Clinical trial · Interventional
Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphoma
A Clinical Study on the Safety and Effectiveness of Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphoma
NCT06633341CI-TRIAL-00081418recruitingEarly Phase 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 Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-lymphoma
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 |
|---|---|---|---|
| T-lymphoblastic Lymphoma | T Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD5 CAR T-cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Administration of CD5+ T-lymphoma Targeted CAR T-cells
- description
- Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
- interventionNames
- Biological: CD5 CAR T-cells
Primary outcomes (2)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- Up to 28 days after Treatment
- description
- Adverse events assessed according to NCI-CTCAE v5.0 criteria
- measure
- Incidence of treatment-emergent adverse events (TEAEs)
- timeFrame
- Up to 2 years after Treatment
- description
- Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 1\. According to the 2016 WHO classification of lymphocyte tumors, histologically confirmed CD5-positive T-cell non-Hodgkin lymphoma (T-NHL), R/R T-NHL(meets one of the following conditions) : 1. Subjects did not go into remission or relapse after receiving second-line or more chemotherapy regiments; 2. Primary drug resistance; 3. Relapse after autologous hematopoietic stem cell transplantation; * 2.CD5 expression rate was \>90%; * 3\. According to Lugano 2014, there should be at least one evaluable tumor lesion; * 4\. Total bilirubin ≤51 (mol/L), Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/L); * 5\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%; * 6\. Refers to the pulse oxygen saturation 92% or higher oxygen (state); * 7\. Estimated life expectancy of minimum of 12 weeks; * 8\. ECOG 0-2; * 9\. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period; * 10\. Those who voluntarily participated in this trial and provided informed consent; Exclusion Criteria: * 1\. History of epilepsy or other central nervous system disorders; * 2\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; * 3\. Active infection of hepatitis B virus, C virus or hepatitis E virus; * 4\. Active infected persons who are not cured; * 5\. Before using any gene therapy products; * 6\. Received anti-tumor therapy before infusion, should meet the following any one should be ruled out: 1. treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone \< 10 mg/d or an equivalent dose of the drug); 2. received within 72 hours of small molecule targeted therapy; 3. 2 weeks received systemic chemotherapy except (pretreatment); 4. four weeks received radiotherapy; * 7\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; * 8\. Any unsuitable to participate in this trial judged by the investigator; * 9\. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.
References
Publications (0)
Data not yet available
No reference posted for this study.