Clinical trial · Interventional
Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y001#
An Open, Single-arm Clinical Study Evaluating the Safety and Efficacy of IBI346 Infusion in Relapsed/Refractory Multiple Myelom
NCT05270928CI-TRIAL-00068269completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI346 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IBI346
- description
- Single arm
- interventionNames
- Drug: IBI346
Primary outcomes (3)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- 21 days post IBI346 administration
- measure
- Incidence and severity of adverse events: Proportion of subjects with treatment-related adverse events assessed by NCI-CTCAE v5.0 criteria
- timeFrame
- 2 years post IBI346 administration
- measure
- Presence or absence of replication-competent lentivirus (RCL)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: 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).
References
Publications (0)
Data not yet available
No reference posted for this study.