Clinical trial · Interventional
CD4-specific CAR T Cells (CD4 CAR T Cells) for Relapsed/Refractory T Cell Malignancies
NCT04162340CI-TRIAL-00051895unknownPhase 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 phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD4 CAR T cells in patients with relapsed and/or refractory T cell lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory T-Cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| T Cell Lymphoma in Relapse | T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD4 CAR T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD4 CAR T cells
- description
- Dose escalation phase: CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells with an escalation approach, 2e6 to 5e6 CAR-T cells/kg
- interventionNames
- Biological: CD4 CAR T cells
Primary outcomes (1)
- measure
- Number of adverse events after CD4 CAR T cells cell infusion
- timeFrame
- 2 years particularly the first 28 days after infusion
- description
- Determine the toxicity profile of CD4 CAR T cell therapy
Secondary outcomes (4)
- measure
- Incidence of treatment-emergent adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent; Patients volunteer to participate in the research * Diagnosis is mainly based on the World Health Organization (WHO) 2008 * Patients have exhausted standard therapeutic options * Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks * Female must be not pregnant during the study Exclusion Criteria: * Patients declining to consent for treatment * Prior solid organ transplantation * Potentially curative therapy including chemotherapy or hematopoietic cell transplant * Any drug used for GVHD must be stopped \>1 week
References
Publications (0)
Data not yet available
No reference posted for this study.