iC9-CAR19 cells / Bellicum - LARVOL DELTA

Administration of Autologous CAR-T CD19 Antigen With Inducible Safety Switch in Patients With Relapsed/Refractory ALL (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: UNC Lineberger Comprehensive Cancer Center | Phase classification: P1/2 ➔ P1

Phase classification • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR • CD19

Administration of Autologous CAR-T CD19 Antigen With Inducible Safety Switch in Patients With Relapsed/Refractory ALL (clinicaltrials.gov) - P1/2 | N=17 | Active, not recruiting | Sponsor: UNC Lineberger Comprehensive Cancer Center | Trial completion date: Aug 2040 ➔ Sep 2037 | Trial primary completion date: Dec 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR • CD19

Administration of Autologous CAR-T CD19 Antigen With Inducible Safety Switch in Patients With Relapsed/Refractory ALL (clinicaltrials.gov) - P1/2 | N=17 | Active, not recruiting | Sponsor: UNC Lineberger Comprehensive Cancer Center | Recruiting ➔ Active, not recruiting | N=54 ➔ 17 | Trial completion date: Apr 2041 ➔ Aug 2040 | Trial primary completion date: Apr 2026 ➔ Dec 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR • CD19

Bellicum Announces Presentation by UNC at ASH 2022 on Potential Abrogation of iC9 CAR T-Cell Toxicities with Rimiducid (GlobeNewswire) - P1/2 | N=54 | NCT03016377 | "The UNC Lineberger research team reported the clinical and pharmacodynamic courses of ICANS for four patients treated with rimiducid in an ongoing cell dose expansion cohort of a Phase I/II trial of iC9 CAR.19 cells to treat B-lymphoblastic leukemia (B-ALL). According to the poster, rimiducid administration to these patients experiencing corticosteroid-unresponsive grade 3-4 ICANS was associated with abrupt reduction of circulating iC9 CAR.19 cells and lower ICANS grade within 24 hours. The UNC Lineberger research team concluded that iC9 holds promise as a tool to potentially abrogate the most severe CAR T-cell toxicities."

Adverse events • P1/2 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Administration of Autologous CAR-T CD19 Antigen With Inducible Safety Switch in Patients With Relapsed/Refractory ALL (clinicaltrials.gov) - P1/2; N=54; Recruiting; Sponsor: UNC Lineberger Comprehensive Cancer Center; Trial completion date: Oct 2036 ➔ Apr 2041; Trial primary completion date: Nov 2021 ➔ Apr 2026

CAR T-Cell Therapy • Clinical • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19

Administration of Autologous CAR-T CD19 Antigen With Inducible Safety Switch in Patients With Relapsed/Refractory ALL (clinicaltrials.gov) - P1/2; N=54; Recruiting; Sponsor: UNC Lineberger Comprehensive Cancer Center; Active, not recruiting ➔ Recruiting; Phase classification: P1 ➔ P1/2; N=40 ➔ 54

Clinical • Enrollment change • Enrollment open • Phase classification