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NOT YET RECRUITING
NCT05181501
PHASE1

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

Sponsor: Nanjing IASO Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-04

Completion Date

2039-04

Last Updated

2022-01-06

Healthy Volunteers

No

Interventions

DRUG

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

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.

Locations (4)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China