TCX-102 / BlueSphere Bio - LARVOL DELTA

Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: BlueSphere Bio, Inc | Trial primary completion date: Aug 2027 ➔ Sep 2026 | N=19 ➔ 0 | Trial completion date: Sep 2027 ➔ Sep 2026 | Active, not recruiting ➔ Withdrawn

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • NPM1

Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: BlueSphere Bio, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • NPM1

BSB-2002 After Cyclophosphamide and Fludarabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation (clinicaltrials.gov) - P1 | N=19 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • NPM1

Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation (clinicaltrials.gov) - P1 | N=19 | Recruiting | Sponsor: BlueSphere Bio, Inc

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • NPM1

BlueSphere Bio Announces IND Clearance of its First in Human Candidate and New Cell Therapy Portfolio for High-Risk Leukemia Patients (GlobeNewswire) - "...BlueSphere also announced three additional blood-restricted miHA TCR product candidates that are ready for clinical development - all discovered utilizing the TCXpress platform. Together, these four TCR T-cell therapy candidates comprising the TCX-101 program positions the Company’s miHA portfolio with best-in-class HLA coverage in these hematologic indications....To further expand the reach of our TCR-based portfolio, BlueSphere has broadened its pipeline to address an additional subset of AML patients having mutated NPM1. Utilizing TCXpress, the Company identified and subsequently nominated a single lead TCR reactive against mutant NPM-1 for the TCX-102 program....IND enabling work is underway with an IND filing anticipated in 2Q2025."

IND • New molecule • Acute Myelogenous Leukemia