Clinical trial · Interventional
CD7 CAR T-cell for R/R CD7+ T Cell Lymphoma
Humanized CD7 CAR T-cell Therapy for R/R CD7+ T Cell Lymphoma
NCT05059912CI-TRIAL-00054123unknownPhase 2ClinicalTrials.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 prospective, open-label, multiple center and single arm phase 2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive T cell 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 |
|---|---|---|---|
| Refractory and Relapsed T Cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Humanized CD7 CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD7 positive relapsed or refractory T cell lymphoma
- description
- Humanized CD7 CAR-T cells intravenously infused to patient with R/R T-NHL\[ at a dose of (0.5- 5)x10\^6 CD7 CAR-T cells/kg
- interventionNames
- Biological: Humanized CD7 CAR-T cells
Primary outcomes (2)
- measure
- Overall response rate (ORR)
- timeFrame
- 1 year
- description
- Number of patients who achieved response (complete response and partial response ) after treatment of CD7 CAR-T cell. Response will be assessed using the Lugano criteria.
- measure
- Number of Adverse Events
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. R/R T-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry 3. The expressions of both CD4 and CD8 are negative in patients with bone marrow involved 4. The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points 5. The main organ functions need to meet the following conditions: A.Left ventricular ejection fraction ≥50% B.Creatinine ≤132umol/l or creatinine clearance ≥60 ml/min C.ALT and AST≤2.5 upper limitation of normal D.T-BIL≤2.0mg/dl E.SpO2 \> 90% 6. Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion 7. Expected survival exceeds 3 months 8. Written informed consent could be acquired Exclusion Criteria: 1. Immunosuppressant medications or steroids were used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years 2. Patients with uncontrolled active infection 3. Active hepatitis B or hepatitis C infection 4. Patients with HIV infection 5. Severe acute or chronic graft-versus-host disease (GVHD) 6. Participated in any other drug research clinical trials within 30 days before enrollment 7. Prior CAR-T cells therapy within 3 months before enrollment 8. Prior allogeneic hematopoietic stem cell transplantation within 6 months before enrollment 9. Uncontrolled other tumor 10. Women in pregnancy, lactation or planning to become pregnant 11. The researcher considers inappropriate to participate in this research
References
Publications (0)
Data not yet available
No reference posted for this study.