Talquetamab + Teclistamab for Multiple Myeloma

(RedirecTT-1 Trial)

Recruiting at54 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of two drugs, talquetamab and teclistamab, in patients whose multiple myeloma has come back or did not respond to previous treatments. The drugs aim to destroy cancer cells by targeting specific proteins on their surface.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for people with multiple myeloma that's come back or hasn't responded to treatment. They should be able to perform daily activities without significant issues (ECOG grade 0-1). Participants must have been diagnosed according to specific criteria and can't join if they've had certain other conditions, recent experimental therapies, or a stem cell transplant within the last six months.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My multiple myeloma diagnosis follows international guidelines.

My condition did not improve or worsened after the last treatment.

Exclusion Criteria

I had a stem cell transplant from a donor within the last 6 months.

I haven't had targeted, epigenetic, or investigational treatments recently.

I have a specific blood cancer or related condition.

Treatment Details

Interventions

• Daratumumab (Monoclonal Antibodies)
• Talquetamab (CAR T-cell Therapy)
• Teclistamab (CAR T-cell Therapy)

Trial Overview The study is testing combinations of Talquetamab and Teclistamab in those with relapsed or refractory multiple myeloma. It aims to find the best dose and schedule, assess safety at this dose, and see how well these drugs work against cancer, especially when it has spread outside the bone marrow.

Participant Groups

Group I: Part 3: Phase 2 Experimental Treatment 2 Interventions

Participants will receive teclistamab + talquetamab combination therapy, at the RP2R selected from Part 1 and Part 2.

Group II: Part 2: Dose Expansion Experimental Treatment 3 Interventions

Participants will receive treatment doses (combination of tal+tec and dara+tal+tec regimens) which will be determined by the recommended Phase 2 regimen (s) (RP2R\[s\]) of the study treatment identified in Part 1.

Group III: Part 1: Dose Escalation Experimental Treatment 3 Interventions

Participants will receive tec+tal with or without daratumumab in 28-day cycles following initial step-up doses.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires