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JOURNAL ONKOLOGIE – STUDIE
ACTengine

ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors

Rekrutierend

NCT-Nummer:
NCT03686124

Studienbeginn:
Mai 2019

Letztes Update:
25.10.2023

Wirkstoff:
IMA203 Product, IMA203CD8 Product, nivolumab (Opdivo®)

Indikation (Clinical Trials):
Recurrence

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Immatics US, Inc.

Collaborator:
-

Studienleiter

Cedrik Britten, M.D.
Study Director
Immatics US, Inc.

Kontakt

Studienlocations
(3 von 9)

Onkologisches Zentrum Universitätsklinikum Würzburg
Josef-Schneider-Straße 6
97080 Würzburg
DeutschlandRekrutierend» Google-Maps
Universitätsklinikum Bonn - Medizinische Klinik III
53127 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum C.-G.-Carus Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Charité Benjamin Franklin - Klinik für Hämatologie und Onkologie
12203 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Brustzentrum am Universitätsklinikum Hamburg-Eppendorf
Martinistraße 52
20251 Hamburg
DeutschlandRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

SCREENING: Patient eligibility will be determined by protocol inclusion/exclusion criteria

including HLA (human leukocyte antigen) screening and a biopsy (or collection of archival

tumor tissue) for biomarker screening. If the patient is eligible, white blood cells will be

taken during leukapheresis for the manufacture of an IMA203 or an IMA203CD8 product.

MANUFACTURING: IMA203 and IMA203CD8 products will be made from the patients' white blood

cells.

TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days

before the IMA203/IMA203CD8 product infusion to improve the duration of time that

IMA203/IMA203CD8 product stays in the body. The patient will be admitted to the hospital

during the T-cell infusion.

After the IMA203/IMA203CD8 product infusion, a low dose of IL-2 will be given subcutaneously

daily for 10 days.

In Extension Cohort B (IMA203) nivolumab will be administered intravenously.

Patients will be monitored closely throughout the study. The follow-up phase ends 5 years

post infusion.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients must have recurrent/progressing and/or refractory solid tumors and must have

received or not be eligible for all available indicated standard of care treatment.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- HLA phenotype positive for the study

- Measurable disease according to RECIST 1.1

- Adequate selected organ function per protocol

- Patient's tumor must express tumor antigen by "IMADetect® RT-qPCR

- Life expectancy more than 3 months

- Female patient of childbearing potential must use adequate contraception prior to

study entry until 12 months after the infusion of IMA203/IMA203CD8

- Male patient must agree to use effective contraception or be abstinent while on study

and for 6 months after the infusion of IMA203/IMA203CD8

- The patient must have recovered from any side effects of prior therapy to Grade 1 or

lower prior to lymphodepletion.

Exclusion Criteria:

- History of other malignancies (except for adequately treated basal or squamous cell

carcinoma or carcinoma in situ) within the last 3 years

- Pregnant or breastfeeding

- Serious autoimmune disease Note: At the discretion of the investigator, these patients

may be included if their disease is well controlled without the use of

immunosuppressive agents.

- History of cardiac conditions as per protocol

- Prior stem cell transplantation or solid organ transplantation

- Concurrent severe and/or uncontrolled medical disease that could compromise

participation in the study

- History of or current immunodeficiency disease or prior treatment compromising immune

function at the discretion of the treating physician

- Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis

C virus (HCV) infection.

- Patients with LDH greater than 2.5-fold ULN.

- Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or

IMA203/IMA203CD8 treatment

- Patients with active brain metastases

- Concurrent treatment in another clinical trial.

- For nivolumab treatment, patients must not have a history of severe immune-related

toxicities, defined as any Grade 3 or 4 toxicities related to prior PD1/PD-L1

inhibitor therapy (e.g., atezolizumab, pembrolizumab or nivolumab etc.).

Other protocol defined inclusion/exclusion criteria could apply

Studien-Rationale

Primary outcome:

1. Evaluate safety and tolerability of treatment with treatment with ACTengine® IMA203/IMA203CD8 products as monotherapy or in combination with nivolumab (Time Frame - 35 days):
Treatment emergent adverse events

2. Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8 (Time Frame - 28 days):
Number of patients with dose-limiting toxicities (DLTs)

Secondary outcome:

1. Persistence of T-cells (Time Frame - up to 5 years post treatment):
Measurement of TCR-engineered T cells in peripheral blood

2. Tumor response (Time Frame - up to 12 months):
Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

3. Tumor response (Time Frame - up to 12 months):
Immune-Related Response Evaluation Criteria In Solid Tumors (irRECIST)

Studien-Arme

  • Experimental: Dose Escalation A
    Dose escalation of IMA203
  • Experimental: Extension Cohort A
    IMA203 at RP2D
  • Experimental: Extension Cohort B
    IMA203 at RP2D + nivolumab
  • Experimental: Extension Cohort C
    IMA203CD8 at provisional RP2D
  • Experimental: Dose Escalation B
    Dose escalation of IMA203CD8

Geprüfte Regime

  • IMA203 Product:
    The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.
  • IMA203CD8 Product:
    The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.
  • IMADetect®:
    IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in Immatics clinical trials. IMADetect® is intended for investigational use only.
  • nivolumab (Opdivo®) (Opdivo®):
    Nivolumab will be given post IMA203 infusion, after hematologic recovery is achieved. Clinical supply provided by Bristol Myers Squibb.

Quelle: ClinicalTrials.gov


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