KD-496 / KAEDI - LARVOL DELTA

Phase I clinical trial evaluating dual-targeting CAR-T cells (KD-496) against CLDN18.2 and NKG2DL in advanced gastrointestinal cancers and pancreatic cancers. (ASCO 2026) - P1 | "Following lymphodepletion with fludarabine, cyclophosphamide, and nab-paclitaxel, subjects received a single KD-496 infusion at three dose levels: 1×10⁸ (DL1), 3×10⁸ (DL2), or 5×10⁸ (DL3) CAR-T cells. These initial data demonstrate a favorable safety profile for KD-496 CAR-T cells targeting NKG2DL/CLDN18.2. The preliminary efficacy signals warrant further investigation of KD-496, particularly in gastric cancer and pancreatic cancer. (NCT06134960)."

CAR T-Cell Therapy • Clinical • Metastases • P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • NKG2D

KD-496-01: NKG2D/CLDN18.21 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumor (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Peking University | Trial completion date: Nov 2026 ➔ Nov 2027 | Trial primary completion date: Jun 2026 ➔ Jun 2027 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Trial primary completion date • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

A phase I trial of KD-496, a CLDN18.2/NKG2D dual targeting CAR-T, in patients with gastrointestinal cancers (ESMO 2025) - P1 | "Following lymphodepletion (fludarabine 25 mg/m 2 d1-2 + cyclophosphamide 250 mg/m 2 d1-3, nab-paclitaxel 100 mg day2), patients received KD-496 infusion at escalating doses: 1×10 8 (DL1), 3×10 8 (DL2), or 5×10 8 (DL3) CAR + cells. Conclusions These initial data demonstrate a favorable safety profile and promising antitumor activity for KD-496 CAR-T cells, warrants further evaluation in larger cohorts. These findings support KD-496 as a strategic approach for NKG2DL/CLDN18.2 positive gastric and pancreatic cancers."

Clinical • P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • NKG2D

Patients with advanced gastric cancer have been treated with the world's first dual-targeted KD-496 CAR-T cell and have been consistently confirmed to respond [Google translation] (bydrug.pharmcube.com) - P1 | N=12 | NCT06134960 | "In the clinical study of KD-496 CAR-T cells conducted by the Department of Gastroenterology of Peking University Cancer Hospital, two gastric cancer patients have received low-dose KD-496 CAR-T cell infusions so far, and the patients have well tolerated them and have no obvious gastrointestinal reactions, which may be due to the dual-target design of the product...a second tumor assessment was performed 8 weeks after treatment, the tumor continued to shrink, and the patient achieved a sustained confirmed response (PR) 3 months after treatment, and the second patient also achieved a reduced SD 4 weeks after treatment."

P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

NKG2D/CLDN18.21 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumor (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Peking University

Metastases • New P1 trial • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

NKG2D/CLDN18.2 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumors (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: jianming xu

New P1 trial • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18