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CompletedNCT05270928Updated Jul 27, 2023

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

A Phase 1 interventional study of IBI346 in Relapsed/Refractory Multiple Myeloma, sponsored by The First Affiliated Hospital of Soochow University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by The First Affiliated Hospital of Soochow University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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

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Conditions studied

  • Relapsed/Refractory Multiple Myeloma

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In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 6 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
  2. 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).
  3. Measurable disease as defined by the protocol
  4. ECOG score is 0 or 1.
  5. Expected survival time ≥12 weeks.

Exclusion criteria

Exclusion Criteria:

  1. Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants drugs.
  2. 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.
  3. No unmobilized mononuclear cells can be collected for CAR T cell production.
  4. 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).
  5. Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg).
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    IBI346

    Single arm

    Drug: IBI346

Interventions

  • DrugIBI346

    IBI346 Antibody and IBI346 CAR-T cell injection

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What researchers measure

Primary outcomes

  1. Dose limiting toxicity (DLT)

    Time frame: 21 days post IBI346 administration

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

    Time frame: 2 years post IBI346 administration

  3. Presence or absence of replication-competent lentivirus (RCL)

    Time frame: Baseline up to 15 years

Secondary outcomes

  1. Objective Response Rate (ORR)

    Number of patients with a best response of either complete response, stringent complete response, very good partial response or partial response, assessed using modified International Myeloma Working Group response criteria（2016）

    Time frame: 3 months post IBI346 administration

  2. Duration of Response (DOR)

    DOR will be calculated among responders (with a PR or better response) from the date of initial response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria (2016).

    Time frame: 2 years post IBI346 administration

  3. Progression-free Survival (PFS)

    PFS defined as time from date of initial administration of IBI346 to date of first disease progression according to IMWG criteria (2016), or death due to any cause, whichever occurs first.

    Time frame: 2 years post IBI346 administration

  4. Overall Survival (OS)

    OS is measured from the date of the initial administration of IBI346 to the date of the subject's death.

    Time frame: 2 years post IBI346 administration

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

    Time frame: 2 years post IBI346 administration

  6. Pharmacokinetics parameters of IBI346 cells -Time to peak CAR level in blood (Tmax)

    Time frame: 2 years post IBI346 administration

  7. Pharmacokinetics parameters of IBI346 cells - Area under the curve of the CAR level in blood (AUC)

    Time frame: 2 years post IBI346 administration

  8. Pharmacokinetics parameters of IBI346 antibody- Peak Plasma Concentration (Cmax)

    Time frame: 2 years post IBI346 administration

  9. Pharmacokinetics parameters of IBI346 antibody- Area under the plasma concentration versus time curve (AUC)

    Time frame: 2 years post IBI346 administration

  10. Pharmacokinetics parameters of IBI346 antibody- clearance (CL)

    Time frame: 2 years post IBI346 administration

  11. Pharmacokinetics parameters of IBI346 antibody- half-life (t1/2)

    Time frame: 2 years post IBI346 administration

  12. Positive rate of human anti-P329G CAR antibody

    Time frame: 2 years post IBI346 administration

  13. Positive rate of anti-drug antibody (ADA) of P329G BCMA antibody

    Time frame: 2 years post IBI346 administration

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Study locations

1 site
  • The First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215000, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05270928
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Mar 8, 2022
Start date
Apr 27, 2022
Primary completion
Dec 21, 2022
Completion
May 29, 2023
Last update
Jul 27, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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