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CAR T-cell Therapy

Dose Exploration Phase: Forimtamig (Dose 1) + Daratumumab for Multiple Myeloma

Phase 1 & 2
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months
Awards & highlights

Study Summary

This trial aims to test the safety and effectiveness of forimtamig in treating people with relapsed or refractory multiple myeloma. Participants will receive forimtamig alone or in combination with

Who is the study for?
This trial is for people with relapsed or refractory multiple myeloma who have a good performance status, expect to live at least 12 more weeks, and have recovered from previous cancer treatments. They must have measurable disease progression after their last treatment.Check my eligibility
What is being tested?
The study tests the safety and initial effectiveness of Forimtamig alone or combined with Carfilzomib or Daratumumab in treating multiple myeloma. It has two parts: finding the right dose and then seeing how well it works at that dose.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation, infusion-related symptoms, fatigue, nausea, blood count changes, kidney or liver function alterations among others specific to each drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response (CR)/Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria
Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria
Percentage of Participants with Adverse Events (AEs)
+1 more
Secondary outcome measures
Duration of Response (DoR) for Participants who Achieve a Partial Response (PR) or Better as Determined by the Investigator per IMWG Criteria
Overall Survival (OS) as Determined by the Investigator per IMWG Criteria
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig
+4 more

Trial Design

9Treatment groups
Experimental Treatment
Group I: Dose Exploration Phase: Forimtamig (Dose 3) + DaratumumabExperimental Treatment2 Interventions
Participants will receive Dose 3 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.
Group II: Dose Exploration Phase: Forimtamig (Dose 3) + CarfilzomibExperimental Treatment2 Interventions
Participants will receive Dose 3 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.
Group III: Dose Exploration Phase: Forimtamig (Dose 2) + DaratumumabExperimental Treatment2 Interventions
Participants will receive Dose 2 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.
Group IV: Dose Exploration Phase: Forimtamig (Dose 2) + CarfilzomibExperimental Treatment2 Interventions
Participants will receive Dose 2 of forimtamig, SC injection in combination with carfilzomib, IV infusion until disease progression.
Group V: Dose Exploration Phase: Forimtamig (Dose 1) + DaratumumabExperimental Treatment2 Interventions
Participants will receive Dose 1 of forimtamig, SC injection in combination with daratumumab, SC injection until disease progression.
Group VI: Dose Exploration Phase: Forimtamig (Dose 1) + CarfilzomibExperimental Treatment2 Interventions
Participants will receive Dose 1 of forimtamig, subcutaneous (SC) injection in combination with carfilzomib, intravenous (IV) infusion until disease progression.
Group VII: Dose Expansion Phase: Forimtamig + DaratumumabExperimental Treatment2 Interventions
Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with daratumumab, SC injection until disease progression.
Group VIII: Dose Expansion Phase: Forimtamig + CarfilzomibExperimental Treatment2 Interventions
Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase in combination with carfilzomib, IV infusion until disease progression.
Group IX: Dose Expansion Phase: ForimtamigExperimental Treatment1 Intervention
Participants will receive forimtamig, SC injection at a fixed dose determined during dose exploration phase until disease progression or completion of 12 months of treatment, whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2017
Completed Phase 3
~1400
Daratumumab
2014
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,091,076 Total Patients Enrolled
13 Trials studying Multiple Myeloma
2,169 Patients Enrolled for Multiple Myeloma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,720 Total Patients Enrolled
19 Trials studying Multiple Myeloma
2,892 Patients Enrolled for Multiple Myeloma
~211 spots leftby Jun 2027
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