Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study ID
NCT06880601
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Multiple Myeloma Refractory
  • Multiple Myeloma in Relapse
  • Multiple Myleoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Teclistamab — DRUG
    Participants are planned to receive Te monotherapy during the first 5 cycles of treatment (1 cycle= 28 days) Participants will receive Te sc monotherapy consisting of 2 step-up doses (0.06 and 0.3 mg/kg) followed by a weekly treatment dose of 1.5 mg/kg for the first 2 cycles From cycle 3 Day 1, participants will receive Te sc Q2W at the dose of 3 mg/kg- From cycle 7 Day 1, participants will receive Te sc Q4W at the dose of 3 mg/kg. After cycle 5, participants in PR or better will continue treatment with Te in combination with 4 Ali infusions (cycles +6, +9, +12, +15). The four doses of ALI will be administered with increasing dosage during Te treatment as follows: * before Te Cycle 6: ALI 10 x 10\^6/kg * before Te Cycle 9: ALI 20 x 10\^6/kg * before Te Cycle 12: ALI 30 x 10\^6/kg * before Te Cycle 15: ALI 40 x 10\^6/kg Teclistamab single agent will be continued until progression, unacceptable toxicity or patients refusal.

Study Details

The goal of this clinical trial is to evaluate the efficacy of Teclistamab (Te) and autologous lymphocyte infusions (ALI) in relapse refractory multiple myeloma. The main question it aims to answer is: which is the Duration of response (DoR) with Teclistmab and ALI? Participants will receive Te for 5 cycles. Participants in PR or better after the first five cycles of Te monotherapy will continue treatment with Te in combination with ALI administration starting from cycle 6

Key Dates

Start date
Nov 1, 2025
Status verified
Mar 2025
Primary completion
Nov 1, 2029
Completion
Nov 1, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination of Te and ALI
    Teclistamab plus autologous lymphocyte infusions

Primary Outcome Measure

Duration of response [ Time Frame: 24 months from the beginning of Te monotherapy ]

Central Contacts

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