Clinical trial · Interventional
A Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma
A Multicenter, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-034 in Patients With Relapsed/Refractory Multiple Myeloma
NCT06049290CI-TRIAL-00126040recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
This trial is a single-arm, open-label, multicenter phase I/II clinical study of LBL-034 in patients with RRMM to evaluate the safety, tolerability, PK profile, immunogenicity and efficacy of LBL-034.
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 |
|---|---|---|---|
| LBL-034 for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LBL-034
- description
- LBL-034 for Injection; Q2W
- interventionNames
- Drug: LBL-034 for Injection
Primary outcomes (4)
- measure
- Objective Response Rate (ORR)
- timeFrame
- From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy).
- description
- ORR \[including the rates of Strin-gent complete response(sCR),complete response (CR) ,Very good partial response(VGPR),and partial response (PR)\], evaluated based on the 2016 IMWG criteria(Cohorts 1, 2, and 3) and 2013 IMWG criteria(Cohort 4), refers to the percentage of study subjects who achieve a complete response or partial response. It was used to evaluate the efficacy of LBL-034 in Phase II study .
- measure
- Dose-limiting toxicities(DLT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll in the study, and sign the written informed consent form; 2. Age ≥ 18 years at the time of signing the informed consent; 3. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale≤ 1; 4. Documentation of initial diagnosis of multiple myeloma according to IMWG diagnostic criteria,or according to the IMWG 2021 diagnostic criteria, the proportion of circulating plasma cells in peripheral blood is ≥ 5%,have documentation to diagnose PCL; 5. Have a life expectancy of at least 12 weeks; 6. Fertile men and women of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine devices, hormonal contraception, and correct use of condoms) from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. Blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug. Exclusion Criteria: 1. Subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug,or require elective surgery during the trial period; 2. Use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin-2, and interferon; 3. Systemic use of corticosteroids or other immunosuppressants within 14 days prior to the initial use of the investigational drug;The following conditions are excluded: Treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term use of glucocorticoids for preventive therapy (e.g., to prevent contrast allergy); 4. Patients with active hepatitis B or C; 5. Subjects with an active infection that currently requires anti infective therapy; 6. The patient has a Medical history of immunodeficiency, including HIV antibody positive; 7. Women during pregnancy or lactation; 8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.