte leucocyte; Inert B cell lymphoma (CLL、 FL、 MZL); Aggressive B-cell lymphoma (DLBCL、 BL、 MCL);
CD19 positive and CD20 positive or CD22 positive were detected by immunohistochemistry or flow cytometry; 3.18 years old≤age≤70 years old;
Disqualifiers
With other diseases that are not effectively controlled, including, but not limited to, persistent or poorly controlled infections symptomatic congestive heart failure unstable angina arrhythmia poorly controlled pulmonary disease or psychiatric disease;
Presence of other malignant tumors;
There are severe infections that cannot be effectively controlled;
Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to exclude; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA positive in peripheral blood;
Trial design
Treatments tested in this trial
- Autologous CD19/CD22/CD20 Chimeric Antigen Receptor T-cells
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Hebei Senlang Biotechnology Inc., Ltd.
Lead sponsor
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborator
Source ClinicalTrials.gov