IASO Bio's Dual-Targeted FasT CAR-T RD140 Yields 88.9% ORR in First-in-Human Myeloma Study
核心洞察
IASO Bio reported first-in-human Phase 1 data for RD140, a fully human BCMA (搜索)/GPRC5D (搜索) dual-targeted FasT CAR-T, in 9 heavily pretreated patients with relapsed/refractory multiple myeloma (搜索) or plasma cell leukemia (搜索).
The overall objective response rate was 88.9% and reached 100% in the higher-dose cohort, with an MRD negativity rate of 88.9% at 10-5 sensitivity.
No neurotoxicity, including ICANS, was observed; cytokine release syndrome occurred in all 9 patients but was predominantly grade 1 to 2, with one grade 3 case.
IASO Biotechnology (搜索) reported preliminary first-in-human Phase 1 results for RD140, its fully human BCMA (搜索)/GPRC5D (搜索) dual-targeted CAR-T built on the FasT CAR-T rapid manufacturing platform, in patients with relapsed/refractory multiple myeloma (搜索) (R/R MM) and plasma cell leukemia (搜索) (PCL). The data were presented as a poster at the 2026 International Myeloma Society (IMS) Annual Meeting by the team of Professor Jin Lu of Peking University People's Hospital and were selected for the poster discussion session (Abstract No. PA-200).
The investigator-initiated trial (NCT06655519) is designed to evaluate the safety, tolerability and preliminary efficacy of RD140. Nine patients have been enrolled and infused to date. Enrollment covered patients with R/R MM who had received at least three prior lines of therapy, and patients with plasma cell leukemia (搜索) whose disease had progressed after first-line therapy. Patients with extramedullary disease or prior BCMA (搜索)-targeted therapy were also eligible.
Study Design and Patient Baseline
Patients received lymphodepletion conditioning with cyclophosphamide and fludarabine for three consecutive days, followed by a single RD140 infusion. Two dose levels have been evaluated: 1x10^5 cells/kg (DL1, n=3) and 3x10^5 cells/kg (DL2, n=6).
Among the 9 infused patients, 44.4% were male, with a median age of 65 years (range 54 to 72). Eight patients had R/R MM and one had plasma cell leukemia (搜索). Six patients carried high-risk cytogenetic abnormalities per mSMART 3.0 criteria, and three of those concurrently carried two high-risk cytogenetic abnormalities. Two patients had extramedullary disease and two had previously received BCMA (搜索)-targeted therapy. All nine patients were triple-class exposed, and six were penta-exposed.
Deep Responses and MRD Negativity
As of the data cutoff on May 6, 2026, with a median follow-up of 6.05 months (range 3.0 to 11.5), the overall objective response rate (ORR) was 88.9%, rising to 100% in the higher-dose DL2 cohort. MRD negativity at 10^-5 was achieved in 88.9% of patients, with six patients reaching MRD negativity as early as day 28. Median progression-free survival had not been reached.
Safety Profile
Cytokine release syndrome (CRS) occurred in all nine evaluable patients and was predominantly low-grade: eight patients had grade 1 to 2 CRS and one had grade 3 CRS. Median time to CRS onset was 4 days (range 2 to 8) and median duration was 5.3 days (range 4 to 13). No neurotoxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), was observed.
Pharmacokinetics
RD140 showed a typical expansion profile in peripheral blood. Median time to peak expansion was day 15 (range 8 to 22), and median peak CAR transgene copy number was 112,981.7 copies/µg DNA. Soluble BCMA (搜索) (sBCMA) levels declined below the limit of detection in all nine patients after infusion.
Manufacturing and Next Steps
The FasT CAR-T platform completes cell manufacturing in 3 to 4 days. "Of particular note, the FasT CAR-T rapid manufacturing platform enables cell manufacturing to be completed in just 3-4 days, significantly shortening the waiting time for patients and securing a valuable treatment window for more critically ill patients," Professor Jin Lu said.
The investigators concluded that the preliminary first-in-human data support further clinical evaluation of RD140 with expanded sample sizes and extended follow-up.