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OpenTrials
Completed

NCT Number: NCT05270928

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

IBI346

Drug

IBI346 Antibody and IBI346 CAR-T cell injection

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)

    Time frame: 3 months post IBI346 administration

    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)

  2. Duration of Response (DOR)

    Time frame: 2 years post IBI346 administration

    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).

  3. Progression-free Survival (PFS)

    Time frame: 2 years post IBI346 administration

    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.

  4. Overall Survival (OS)

    Time frame: 2 years post IBI346 administration

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

  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

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

Registry information

Official study title

An Open, Single-arm Clinical Study Evaluating the Safety and Efficacy of IBI346 Infusion in Relapsed/Refractory Multiple Myelom

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 8, 2022
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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