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RecruitingLast updated: 2 April 2024

RedirecTT-1: This study aims to identify the recommended dose schedule, safety and effectiveness of combination immunotherapy, with or without targeted therapy, in people with relapsed or refractory multiple myeloma and extramedullary diseaseA Phase 1b/2 Dose Escalation and Expansion Study of the Combination of the Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Clinical summary

Summary

What is the rationale for this study?

Multiple myeloma is a malignant plasma cell disorder that is characterised by the production of monoclonal proteins (M proteins), which are comprised of immunoglobulins (Ig) or fragments of Ig, which have subsequently lost their normal function.

The rationale for combning talquetamab and teclistamab in this study is the targeting of multiple proteins on the surface of multiple myeloma cells, resulting in cell lysis. Talquetamab and teclistamab are both bispecific antibodies, which are a new type of antibody-based immunotherapy.

How long does this study go for?

This study has 3 periods: screening phase (up to 28 days), treatment phase (start of study drug administration and continues until the completion of the end of treatment visit); and a post-treatment follow-up phase (after end of treatment and up to 16 weeks after last dose of study drug(s)). End of study is defined as 2 years after the last participant has received their initial dose of the treatment combination. Total duration of the study is approximately 5 years. 

What is involved with this study?

In Part 1 (Dose Escalation), participants will receive teclistamab and talquetamab (tec+tal) ,with or without a targeted therapy called daratumumab in 28-day cycles following initial step-up doses until the recommended Phase 2 regimen (s) (RP2R[s]) are determined. All treatments will be administered by subcutaenous (SC) injection, which means an injection under the skin.

In Part 2 (Dose Expansion), participants will receive treatment doses (combination of tec+tal and dara+tal+tec regimens) which will be determined by the RP2R(s) of the study treatment identified in Part 1. 

In Part 3, participants will receive tec+tal combination therapy, at the RP2R slected from Part 1 and Part 2. 

Conditions

This trial is treating patients with relapsed or refractory multiple myeloma and extramedullary disease

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

Trial Acronym

RedirecTT-1

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT04586426
  • CR108901; 2019-004124-38; 64007957MMY1003; 2023-503439-16-00

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 1b/2 Dose Escalation and Expansion Study of the Combination of the Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Eligibility

Inclusion

  • Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Part 1 and 2: Participant could not tolerate or has disease that is relapsed or refractory to established therapies, including the last line of therapy. Part 3: (a) Relapsed or refractory disease, and exposed to a PI, IMiD, and an anti-CD38 mAb; (b) Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
  • Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration. Part 3: ECOG performance status grade of 0, 1, or 2 at screening and immediately before the start of study drug administration

Exclusion

  • All Parts: Targeted therapy, epigenetic therapy, or treatment with an investigational treatment or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less. Part 3: prior BCMA targeted bispecific antibody therapy; prior GPRC5D targeted therapy
  • All Parts: Allogeneic stem cell transplant within 6 months before the first dose of study treatment.
  • All Parts: Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma.
  • All Parts: Active plasma cell leukemia (greater than [>]2.0*10^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M- protein, and skin changes), or primary amyloid light chain amyloidosis

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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