Haplo / Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted ?? T Cells for Relapsed or Refractory Solid Tumour
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colorectal Cancer
- Gastric Cancer
- Nasopharyngeal Carcinoma
- Prostate Cancer
- Sarcoma
- Triple -Negative Breast Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Intervention Model: Sequential AssignmentIntervention Model Description: The study consisT of "3 + 3" dose escalation study design with 3 distinct dose level. The first dose level will be at 3 x 10^8 chimeric antigen receptor (CAR) grafted ?? T cells per infusion. The second dose level will be at 1 x 10^9 CAR-??T cells per infusion. The third dose level will be increased to 3 x 10^9 cells CAR-??T cells. Each cycle of therapy will consist of 4 intravenous infusions, given 7 days apart.Masking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
CTM-N2D-101 is a phase I dose-escalation study to evaluate the safety of CTM-N2D and the feasibility to produce CTM-N2D for three target dose levels between 3x10^8 - 3x10^9 per infusion will be tested. Four doses will be given at an interval of a week into subjects with relapsed or refractory solid ...
CTM-N2D-101 is a phase I dose-escalation study to evaluate the safety of CTM-N2D and the feasibility to produce CTM-N2D for three target dose levels between 3x10^8 - 3x10^9 per infusion will be tested. Four doses will be given at an interval of a week into subjects with relapsed or refractory solid tumors. A typical 3+3 design will be used to determine the safe regimen basing on the incidence of dose-limiting toxicity (DLT). The identified safe regimen will be used for further phase II studies for selected indications.
Tracking Information
- NCT #
- NCT04107142
- Collaborators
- Not Provided
- Investigators
- Not Provided
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