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

NCT05841550 | Recruiting Phase 1

• 1 other identifier: OMC04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma; Smoldering Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Percentage of participants with adverse events (AEs)

  An Adverse Event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  Baseline until 30 days after last dose of study drug, up to approximately 3 years

• Percentage of participants discontinuing treatment secondary to treatment-related adverse events

  Percentage of participants discontinuing treatment secondary to treatment-related adverse events

  Up to approximately 3 years

Secondary Outcomes (5)

• Number of patients with Progression Free Survival (PFS)

  Baseline to 11 years

• Concentration of TG01-specific T-cell specific cytokine production

  Baseline until end of study, assessed up to 11 years

• Overall response rate per patient

  Baseline to approximately 3 years

• Overall Survival (OS) per patient

  Baseline until the end of study, assessed up to 11 years

• Time to next treatment (TTNT) per patient

  Baseline until the end of study, assessed up to 11 years

Study Arms (1)

TG01

EXPERIMENTAL

TG01 is a sterile lyophilizate consisting of a mixture of seven peptides. The finished product is a white powder for injection, consisting only of the active substances containing 2.1 mg of peptides (individual peptides comprising 0.3 mg each). The lyophilizate is to be reconstituted with QS-21 for injection before use. QS-21 is a naturally occurring saponin molecule purified from the South American tree Quillaja saponaria Molina. QS-21 Solution is supplied in a 2 mL CZ resin vial as a sterile, solution in PBS (phosphate buffered saline) at a concentration of 0.5 mg/mL QS-21 (500 mcg/mL) with each vial containing 0.7 mL intended single use only. The vaccine will be given subcutaneously Treatment consists of 12 doses TG01/QS-21 vaccine given every 2 weeks in the first 12 weeks, followed by every 8 weeks until week 52. TG01 dose 0.7 mg dose and QS-21 50 ug.

Biological: TG01

Interventions

TG01 BIOLOGICAL

All participants will receive the same treatment as described under arm

TG01

Eligibility Criteria

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

You may qualify if:

• Male or female patients ≥ 18 years of age
• RAS mutation (KRAS/NRAS codon 12/13 mutation) detected on archival or fresh bone marrow material with VariantPlex Myeloid Panel
• Confirmed diagnosis of high-risk smoldering multiple myeloma (SMM) according to IMWG criteria (30) and high-risk criteria as listed up below OR confirmed diagnosis of multiple myeloma (MM) according to IMWG criteria and measurable disease following ≥
• line of treatment
• In patients with high-risk SMM at least 2 of 3 following abnormalities, based on laboratory data obtained at screening must be fulfilled:
• Serum M-protein \>20 g/L.
• Serum involved/uninvolved FLC ratio \>20.
• BMPC \>20%. OR presence of ≥10% BMPC and at least one of the following based on laboratory data obtained at screening:
• Serum M-protein ≥30 g/L (If IgA, IgA ≥20g/L)
• Serum involved/uninvolved FLC ratio ≥8 (but \<100)
• Abnormal PC immunophenotype (≥95% of BMPCs are clonal) and reduction of ≥1uninvolved Ig isotype (Only IgG, IgA and IgM will be considered)
• Progressive increase in Serum M-protein level (evolving type of SMM) defined as an increase of Serum M-protein ≥10% in the last 12 months before enrolment in the study. This increase must be consistent from one to another sample (i.e., no decrease observed between 2 increased Serum M-protein values)
• Both high-risk SMM and MM patients must have evidence of measurable disease in accordance with IMWG criteria
• If patient with MM was eligible for ASCT, ASCT must have been performed, and patients cannot be enrolled until 3 months after ASCT
• Patient should not be expected to require immediate, subsequent line of treatment for at least 2 months

You may not qualify if:

• Pregnant or lactating women or women without a pregnancy test at baseline (postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential)
• Medical conditions such as but not limited to:
• Any uncontrolled infection
• Uncontrolled cardiac failure classification III or IV (NYHA)
• Uncontrolled systemic and gastro-intestinal inflammatory conditions
• History of adverse reactions to vaccines
• Active malignancy with worse prognosis than multiple myeloma
• Likely to require treatment intervention for multiple myeloma within two months of start of treatment with TG01/QS-21
• Known history of positive tests for HIV/AIDS, hepatitis B or C
• Planned to receive yellow fever or other live (attenuated) vaccines during the course of study
• Known hypersensitivity to QS-21.
• Only participants who are able to consent will be included in the study.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Targovax ASA: collaborator

Study Sites (1)

Oslo Myeloma Center

Oslo, Oslo County, 0450, Norway

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Smoldering Multiple Myeloma

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; Precancerous Conditions; Hypergammaglobulinemia

Study Officials

• Fredik Schjesvold, MD PhD

  Oslo Myeloma Center, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanne Norseth, MD

CONTACT

92847595; h.m.norseth@gmail.com

Hedda B Monsen

CONTACT

+4794781101; heddabemo@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Oslo Myeloma Center

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: May 3, 2023
• Study Start: May 19, 2023
• Primary Completion (Estimated): May 19, 2027
• Study Completion (Estimated): May 19, 2035
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Study protocol, Informed consent form immediate after trial is approved. Clinical trial results summary and lay person summary 12 months after end of trial date. Clinical trial results summary for an intermediate data analysis 12 months after interim data analysis date. IMPD SandE sections and Investigator Brochure 7 years after end of trial.
• Access Criteria: Anyone who wish access to the data

Locations

NO (1)