JOURNAL ONKOLOGIE – STUDIE
ACTengine
Cedrik Britten, M.D.
Study Director
Immatics US, Inc.
Jorge Rivas, M.D., Ph.D.
Kontakt:
Phone: 346-204-5350
E-Mail: ctgovinquiries@immatics.com» Kontaktdaten anzeigen
Studienlocations
Onkologisches Zentrum Universitätsklinikum Würzburg
Josef-Schneider-Straße 6
97080 Würzburg
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Phone: +49 931 201 0
Phone: +49 931 201 40953» Ansprechpartner anzeigen Universitätsklinikum Bonn - Medizinische Klinik III
53127 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Phone: +49 (0) 228 2870
Phone: +49 228 287 17233» Ansprechpartner anzeigen Universitätsklinikum C.-G.-Carus Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Phone: +49 351 458 7566» Ansprechpartner anzeigen Brustzentrum am Universitätsklinikum Hamburg-Eppendorf
Martinistraße 52
20251 Hamburg
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Phone: +49 (0) 40 7410-56305» Ansprechpartner anzeigen Columbia University Medical Center
10032 New York
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Phone: 212-342-5162
E-Mail: cancerclinicaltrials@cumc.columbia.edu» Ansprechpartner anzeigen University of Pittsburgh Medical Center
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jason Luke, M.D.
Phone: 412-623-6132
E-Mail: lukejj@upmc.edu» Ansprechpartner anzeigen University of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Dejka M Araujo, M.D.
Phone: 713-792-3626
E-Mail: daraujo@mdanderson.org» Ansprechpartner anzeigen Alle anzeigen
SCREENING: Patient eligibility will be determined by protocol inclusion/exclusion criteria
including HLA (human leukocyte antigen) screening and a biopsy for biomarker screening. If
the patient is eligible, white blood cells will be taken during leukapheresis for the
manufacture of the IMA203 product.
MANUFACTURING: IMA203 product will be made from the patient's white blood cells.
TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days
before the IMA203 product infusion to improve the duration of time that IMA203 product stays
in the body. The patient will be admitted to the hospital during the T-cell infusion.
After the IMA203 product infusion, a low dose of IL-2 will be given subcutaneously daily for
10 days.
In Extension Cohort B (IMA203 plus atezolizumab), atezolizumab will be administered for up to
one year.
Patients will be monitored closely throughout the study. The treatment and observation phase
ends 3 years post infusion.
- Pathologically confirmed advanced and/or metastatic solid tumor
- Patients may enter screening procedure before, during, or after the last available
indicated standard of care treatment. There is no limitation for prior anti cancer
treatments.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- HLA phenotype positive for the study
- Measurable disease and accessible to biopsy
- Adequate pulmonary function per protocol
- Adequate organ and bone marrow function per protocol
- Acceptable coagulation status per protocol
- Adequate hepatic function per protocol
- Adequate renal function per protocol
- Patient's tumor must express tumor antigen by qPCR using a fresh tumor biopsy specimen
- Life expectancy more than 3 months
- Confirmed availability of production capacities for IMA203 product
- 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.
- For hepatocellular carcinoma (HCC) patients only, Child-Pugh score of ≤ 6
- IMA203 product must have passed all of the release tests
- Female patient of childbearing potential must use adequate contraception prior to
study entry until 12 months after the infusion of IMA203
- Male patient must agree to use effective contraception or be abstinent while on study
and for 6 months after the infusion of IMA203
- Hepatocellular carcinoma (HCC) patients with liver cirrhosis only - upper endoscopy is
required within 6 months of study entry
- The patient must have recovered from any side effects of prior therapy to Grade 1 or
lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo)
prior to lymphodepletion. As determined by the investigator, the patient may still be
eligible if the patient has not fully recovered from Grade ≥ 2 toxicities if these
toxicities are not anticipated to further improve (e.g., chronic neuropathy) and such
toxicities are not anticipated to worsen with the lymphodepletion therapy
Exclusion Criteria:
- History of other malignancies (except for adequately treated basal or squamous cell
carcinoma or carcinoma in situ) within the last 3 years
- Solid tumors with low likelihood of tumor biomarker expression per protocol
- 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 hypersensitivity to cyclophosphamide (CY), fludarabine (FLU), or IL-2 or
any of these rescue medications
- History of or current immunodeficiency disease or prior treatment compromising immune
function at the discretion of the treating physician
- HIV infection, active hepatitis B virus (HBV), active hepatitis C virus (HCV)
infection, ongoing active anti-HCV treatment or detectable HBV or HCV viral load at
the most recent laboratory report. Patients with both HBV and HCV infections will be
excluded from screening
1. Patients with a history of HCV infection and with an undetectable viral load per
the most recent laboratory report and/or completed anti-HCV treatment but are HCV
antibody positive are permitted.
