CT-RD06 / Nanjing Bioheng Biotech - LARVOL DELTA

Phase I Study of Allogeneic Anti-CD19 CAR-T Therapy for Patients with CD19+ Relapsed/Refractory Acute B-Lymphoblastic Leukemia (ASH 2024) - P1 | "All patients received a lymphodepletion regimen consisting of fludarabine (30mg/m2/day) and cyclophosphamide (500mg/m2/day) for three consecutive days (day -5 to day -3) before CAR-T infusion. CAR-T expansion was not detected in the DL1 patient by qPCR, potentially due to the lower dosage, while all DL2 patients showed sustained expansion from Day 4, peaking between Day 7 and Day 10, with the longest persistence exceeding 6 weeks.CONCLUSIONThe allogeneic anti-CD19 CAR-T product RD06-03 exhibited a manageable safety profile and antileukemic effects in heavily pretreated R/R B-ALL patients. Further studies with an expanded population and extended follow-up periods are warranted to validate these preliminary findings."

Clinical • P1 data • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • CD19

A phase I study of allogeneic anti-CD19 CAR-T therapy for patients with CD19+ relapsed/refractory acute B-lymphoblastic leukemia. (ASCO 2025) - P1 | "All patients received lymphodepletion with fludarabine (30mg/m^2/day) and cyclophosphamide (500mg/m^2/day) for 3 days before CAR-T infusion. The phase I trial of RD06-03 confirms its safety and efficacy in patients with R/R B-ALL. Notably, RD06-03's engineered TCR/Gene-X and NK inhibitory molecules enhance its resistance to rejection and antileukemic activity without GvHD. RD06-03 demonstrates robust persistence, achieving a 100% CR/CRi rate in medium- to high-dose groups, which is even lower than that of autologous CAR-T, while maintaining a manageable safety profile under standard lymphodepletion."

Clinical • IO biomarker • P1 data • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • CD19

The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: Anhui Provincial Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Leukemia • Lymphoma • Oncology

A Study of CT-RD06 Cell Injection in Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancy (clinicaltrials.gov) - P1; N=72; Recruiting; Sponsor: He Huang

Clinical • New P1 trial