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Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection（CT103A）will be infused at 1.0 x 10\^6 CAR+ T cells/kg in newly diagnosed subjects with high-risk multiple myeloma

CT103A is a customized, BCMA-targeted genetically modified autologous T cell immunotherapy, which can identify and eliminate malignant and normal cells expressing BCMA. CAR specifically recognizes BCMA with single chain fragment variable (ScFv), and promotes the activation, proliferation, cytokine secretion and target cell killing of CAR-T through the CD3ζ domain. And 4-1BB enhances the expansion and persistence of CT103A.

CT103A will be infused at 1.0×10\^6 /kg via intravenous drip within 24h to 72h after chemotherapy conditioning regimen at the recommended infusion rate of 3-5 mL/min.

Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)

Lijuan Chen, M.D.

Kaiyang Ding, M.D.

Weiying Gu, M.D.

Bing Chen, M.D.

This study is a multi-center, single-arm clinical study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamic characteristics of CT103A as the first-line treatment in newly diagnosed high-risk multiple myeloma subjects with induction chemotherapy as bridging therapy.

Before enrollment, subjects will receive chemotherapy regimen of either Bortezomib-Lenalidomide-Dexamethasone (VRD), Bortezomib-Cyclophosphamide-Dexamethasone (PCD) or Bortezomib-Adriamycin-Dexamethasone (PAD) as induction therapy for 3 cycles. Evaluation will be made after 2 cycles of chemotherapy. If the subject is not intended to have stem cell transplantation or unsuitable for autologous hematopoietic stem cell transplantation (ASCT) as judged by the investigator, he/she will receive the 3rd cycle of chemotherapy. If the subject meets the inclusion criteria, he/she will be enrolled in the study.

Peripheral blood mononuclear cell (PBMC) will be collected to manufacture CT103A. After PBMC collection, the subject will receive another cycle of chemotherapy and evaluated. Lymphodepletion with fludarabine and cyclophosphamide will be performed for three consecutive days. After 1-day rest, subjects will receive a single infusion of CT103A at 1.0 ×10\^6 /kg. Subjects will be followed in the study for a minimum of 2 years after CT103A infusion. Long-term follow-up for lentiviral vector safety will be followed for up to 15 years after CT103A infusion.

A Study of Fully Human BCMA CAR-T (CT103A) in Patients With Newly Diagnosed High-risk Multiple Myeloma (FUMANBA-2)

A Multi-center Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T (CAR-T) Cell Injection (CT103A) in the Treatment of Newly Diagnosed Subjects With High-risk Multiple Myeloma (FUMANBA-2)

The proportion of subjects who achieve MRD-negativity after CT103A infusion.

The median time from the date of CT103A infusion to the date of first disease progression or death from any cause.

The proportion of subjects who achieve stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) after CT103A infusion.

The median time from the date of CT103A infusion to the date of death from any reason.

The time from date of CT103A infusion to the date of death from any reason, relapse, treatment failure, disease progression or initiation of other anti-tumor treatment, whichever comes first;

The time from the first assessment of sCR or CR or VGPR or PR to the first assessment of disease progression or death from any cause;

Incidence of treatment-emergent adverse events (TEAE) and Treatment-related adverse events (TRAE).

The maximum CT103A concentration and the copy number of the lentiviral vector (vector copy number, VCN) in peripheral blood (Cmax)

The time to reach the maximum concentration (Tmax)

The area under the concentration time curve from time zero to day 28 (AUC0-28d) and from time zero to day 90 (AUC0-90d)

The levels of soluble BCMA in peripheral blood at each time point.

The levels of cytokines (IL-6, serum ferritin, etc.) in peripheral blood at each time point

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Fully Human BCMA CAR-T (CT103A) in Patients With Newly Diagnosed High-risk Multiple Myeloma (FUMANBA-2)	NCT05181501	Multiple Myelom...	Fully human BCM...	18 Years - 70 Years	Nanjing IASO Biotechnology Co., Ltd.
A Study of Fully Human BCMA CAR-T (CT103A) in Patients With Newly Diagnosed High-risk Multiple Myeloma (FUMANBA-2)	NCT05181501	Multiple Myelom...	Fully human BCM...	18 Years - 70 Years	Nanjing IASO Biotechnology Co., Ltd.

Spots Global Cancer Trial Database for fully human bcma chimeric antigen receptor autologous t cell injection (ct103a)