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NCT05270928

Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y001#

Completed Phase 1 Last updated 27 July 2023
What this trial tests

Phase 1 trial testing IBI346 in Relapsed/Refractory Multiple Myeloma in 6 participants. Completed in 29 May 2023.

Timeline
27 April 2022
Primary endpoint
21 December 2022
29 May 2023

Quick facts

Lead sponsorThe First Affiliated Hospital of Soochow University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date27 April 2022
Primary completion21 December 2022
Estimated completion29 May 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

The First Affiliated Hospital of Soochow University

Who can join

18 and older, any sex, with Relapsed/Refractory Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting B Cell Maturation Antigen in Patients with Multiple Myeloma: Current Perspectives.
    Shrivastava T, Van Rhee F, Al Hadidi S. · · 2023 · cited 10× · PMID 37359353 · DOI 10.2147/ott.s370880
  2. The Current Landscape of Modular CAR T Cells.
    Joechner AH, Mach M, Li Z. · · 2025 · PMID 41465327 · DOI 10.3390/ijms262411898
  3. P329G-engager: a universal mix & match antibody-based adaptor platform for cancer immunotherapy.
    Surowka M, Darowski D, Hutter-Karakoc I, Claus C, et al · · 2026 · PMID 41402230 · DOI 10.1080/19420862.2025.2602993
  4. P1406: SAFETY AND EFFICACY OF IBI346, A FIRST-IN-CLASS BCMA-TARGETING MODULAR CAR-T CELL THERAPY, FOR PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM): PRELIMINARY RESULTS FROM TWO PHASE I STUDIES
    Fu C, LI C, Wang D, Jin S, et al · · 2023

Verify or expand the search:

Other trials of IBI346

Trials testing the same drug.

Other recruiting trials for Relapsed/Refractory Multiple Myeloma

Currently open trials in the same condition.

Other The First Affiliated Hospital of Soochow University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05270928.

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