Clinical trial · Interventional
Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies
A Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD7 in Patients With Refractory or Relapsed T Cell Malignancies
NCT05127135CI-TRIAL-00055117unknownPhase 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)
This is a single dose escalation study to evaluate the safety and clinical activity of ThisCART7(Allogeneic CAR-T targeting CD7) in patients with refractory or relapsed CD7 positive T cell malignancies.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| T-Acute Lymphoblastic Leukemia | T Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| T-cell Acute Lymphoblastic Lymphoma | — | UNRESOLVED | — |
| T-cell Non-Hodgkin Lymphoma | T-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ThisCART7 cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ThisCART7 cells injections
- description
- In this study, allogeneic anti-CD7 CAR T Cells(ThisCART7 cells) is used to treat patients with refractory or relapsed CD7 positive T cell malignancies.
- interventionNames
- Biological: ThisCART7 cells
Primary outcomes (1)
- measure
- Incidence of Treatment-related grade≥3Adverse Events or SAE
- timeFrame
- within 4 weeks after infusion
- description
- Therapy-related adverse events or SAE will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Secondary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed with relapsed and refractory CD7 + T cell hematologic malignancies (including, but not limited to, T-cell leukemia, extranodal NK/ T-cell lymphoma nasal, peripheral T-cell lymphoma, enteropathy associated T-cell lymphoma and anaplastic T-cell lymphoma, etc.); 2. No alternative treatment options deemed by investigator; 3. Measurable or detectble disease at time of enrollment; 4. Age 18-70 years old, no gender and race limited; 5. Eastern cooperative oncology group (ECOG) performance status of ≤2; 6. Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO); 7. Estimated life expectancy \> 12 weeks deemed by investigator; 8. Serum creatinine ≤ 1.5 upper limit of normal (ULN); 9. Serum ALT/ AST ≤ 5 upper limit of normal (ULN); 10. Signed informed consent form (ICF). Exclusion Criteria: 1. Women in pregnancy or lactation; 2. Uncontrolled infection; 3. Active hepatitis B virus or hepatitis C virus infection; 4. Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease; 5. Prior treatment with an allogeneic stem cell transplant within 100 days; 6. Grade 2-4 Active graft versus host disease; 7. History of HIV infection; 8. With central nervous system involvement; 9. Patients combine with other disease cause neutrophil count (ANC) \< 750/uL or PLT\< 50,000/uL.
References
Publications (0)
Data not yet available
No reference posted for this study.