Safety and Clinical Activity of ThisCART22 in Patients With r/r Non-Hodgkin's B Cell Lymphoma
NCT ID: NCT05106946
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2021-10-25
2024-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ThisCART22 cells injections
In this study, allogeneic anti-CD22 CAR T Cells(ThisCART22 cells) is used to treat patients with refractory or relapsed CD22 positive B cell malignancies.
ThisCART22 cells
0.2-60 x 10\^6 CAR T cells per kg body weight
Interventions
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ThisCART22 cells
0.2-60 x 10\^6 CAR T cells per kg body weight
Eligibility Criteria
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Inclusion Criteria
2. Estimated life expectancy \> 12 weeks deemed by investigator；
3. CD22 were positive by histopathology and/or cytology diagnosis；
4. Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)；
5. Relevant indicators for disease or assessment within 4 weeks after the last treatment;
6. Quality of Life Score (KPS) \>50%；
7. Subject has adequate organ function at screening, cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO); serum ALT/ AST \<3 upper limit of normal (ULN); bilirubin\<2.0 mg/dl; serum creatinine ≤1.6 mg/dl and/or BUN ≤ 1.5 mg/dl;
8. No remission or relapse after hematopoietic stem cell transplantation or autologous somatic immunotherapy;
9. Unsuitable conditions for stem cell transplantation;
10. Signed informed consent form (ICF).
Exclusion Criteria
2. In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection；
3. The absolute count of nonprimary neutrophil \< 0.75×10\^9/L or platelet count \< 50×10\^9/L;
4. Abnormal vital signs and failure to cooperate with examination;
5. Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation;
6. Highly allergic constitution or history of severe allergy;
7. Patients with systemic infection or severe local infection requiring anti-infection treatment;
8. Patients with severe autoimmune diseases;
9. Presence of any other conditions that are unsuitable for this study as judged by the investigator.
18 Years
70 Years
ALL
No
Sponsors
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The Affiliated Hospital of Xuzhou Medical University
OTHER
Fundamenta Therapeutics, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Zhenyu Li, Ph.D
Role: STUDY_CHAIR
The Affiliated Hospital of Xuzhou Medical University
Locations
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The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Zhenyu Li
Role: primary
Other Identifiers
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FT402-002
Identifier Type: -
Identifier Source: org_study_id