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

NCT06880601 | Not Yet Recruiting Phase 2

• 1 other identifier: MM0125
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Multiple Myleoma; Multiple Myeloma in Relapse; Multiple Myeloma Refractory

Keywords

Multiple Myeloma; Relapse; Refractoriness; Teclistamab; Autologous lymphocyte infusion

Outcome Measures

Primary Outcomes (1)

• Duration of response

  Duration of response is the time interval between the date of confirmed response at cycle 5 and the date of documented disease progression or death from any cause, whichever occurs first. Patients who have not progressed or died at the time of analysis will be censored at the date of their last disease evaluation.

  24 months from the beginning of Te monotherapy

Study Arms (1)

Combination of Te and ALI

EXPERIMENTAL

Teclistamab plus autologous lymphocyte infusions

Drug: Teclistamab

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.

Combination of Te and ALI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has a confirmed diagnosis of MM according to the WHO 2022 classification (18)
• Patient age is ≥ 18 years of age
• Patient has a Relapsed or refractory disease as defined below:
• Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease by the International Myeloma Working Group (IMWG) (15) criteria \>60 days after cessation of treatment
• Refractory disease is defined as failure to achieve a response or confirmed progressive disease by IMWG criteria (15) during previous treatment or ≤60 days after cessation of treatment.
• Previous treatment with 1 or 2 lines of treatment (induction plus autologous stem cell transplant plus consolidation and maintenance has to be considered one single line)
• Previous triple exposure that included an IMID, a PI, and an anti-CD38 antibody (patients with no response or relapse after front line therapy with Dara-VTD or Dara-VRD are eligible)
• Progressive active symptomatic disease
• Patient has measurable disease as defined by any of the following:
• Serum M-protein level ≥0.5 g/dL; or
• Urine M-protein level ≥200 mg/24 hours; or
• Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• Able to adhere to the study visit schedule and all the other protocol procedures and requirements;
• Patient has the following laboratory parameters:

You may not qualify if:

• Previous treatment with \> 2 lines of therapy
• Patient has active central nervous system involvement with MM
• Received any prior BCMA-directed therapy
• Received the following prior antimyeloma therapy, within the specified time frame prior to enrollment:
• Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less
• Investigational vaccine within 4 weeks
• Monoclonal antibody therapy within 21 days
• Cytotoxic therapy within 21 days
• PI therapy within 14 days
• IMiD agent therapy within 14 days
• Radiotherapy within 14 days or focal radiation within 7 days
• Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months
• Stem cell transplant:
• previous allogeneic stem cell transplant
• autologous stem cell transplant performed within 12 weeks

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesco Zaja

  ASUGI - Azienda Sanitaria Universitaria Giuliano Isontina Ospedale Maggiore, Trieste

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Fazi

CONTACT

00390670390528; p.fazi@gimema.it

Enrico Crea

CONTACT

00390670390514; e.crea@gimema.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 17, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share