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A Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (CT103A) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

NCT05698303 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-01-26

No results posted yet for this study

Summary

It is a dose expansion, open-label, phase Ib study to evaluate the safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of CT103A in patients with relapsed/refractory multiple myeloma.

Conditions

Interventions

DRUG

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

CT103A is an BCMA targeted genetically modified autologous T cell immunotherapy product that identifies and eliminates BCMA-expressing malignant and normal cells. CAR specifically recognizes BCMA with a low-immunogenic fully human single chain fragment variable (scFv), promotes CAR-T activation, proliferation, cytokine secretion and target cell killing through the CD3ζ domain, and enhances CAR-T proliferation and persistence through co-stimulatory signaling via 4-1BB.

Sponsors & Collaborators

  • Nanjing IASO Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Nanjing IASO Biotherapeutics Co.,Ltd. Clinical trial · Nanjing IASO Biotechnology Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-08
Primary Completion
2024-05-20
Completion
2026-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05698303 on ClinicalTrials.gov