Clinical trial · Interventional
Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances
NCT04934774CI-TRIAL-00052391unknownPhase 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 non-gene edited anti-CD7 CAR (also called anti-CD7 CAR) T cells in patients with relapsed and/or refractory T cell lymphoma or leukemia
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-cell 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 |
|---|---|---|---|
| CD7 CAR T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-CD7 CAR T cells
- description
- anti-CD7 CAR T cells Dose escalation phase: anti-CD7 CAR T cells transduced with a lentiviral vector to express CD7 chimeric receptor domain on T cells with an escalation approach, 1 e6 to 5 e6 CAR-T cells/kg.
- interventionNames
- Biological: CD7 CAR T cells
Primary outcomes (3)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- The first 28 days after infusion
- description
- Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- measure
- Type of dose-limiting toxicity (DLT)
- timeFrame
- The first 28 days after infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 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.