Grant Award Details

Phase 1/1b study of T-allo10 infusion after HLA-partially matched abdepleted-HSCT in children and young adults with hematologic malignancies.
Grant Number: 
CLIN2-12563
Investigator: 
Institution: 
Type: 
PI
Award Value: 
$11,996,634
Status: 
Pre-Active

Grant Application Details

Application Title: 
  • Phase 1/1b study of T-allo10 infusion after HLA-partially matched abdepleted-HSCT in children and young adults with hematologic malignancies.
Public Abstract: 

Therapeutic Candidate or Device

An immunotherapy cell product, T-allo10, that is enriched for specialized immune cells called type I regulatory T (Tr1) cells

Indication

Children and young adults with relapse/refractory acute leukemia receiving a specialized stem cell transplant, αβdepleted-HSCT

Therapeutic Mechanism

αβdepleted-HSCT has increased the number of patients who can safely receive transplants, however this strategy cannot provide a fast reconstitution of the immune system which is critical for infection fighting functions and prevention of leukemia relapse. The proposed therapy, T-allo10, when given after αβdepleted-HSCT has the potential to accelerate recovery of immune responses without graft versus host disease, thus improving cancer-free outcomes for children with leukemia.

Unmet Medical Need

Hematologic malignancies are the most common cancer in children and young adults, and current treatment options do not offer long-term cure. We propose that post-αβdepleted HSCT infusion of T-allo10 will improve the probability of being alive and disease free, thus addressing an unmet medical need.

Project Objective

Phase 1/1b to select dose, safety & pilot efficacy

Major Proposed Activities

  • Determine recommended Phase 2 dose (RP2D) of T-allo10 cell product for for high risk patients with hematologic malignancies receiving αβdepleted-HSCT
  • Evaluate the safety, and explore the potential for clinical efficacy of infusion of T-allo10 at the RP2D (or highest dose) after αβdepleted-HSCT
  • Perform immune monitoring to establish immune criteria that predict successful patient outcomes.
Statement of Benefit to California: 

Almost 500 children/year receive stem cell transplants in California. A durable cure for these children can provide a great economic benefit to the state. A successful outcome of our trial will significantly reduce the length of hospitalization, thus reducing patient care costs, as well as the risk of the need for a second transplant. Thus, the benefit to California is the improved lives of its citizens (both patients and family members) while simultaneously decreasing the societal costs.