— Poster presentation selected for the poster discussion session (Abstract No.: PA-200): in a first-in-human study in 9 heavily pretreated, high-risk patients with relapsed/refractory multiple myeloma or plasma cell leukemia, RD140, a fully human BCMA/GPRC5D dual-targeted FasT CAR-T, achieved an objective response rate (ORR) of 88.9% (100% in the higher-dose cohort) and a minimal residual disease (MRD) negativity rate of 88.9%
— No neurotoxicity, including ICANS, was observed, and cytokine release syndrome was predominantly low-grade; built on the FasT CAR-T rapid manufacturing platform, RD140 completes cell manufacturing in just 3–4 days
SHANGHAI and NANJING, China and PLEASANTON, Calif., Sept. 25, 2026 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic malignancies and autoimmune diseases, announced preliminary data from the first-in-human (FIH) Phase 1 clinical study of RD140 — its self-developed, fully human BCMA/GPRC5D dual-targeted CAR-T product based on the FasT CAR-T rapid manufacturing platform — at the 2026 International Myeloma Society (IMS) Annual Meeting. The study is an investigator-initiated trial (IIT) in patients with relapsed/refractory multiple myeloma (R/R MM) and plasma cell leukemia (PCL), designed to evaluate the safety, tolerability, and preliminary efficacy of RD140.
The results were presented as a poster by the team of Professor Jin Lu of Peking University People's Hospital and were selected for the poster discussion session[1](Abstract No.: PA-200). The study is a first-in-human Phase 1 clinical trial (NCT06655519), and 9 patients have been enrolled and received RD140 infusion to date. The study enrolled patients with relapsed/refractory multiple myeloma who had received at least three prior lines of therapy, as well as patients with plasma cell leukemia whose disease had progressed after first-line therapy; patients with extramedullary disease or prior BCMA-targeted therapy were also eligible for enrollment. Preliminary data showed that RD140 induced deep responses in a heavily pretreated, high-risk patient population: the overall objective response rate (ORR) reached 88.9%, the MRD negativity rate reached 88.9%, and no neurotoxicity events, including immune effector cell-associated neurotoxicity syndrome (ICANS), were observed.
Study Design and Patient Baseline
After lymphodepletion conditioning with cyclophosphamide and fludarabine for three consecutive days, patients received a single RD140 infusion; two dose levels have been evaluated to date: 1×10⁵ cells/kg (DL1, n=3) and 3×10⁵ cells/kg (DL2, n=6). Among the 9 infused patients (44.4% male; median age 65 years, range 54–72 years), 8 had R/R MM and 1 had plasma cell leukemia; 6 patients had high-risk cytogenetic abnormalities (per mSMART 3.0 criteria), of whom 3 concurrently carried two high-risk cytogenetic abnormalities; 2 patients had extramedullary disease; 2 patients had previously received BCMA-targeted therapy; all 9 patients were triple-class exposed, of whom 6 were penta-exposed.
Deep Responses and an Exceptionally High MRD Negativity Rate
As of the data cutoff on May 6, 2026, with a median follow-up of 6.05 months (range 3.0–11.5), the overall objective response rate (ORR) was 88.9%, with the ORR in the higher-dose cohort (DL2) reaching 100%; 88.9% of patients achieved MRD negativity (at 10⁻⁵ ), 6 patients achieved MRD negativity as early as day 28, and median progression-free survival (mPFS) has not been reached.
Manageable Safety, with No Neurotoxicity Observed
Regarding safety, cytokine release syndrome (CRS) occurred in the 9 evaluable patients and was predominantly low-grade: 8 patients had grade 1–2 CRS and 1 patient had grade 3 CRS. The median time to CRS onset was 4 days (range 2–8), and the median duration was 5.3 days (range 4–13); no neurotoxicity (including ICANS) was observed.
Pharmacokinetics Showing a Typical Expansion Profile
Pharmacokinetic analysis showed that RD140 exhibited a typical expansion profile in peripheral blood: the median time to peak expansion was day 15 (range 8–22); the median peak CAR transgene copy number was 112,981.7 copies/μg DNA; soluble BCMA (sBCMA) levels declined below the limit of detection in all 9 patients after infusion.
Conclusion
Preliminary first-in-human data for RD140 show that this fully human BCMA/GPRC5D dual-targeted product, based on the FasT CAR-T manufacturing platform, delivers deep responses and an exceptionally high MRD negativity rate in heavily pretreated, high-risk patients with R/R MM and PCL, with a manageable safety profile — supporting further clinical evaluation with expanded sample sizes and extended follow-up.
Professor Jin Lu
Peking University People's Hospital
"We are very pleased to present preliminary data from the first-in-human study of RD140 at this year's IMS Annual Meeting. In patients with relapsed/refractory multiple myeloma (R/R MM) and plasma cell leukemia (PCL) — all triple-class exposed, mostly penta-exposed, and high-risk — RD140, leveraging its BCMA/GPRC5D dual-target design, achieved an objective response rate (ORR) of 88.9% and an exceptionally high MRD negativity rate, with no immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade observed. 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."
Reference：
Lu J, Liu Y, Dou X, et al. First-in-Human Phase 1 Study of RD140, a Fully Human BCMA/GPRC5D Dual-Targeting FasT CAR-T, in Relapsed/Refractory Multiple Myeloma (RRMM) and Plasma Cell Leukemia (PCL). 2026 IMS. Poster PA-200.
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