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WithdrawnNCT05980507Updated Dec 22, 2023

An Open Label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ICI201 Infusion in Relapsed/Refractory Multiple Myeloma

A Phase 1 interventional study of ICI201 in Relapsed/Refractory Multiple Myeloma, sponsored by The First Affiliated Hospital of Soochow University. Withdrawn at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-22.

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

Why this study was withdrawn
Molecular development strategy adjustment
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

An open label, single-arm clinical study evaluating the safety and efficacy of ICI201 infusion in relapsed/refractory multiple myeloma

02

Conditions studied

  • Relapsed/Refractory Multiple Myeloma
03

In context

Multiple Myeloma

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

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. 6. GPRC5D positive expression in bone marrow plasma cells

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. 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). 4. Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg). 5. Patients who have recieved GPRC5D-targeted therapy
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Study design

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

Study arms

  • Experimental
    ICI201

    Drug: ICI201

Interventions

  • DrugICI201

    ICI201 CAR-T cell injection

06

What researchers measure

Primary outcomes

  1. Dose limiting toxicity (DLT)

    Dose limiting toxicity (DLT)

    Time frame: Time Frame: 28 days post ICI201 administration

  2. Incidence and severity of all adverse events related to study drug

    Incidence and severity of all adverse events related to study drug

    Time frame: Time Frame: 2 years post ICI201 administration

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Study locations

1 site
  • First Affiliated Hospital, Soochow University
    Suzhou, Jiangsu 215000, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 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
NCT05980507
Lead sponsor
The First Affiliated Hospital of Soochow University
Responsible party
Sponsor
First posted
Aug 8, 2023
Start date
Oct 9, 2023 (estimated)
Primary completion
Oct 18, 2023 (estimated)
Completion
Oct 18, 2023 (estimated)
Last update
Dec 22, 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 withdrawn, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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