Status:
RECRUITING
To Observe the Dual-target Chimeric Antigen Receptor T Cells in the Treatment of B Cell Hematologic Tumors
Lead Sponsor:
Hebei Senlang Biotechnology Inc., Ltd.
Collaborating Sponsors:
Hebei Taihe Chunyu Biotechnology Co., Ltd
Conditions:
19 and 22+ B Cell Hematologic Tumors
19 and 20+ B Cell Hematologic Tumors
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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).
Detailed Description
This study is open single-arm prospective clinical study To relapse/refractory blood B cell tumor patients as the subjects, according to the expression of tumor cells, gives the corresponding double t...
Eligibility Criteria
Inclusion
- 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;
- Estimated survival time\>3 months; 5.ECOG Scores: 0\~2; 6.There should be at least one measurable tumor foci according to RECIST Version 1.1; 7.The functions of vital organs must meet the following conditions: EF\>50%, and no obvious abnormality of electrocardiogram; SpO2≥92%; Cr≤1.5ULN; ALTand AST≤5ULN, TBil≤3ULN; 8.Subjects planning to become pregnant must agree to use contraception prior to enrolling in the study and after six months of study duration; inform the investigator immediately if the subject becomes pregnant or suspects pregnancy; 9.The subject or guardian understands and signs the informed consent.
Exclusion
- 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;
- Known positive serology for human immunodeficiency virus (HIV) or syphilis;
- A history of severe allergies to biological products (including antibiotics);
- Patients with relapses after allogeneic hematopoietic stem cell transplantation with grade 3-4 acute graft-versus-host disease (GvHD);
- Female patients who are under pregnancy and/or lactation;
- Active autoimmune disease requiring systemic immunosuppressive therapy;
- Conditions that the investigator believes may increase the risk to the subject or interfere with the results of the study.
Key Trial Info
Start Date :
April 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05388695
Start Date
April 8 2022
End Date
May 30 2027
Last Update
June 18 2025
Active Locations (1)
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1
Tongji Hospital
Wuhan, Hubei, China