Clinical trial · Interventional
Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies
NCT04594135CI-TRIAL-00050397CD5CAR-TunknownPhase 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 anti-CD5 CART cells in patients with relapsed and/or refractory T cell lymphoma or leukemia.
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 |
|---|---|---|---|
| T-cell Acute Lymphoblastic Leukemia | T Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| T-cell Non-Hodgkin Lymphoma | T-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-CD5 CAR T cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-CD5 CAR T cells
- description
- Experimental: anti-CD5 CAR T cells Dose escalation phase: anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells with an escalation approach, 1e6 to 5e6 CAR-T cells/kg
- interventionNames
- Drug: anti-CD5 CAR T cells
Primary outcomes (1)
- measure
- Number of adverse events after anti-CD5 CAR T cells cell infusion
- timeFrame
- 2 years particularly the first 28 days after infusion
- description
- Determine the toxicity profile of anti-CD5 CAR T cell therapy
Secondary outcomes (4)
- measure
- Incidence of treatment-emergent adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed written informed consent; Patients volunteer to participate in the research 2. Diagnosis is mainly based on the World Health Organization (WHO) 2008 3. Patients have exhausted standard therapeutic options 4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks 5. Female must be not pregnant during the study Exclusion Criteria: 1. Patients declining to consent for treatment 2. Prior solid organ transplantation 3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant 4. Any drug used for GVHD must be stopped \>1 week
References
Publications (0)
Data not yet available
No reference posted for this study.