NL-OMON54560
Recruiting
Phase 2
A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma - Talquetamab
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- Janssen-Cilag
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.\>\=18 years of age.
- •2\.Documented initial diagnosis of multiple myeloma according to IMWG diagnostic
- •criteria (attachment 8 of the protocol)
- •3\. Part 1: Subjects with measurable multiple myeloma who have progressed on, or
- •could not tolerate, all available established therapies.
- •Part 2: Subjects with multiple myeloma measurable by central laboratory
- •assessment who have progressed on, or could not tolerate, all available
- •established therapies. If central laboratory assessments are not available,
- •relevant local laboratory measurements must exceed the minimum required level
- •by at least 25%.
Exclusion Criteria
- •1\. 1\. Prior Grade 3 or higher CRS related to any T cell redirection (eg, CD\-3
- •redirection technology or CAR\-T cell therapy) or any prior GPRC5D targeting
- •2\. Prior antitumor therapy as follows, prior to the first dose of study drug:,
- •Gene modified adoptive cell therapy (eg, chimeric antigen receptor modified
- •T cells, natural killer \[NK] cells) within 3 months.
- •Targeted therapy, epigenetic therapy, or treatment with an, investigational
- •drug or an invasive investigational medical device within, 21 days or at least
- •5 half\-lives, whichever is less., •Monoclonal antibody treatment for multiple
- •myeloma within 21 days.,
- •Cytotoxic therapy within 21 days., • Proteasome inhibitor therapy within 14
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Talquetamab (GPRC5D and CD3 antibody) in Relapsed or Refractory Multiple MyelomaMultiple myelomaTherapeutic area: Diseases [C] - Neoplasms [C04]CTIS2023-504581-29-00Janssen - Cilag International308
Active, not recruiting
Phase 1
A Dose Escalation Study of Talquetamab in Participants with Relapsed or Refractory Multiple MyelomaEUCTR2017-002400-26-DEJanssen-Cilag International NV718
Active, not recruiting
Phase 1
A Dose Escalation Study of Talquetamab in Participants with Relapsed or Refractory Multiple MyelomaRelapsed or Refractory Multiple MyelomaMedDRA version: 20.0Level: HLGTClassification code 10005330Term: Blood and lymphatic system disorders congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Cancer [C04]EUCTR2017-002400-26-NLJanssen-Cilag International NV718
Active, not recruiting
Phase 1
An Open label Study of Teclistamab in Subjects with Relapsed and Refractory Multiple MyelomaRelapsed or Refractory Multiple MyelomaMedDRA version: 20.0Level: HLGTClassification code 10005330Term: Blood and lymphatic system disorders congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Cancer [C04]EUCTR2016-002122-36-DEJanssen-Cilag International NV473
Active, not recruiting
Phase 1
A dose-finding study to evaluate mRNA-3210 in participants with phenylketonuriaCTIS2023-506963-32-00Moderna Therapeutics Inc.54