Trials / Unknown
UnknownNCT04823091
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
- Sex
- All
- Age
- 14 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Chimeric antigen receptor-T cells (CAR-T) have made breakthroughs in the treatment of B-cell tumors, especially refractory/relapsed acute B lymphocytes. CD7 is a transmembrane glycoprotein expressed by T cells and natural killer cells and their precursors; it is also expressed in \>95% of lymphoblastic T-cell leukemias and lymphomas . CD7 was previously evaluated as a target for immunotoxin-loaded antibodies in patients with T-cell malignancies, but tumor responses were limited. Enhancing the potency of CD7-directed cytotoxicity by substituting donor-derived CAR-T cells for a monoclonal antibody would augment the efficacy of CD7-targeted therapy in patients with T-cell malignancies. To prepare CAR7-T cells, CD7 expression is suppressed on donor-derived T cells by unique blocking technique, and CD7-negative T cells are transduced with a humanized anti-CD7-41BB-CD3ζ lentiviral vector. This is an investigational study. The objectives are to evaluate the safety and efficacy of CAR7-T cells in patients with CD7+ T-cell malignancies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fludarabine + Cyclophosphamide + CAR7-T Cells | fludarabine 30 mg/kg on day -5, -4, and -3; cyclophosphamide 250 mg/kg on day -5, -4, and -3; CAR7-T Cells on day 0. |
Timeline
- Start date
- 2021-04-15
- Primary completion
- 2023-04-07
- Completion
- 2024-04-07
- First posted
- 2021-03-30
- Last updated
- 2022-03-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04823091. Inclusion in this directory is not an endorsement.