Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EAGD T-cell infusion · 1 trial · 4 indications
The dose escalation strategy will follow the Food and Drug Administration Guideline for design of early phase clinical trials of cellular therapy products.
Safety of the infusion will be based on the risk of treatment-related severe adverse events as identified in the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Monitoring for GVHD is assessed with Grade II-IV adverse events as identified by the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) version 4.
| Arm | Type | Description |
|---|---|---|
| EAGD T-cell infusion (Phase I) | EXPERIMENTAL | Peripheral blood is collected by leukapheresis from the donor, expanded and activated on CliniMACS-Prodigy, further depleted of alpha beta T-cells using the CliniMACS Alpha Beta T-Cell Depletion System, which leaves a gamma delta T-cell rich product. This product is then infused into the recipient at either 1, 3, or 10 x 1,000,000 cells/kg concentrations depending upon the cohort. |
| EAGD T-cell infusion (Expansion) | EXPERIMENTAL | Peripheral blood is collected by leukapheresis from the donor, expanded and activated on CliniMACS-Prodigy, further depleted of alpha beta T-cells using the CliniMACS Alpha Beta T-Cell Depletion System, which leaves a gamma delta T-cell rich product. This product is then infused into the recipient at the maximum tolerated dose as determined from Phase I. |
| Name | Type | Description |
|---|---|---|
| EAGD T-cell infusion (Phase I) | DRUG | The Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product. |
| EAGD T-cell infusion (Expansion) | DRUG | The Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product. |
Inclusion Criteria: The following criteria are used to enroll patients in the study before transplant. * Patients with neoplastic hematological disorders with indication of allogeneic transplant according to the National Comprehensive Cancer Network (NCCN) or other standard guidelines as follows: ...
EAGD T-cell infusion is an investigational cell therapy being studied in Acute Myeloid Leukemia (AML). It is being evaluated in a Phase 1 clinical trial as an expanded and activated gamma delta T-cell infusion following hematopoietic stem cell transplantation and post-transplant cyclophosphamide. The trial also includes patients with Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia, and Myelodysplastic Syndromes.
EAGD T-cell infusion is being developed by IN8bio, Inc., a biopharmaceutical company. IN8bio's stock is traded under the ticker symbol INAB. The company is conducting a Phase 1 clinical trial of this investigational therapy in patients with Acute Myeloid Leukemia and other hematologic malignancies.
EAGD T-cell infusion is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants in the United States to evaluate the safety and feasibility of the treatment approach.
EAGD T-cell infusion is being studied in one active Phase 1 clinical trial registered as NCT03533816. The trial is titled 'Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide' and is recruiting 38 adult patients in the United States.
EAGD T-cell infusion refers to expanded and activated gamma delta T-cells, a type of cell therapy. The clinical trial NCT03533816 evaluates this specific approach, which involves infusing these cells after hematopoietic stem cell transplantation. The therapy is being developed by IN8bio, Inc. for hematologic malignancies including Acute Myeloid Leukemia.