Clinical trial · Interventional
Anti-CD7 CAR-Engineered T Cells for T Lymphoid Malignancies Malignancies
Safety and Efficacy of Anti-CD7 CAR-Engineered T Cells for Relapsed/Refractory T Lymphoid Malignancies: a Single-center, Open-label, Non-randomized, Single-arm Clinical Study
NCT04823091CI-TRIAL-00057164unknownPhase 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 single-center, open-label, single-arm study to evaluate the primary safety and efficacy of anti-CD7 chimeric antigen receptor(CAR)-modified T cells(CAR7-Ts) in patients with relapsed or refractory T lymphoid malignancies.
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 Chronic Lymphocytic Leukemia | — | UNRESOLVED | — |
| T-Cell Lymphocytic Leukemia | — | UNRESOLVED | — |
| T Cell Non-Hodgkin Lymphoma | T-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine + Cyclophosphamide + CAR7-T Cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fludarabine + Cyclophosphamide + anti-CD7 CAR-T Cells
- description
- Patients will received lymphodepletion with fludarabine (30 mg/kg) and cyclophosphamide (250 mg/kg) on day -5, -4, and -3, followed by the infusion of CAR7-T cells with the dose of 1×10\^6/kg and 2×10\^6/kg (with an allowance of ±20%). If no dose-limited toxicity (DLT) emerges in the group, then the subsequent higher dose will be used in the next group. If DLT emerges in a single subject in any dose level, 3 more subjects will be enrolled to the same dose level. The maximum dose could be extended.
- interventionNames
- Drug: Fludarabine + Cyclophosphamide + CAR7-T Cells
Primary outcomes (1)
- measure
- Incidence of Treatment-related Adverse Events
- timeFrame
- within 2 years after infusion
- description
- Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged from 14 to 70 years; 2. Expected survival over 60 days; 3. Eastern Cooperative Oncology Group score 0-2; 4. Diagnosed as T-cell hematologic malignancies (including leukemia and lymphoma) according to WHO2016 criteria; 5. Patients must relapse or be refractory after at least two lines of therapy. 6. CD7 were positive in bone marrow or cerebrospinal fluid by immunohistochemistry or flow cytometry at screening, and one of the following conditions is satisfied: A. No remission was achieved after at least 2 lines of standard therapy; B. Relapse or progression after standard treatment; C. Relapse after autologous or allogeneic hematopoietic stem cell transplantation; 7. Have no fertility requirements or plans for one year since enrollment in this clinical trial; 8. Patient or his or her legal guardian voluntarily participates in and signs an informed consent form. Exclusion Criteria: 1. Complicated with central system leukemia/lymphoma with active intracranial lesions; 2. Existing or preexisting CNS conditions, such as epileptic seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS related autoimmune disease; 3. Symptomatic heart failure or severe arrhythmias; 4. Symptoms of severe respiratory failure; 5. Complicated with other types of malignant tumors; 6. Serum creatinine and/or urea nitrogen ≥ 1.5 times of normal value; 7. Suffer from sepsis or other uncontrollable infections; 8. Intracranial hypertension or brain consciousness disorder; 9. Severe mental disorders; 10. Have received organ transplantation (excluding bone marrow transplantation); 11. Female patients (fertile patients) had positive blood HCG test; 12. Hepatitis (including hepatitis B and C), AIDS and syphilis were screened positive; 13. Patients with graft-versus-host disease (GVHD) or who require immunosuppressant treatment; 14. The absolute value of lymphocytes was too low to manufacture CART cells; 15. Other conditions considered inappropriate by the researcher.
References
Publications (1)
- BACKGROUNDGomes-Silva D, Srinivasan M, Sharma S, Lee CM, Wagner DL, Davis TH, Rouce RH, Bao G, Brenner MK, Mamonkin M. CD7-edited T cells expressing a CD7-specific CAR for the therapy of T-cell malignancies. Blood. 2017 Jul 20;130(3):285-296. doi: 10.1182/blood-2017-01-761320. Epub 2017 May 24. PMID 28539325