Qihan Bio Announces Completion of FDA Pre-IND Meeting for Dual-Targeting In Vivo CAR-T Therapy for Relapsed/Refractory Multiple Myeloma

On June 17, Hangzhou Qihan Biotech Co., Ltd. announced that its developed dual-target in vivo CAR-T candidate drug had previously completed the pre-IND meeting with the U.S. FDA. Both parties reached preliminary consensus on product design, GMP manufacturing processes, quality control standards, non-clinical evaluation protocols, and Phase I clinical trial design. Based on this communication,The company expects to formally submit the Investigational New Drug (IND) application for clinical trials in the third quarter of 2026.。

Qihan Biotech’s press release stated that the dual-targeted in vivo CAR-T（In vivo CAR-T）The proposed indication for the product isRelapsed/Refractory Multiple Myeloma (RRMM). This product generates in situ within the patient’s body via a highly efficient, low off-target delivery vectorBispecific CAR-T Cells Targeting CD19 and BCMA, distinct from the ex vivo manufacturing model of traditional autologous CAR-T therapy, it can circumvent clinical pain points such as prolonged cell collection cycles, high manufacturing costs, and variable quality of patients’ autologous cells. The dual-target design aims to reduce the risk of relapse caused by tumor antigen escape. Preclinical studies and early-phase investigator-initiated clinical trials have demonstrated its favorable efficacy and safety profile.

References:
[1]Qihan Biotech’s Dual-Target In Vivo CAR-T Product Completes FDA Pre-IND Meeting; U.S. IND Submission Expected in Q3. From https://mp.weixin.qq.com/s/XcE0s2tuTyKw_Fi7Q57VAw

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