RD118 / IASO BIO - LARVOL DELTA

Blood Publishes Promising Results of IASO Bio's Anti-GPRC5D CAR-T RD118 in Relapsed/Refractory Multiple Myeloma (PRNewswire) - "A total of eighteen patients received RD118 infusion in this study, including 17 with R/R MM and 1 with a history of primary plasma cell leukemia....The overall response rate (ORR) was 94.4%, with 72.2% of patients achieving complete response or stringent complete responses (CR/sCR). Among the seven patients who had received prior BCMA-directed CAR T-cell therapy, the ORR was 85.7%, with 5 patients (71.4%) achieving CR/sCR....The median progression-free survival (PFS) was 18.2 months, with 12-month PFS and overall survival (OS) rates of 82.1% and 93.3%, respectively."

P1 data • Multiple Myeloma • Plasma Cell Leukemia

Fully Human anti-GPRC5D CAR T-Cell Therapy RD118 Induces Durable Remissions in Relapsed/Refractory Multiple Myeloma. (PubMed, Blood) - P1 | "These findings support that RD118 is a highly effective and safe therapeutic option for heavily pretreated RRMM. This trial is registered at ClinicalTrials.gov as NCT05759793 and NCT05219721."

Journal • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia

CAR-GPRC5DCI001: A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Chunrui Li | Trial completion date: Mar 2024 ➔ Oct 2025 | Trial primary completion date: Dec 2022 ➔ Sep 2025

Trial completion date • Trial primary completion date • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia • GPRC5D

RD138CI002: A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Nanjing IASO Biotechnology Co., Ltd. | Trial completion date: Mar 2025 ➔ Oct 2026 | Trial primary completion date: Mar 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia • GPRC5D

Comprehensively Covering Multiple Myeloma: IASO Bio's GPRC5D CAR-T Product RD118 Receives IND Approval from NMPA (PRNewswire) - P1 | N=18 | NCT05219721 | P1 | N=12 | NCT05759793 | Sponsor: Nanjing IASO Biotechnology Co., Ltd. | "An investigator-initiated clinical trial (IIT) (ClinicalTrials.gov identifier: NCT05759793, NCT05219721) is being conducted to preliminary investigate the safety and efficacy of RD118 injection in patients with RRMM or plasma cell leukemia....The trial enrolled patients with multiple myeloma or plasma cell leukemia who have previously received at least three lines of therapy (must include at least one proteasome inhibitor and one immunomodulator). Patients who have previously received BCMA CAR-T therapy can also be enrolled. The trial investigated RD118 at the doses of 1.0–3.0 × 10⁶ CAR-T cells/kg. As of Nov. 20, 2023, the dose-escalation phase has completed subject enrollment and infusion. The subjects who received infusion have demonstrated good safety and efficacy profiles. Patients with prior BCMA CAR-T therapy have also shown benefits."

Enrollment status • P1 data • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology

Comprehensively Covering Multiple Myeloma: IASO Bio's GPRC5D CAR-T Product RD118 Receives IND Approval from NMPA (PRNewswire) - "IASO Biotechnology...today announces that the investigational new drug (IND) application for RD118, an independently developed, fully human GPRC5D-targeting chimeric antigen receptor T-cell (CAR-T) therapy, has been approved by the National Medical Products Administration (NMPA) for treatment of relapsed/refractory multiple myeloma (RRMM)."

New trial • Hematological Malignancies • Multiple Myeloma • Oncology

A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Nanjing IASO Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • GPRC5D • IL6

Immunotherapy, CAR T-Cell Therapy for Multiple Myeloma Patients a Discussion (Oncology Tube) - "Philip McCarthy, MD...provided an overview of CAR T-cell therapy, focusing on its application in multiple myeloma. CAR T-cell therapy involves genetically modifying T-cells to express a chimeric antigen receptor (CAR) that recognizes a specific antigen on tumor cells, such as BCMA (B-cell maturation antigen)....Ongoing research aims to improve the therapy's efficacy and broaden its applicability beyond BCMA."

Video

A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Nanjing IASO Biotherapeutics Co.,Ltd

CAR T-Cell Therapy • New P1 trial • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • GPRC5D • IL6

Multiple Myeloma Therapies: A Glimpse Into the Future (Medscape) - "Joseph Mikhael, MD...Today, we're talking about future therapies in multiple myeloma....Shah: You've brought up some really good points. Bispecifics are poised to change the way we approach myeloma patients in some regard. For background information, bispecific T-cell engagers are just that; they're a molecule that's off the shelf....so we can ride that wave and yet not have to send the patient to receive apheresis."

Audio

A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Chunrui Li | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2023 ➔ Mar 2024

CAR T-Cell Therapy • Enrollment open • Trial completion date • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • GPRC5D • IL6