RecruitingPhase 1Phase 2NCT05841550

The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma

A Phase 1/Phase 2 Study to Investigate Safety, Tolerability and Efficacy With TG01/QS-21 Vaccine Administration in Patients With Confirmed KRAS or NRAS Codon 12/13 Mutation and High-risk Smoldering Multiple Myeloma or Multiple Myeloma and Evidence of Measurable Disease ≥ 1 Line of Treatment

Sponsor

Oslo University Hospital

Enrollment

20 participants

Start Date

May 19, 2023

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma Smoldering Multiple Myeloma

Summary

The goal of this clinical trial is to test the safety, tolerability, and efficacy of TG01 vaccination in patients with KRAS or NRAS mutation on codon 12/13 mutation who has multiple myeloma or high-risk smoldering multiple myeloma. The main question it aims to answer are: Is TG01/QS-21 vaccination safe and tolerable for this patient group? Is TG01/QS-21 vaccination treatment efficient in this group in terms of increased overall response rate, overall survival rate, progression-free survival, and time til next treatment? Is there an immunological response to the vaccine? Participants will be given TG01/QS-21 vaccination treatment. Treatment consists of 12 doses of TG01/QS-21 vaccine given every two weeks in the first 12 weeks, followed by every eight weeks until week 52.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a cancer vaccine (TG01 with QS-21 adjuvant) for people with multiple myeloma — a blood cancer affecting plasma cells in the bone marrow — who have a specific genetic mutation called RAS. The vaccine is designed to train the immune system to recognize and attack myeloma cells carrying this mutation. **You may be eligible if...** - You are 18 or older - Your bone marrow biopsy shows a RAS mutation (KRAS or NRAS codon 12 or 13) - You have high-risk smoldering multiple myeloma (a pre-cancerous stage with high risk of progressing) OR active multiple myeloma with measurable disease after at least one prior treatment **You may NOT be eligible if...** - Your myeloma does not have a RAS mutation - You have serious liver, kidney, or immune system problems - You have had certain recent treatments that would interfere with vaccine response - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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