NCT06880601

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

Teclistamab Plus Autologous Lymphocytes Infusion for the Treatment of Relapse/Refractory Multiple Myeloma (TALIM)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a prospective, multicenter, single arm, phase II trial designed to evaluate the efficacy and safety of the combination of Te and ALI. This combination will be tested in patients with RRMM who are at least in partial response (PR) according to the IMWG criteria after 5 cycles of treatment with Te single agent. Participants are planned to receive Te monotherapy during the first five cycles of treatment (1 cycle= 28 days) After cycle 5: Participants in PR or better will continue treatment with Te in combination with 4 Q12W ALI administration starting from cycle 6 (cycles +6, +9, +12, +15); Participants with \< PR after the first five cycles of Te monotherapy (Minimal Response, Stable Disease) will be allowed to continue treatment with Te monotherapy; After cycle 15: Patients with PR or better will continue Te monotherapy up to progressive disease, unacceptable toxicity, patients' refusal Patients with \< PR (Minimal Response, Stable Disease) will be allowed to continue treatment with Te monotherapy up to progressive disease, unacceptable toxicity, patients' refusal Patients with progressive disease (PD) will stop Te, go off treatment and will be treated according to investigator choice Final evaluation will be performed after the end of Te cycle 24.

Conditions

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

Interventions

Type	Name	Description
DRUG	Teclistamab	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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2029-11-01
• Completion: 2029-11-01
• First posted: 2025-03-17
• Last updated: 2025-04-03