NCT05270928

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 27, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2023

Completed
Last Updated

July 27, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

February 27, 2022

Last Update Submit

July 25, 2023

Conditions

Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

  • Dose limiting toxicity (DLT)

    21 days post IBI346 administration

  • Incidence and severity of adverse events: Proportion of subjects with treatment-related adverse events assessed by NCI-CTCAE v5.0 criteria

    2 years post IBI346 administration

  • Presence or absence of replication-competent lentivirus (RCL)

    Baseline up to 15 years

Secondary Outcomes (13)

  • Objective Response Rate (ORR)

    3 months post IBI346 administration

  • Duration of Response (DOR)

    2 years post IBI346 administration

  • Progression-free Survival (PFS)

    2 years post IBI346 administration

  • Overall Survival (OS)

    2 years post IBI346 administration

  • Pharmacokinetics parameters of IBI346 cells -Maximum CAR level in blood (Cmax)

    2 years post IBI346 administration

  • +8 more secondary outcomes

Study Arms (1)

IBI346

EXPERIMENTAL

Single arm

Drug: IBI346

Interventions

IBI346DRUG

IBI346 Antibody and IBI346 CAR-T cell injection

IBI346

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
  • Subjects must have previously received at least 3 anti-myeloma regimens. Subjects must have documented disease progression (according to IMWG criteria) during or within 12 months of completing their last anti-myeloma regimen prior to study entry; and prior regimens must have included proteasome inhibitor (PI) and immunomodulatory drug (IMiD).
  • Measurable disease as defined by the protocol
  • ECOG score is 0 or 1.
  • Expected survival time ≥12 weeks.

You may not qualify if:

  • Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants drugs.
  • Patients who received autologous hematopoietic stem cell transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection.
  • No unmobilized mononuclear cells can be collected for CAR T cell production.
  • Screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses \< 10mg/ day).
  • Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2022

First Posted

March 8, 2022

Study Start

April 27, 2022

Primary Completion

December 21, 2022

Study Completion

May 29, 2023

Last Updated

July 27, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)