Clinical trial · Interventional
Safety and Clinical Activity of ThisCART22 in Patients With r/r Non-Hodgkin's B Cell Lymphoma
An Open and Single Dose-escalation Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD22(ThisCART22) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma (r/r B-NHL)
NCT05106946CI-TRIAL-00055004unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART22 (Allogeneic CAR-T targeting CD22) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Malignancy | B-Cell Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ThisCART22 cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ThisCART22 cells injections
- description
- 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.
- interventionNames
- Biological: ThisCART22 cells
Primary outcomes (1)
- measure
- Treatment related adverse events
- timeFrame
- 90 days post infusion
- description
- Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0
Secondary outcomes (4)
- measure
- Overall Remission Rate (ORR)
- timeFrame
- up to 90 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-70 years old, no gender and race limited; 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: 1. Women in pregnancy or lactation; 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.
References
Publications (0)
Data not yet available
No reference posted for this study.