2. History of treated HBV infection is permitted if the viral load is undetectable
per the most recent laboratory report. Note: HCC patients with controlled HBV
infection, as defined by resolved (anti-hepatitis B surface antigen [HBs-Ag]
antibody (Ab) negative, anti-core antigen [HBc Ag] Ab positive) or chronic stable
(anti HBs-Ag Ab positive) HBV infection will be eligible for screening. Patients
with active HBV infection who are not on anti-HBV treatment will be excluded.
- Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or
IMA203 treatment
- Patients with active brain metastases
NOTE: Patients with a history of brain metastases may be eligible, if an imaging scan with
contrast enhancement not older than 4 weeks is able to exclude the existence of currently
active brain metastasis, and steroid therapy has been discontinued for ≥2 weeks.
- Treatment with protocol-defined excluded treatments, medical devices, and/or
procedures per protocol
- Concurrent participation in an interventional part of another clinical trial.
For atezolizumab treatment, patients must have adequate hematologic recovery, must have
recovered from infections to Grade 1 or lower, and 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.).
1. Incidence of adverse events (AE) (Time Frame - up to 3 years post treatment)
Secondary outcome:
1. Persistence of T-cells (Time Frame - up to 3 years post treatment)
2. Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST) (Time Frame - up to 12 months)
TCR-engineered T Cells in Solid Tumors
Rekrutierend
NCT-Nummer:
NCT03686124
Studienbeginn:
Mai 2019
Letztes Update:
12.07.2021
Wirkstoff:
IMA203 Product, Atezolizumab
Indikation (Clinical Trials):
Recurrence
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 1
Sponsor:
Immatics US, Inc.
Collaborator:
-
Studienleiter
Study Director
Immatics US, Inc.
Kontakt
Kontakt:
Phone: 346-204-5350
E-Mail: ctgovinquiries@immatics.com» Kontaktdaten anzeigen
Studienlocations
(3 von 7)
Josef-Schneider-Straße 6
97080 Würzburg
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Phone: +49 931 201 0
Phone: +49 931 201 40953» Ansprechpartner anzeigen
53127 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Phone: +49 (0) 228 2870
Phone: +49 228 287 17233» Ansprechpartner anzeigen
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Phone: +49 351 458 7566» Ansprechpartner anzeigen
Martinistraße 52
20251 Hamburg
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Phone: +49 (0) 40 7410-56305» Ansprechpartner anzeigen
10032 New York
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Phone: 212-342-5162
E-Mail: cancerclinicaltrials@cumc.columbia.edu» Ansprechpartner anzeigen
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jason Luke, M.D.
Phone: 412-623-6132
E-Mail: lukejj@upmc.edu» Ansprechpartner anzeigen
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Dejka M Araujo, M.D.
Phone: 713-792-3626
E-Mail: daraujo@mdanderson.org» Ansprechpartner 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 for biomarker screening. If
the patient is eligible, white blood cells will be taken during leukapheresis for the
manufacture of the IMA203 product.
MANUFACTURING: IMA203 product will be made from the patient's white blood cells.
TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days
before the IMA203 product infusion to improve the duration of time that IMA203 product stays
in the body. The patient will be admitted to the hospital during the T-cell infusion.
After the IMA203 product infusion, a low dose of IL-2 will be given subcutaneously daily for
10 days.
In Extension Cohort B (IMA203 plus atezolizumab), atezolizumab will be administered for up to
one year.
Patients will be monitored closely throughout the study. The treatment and observation phase
ends 3 years post infusion.
Ein-/Ausschlusskriterien
Inclusion Criteria:- Pathologically confirmed advanced and/or metastatic solid tumor
- Patients may enter screening procedure before, during, or after the last available
indicated standard of care treatment. There is no limitation for prior anti cancer
treatments.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- HLA phenotype positive for the study
- Measurable disease and accessible to biopsy
- Adequate pulmonary function per protocol
- Adequate organ and bone marrow function per protocol
- Acceptable coagulation status per protocol
- Adequate hepatic function per protocol
- Adequate renal function per protocol
- Patient's tumor must express tumor antigen by qPCR using a fresh tumor biopsy specimen
- Life expectancy more than 3 months
- Confirmed availability of production capacities for IMA203 product
- 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.
- For hepatocellular carcinoma (HCC) patients only, Child-Pugh score of ≤ 6
- IMA203 product must have passed all of the release tests
- Female patient of childbearing potential must use adequate contraception prior to
study entry until 12 months after the infusion of IMA203
- Male patient must agree to use effective contraception or be abstinent while on study
and for 6 months after the infusion of IMA203
- Hepatocellular carcinoma (HCC) patients with liver cirrhosis only - upper endoscopy is
required within 6 months of study entry
- The patient must have recovered from any side effects of prior therapy to Grade 1 or
lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo)
prior to lymphodepletion. As determined by the investigator, the patient may still be
eligible if the patient has not fully recovered from Grade ≥ 2 toxicities if these
toxicities are not anticipated to further improve (e.g., chronic neuropathy) and such
toxicities are not anticipated to worsen with the lymphodepletion therapy
Exclusion Criteria:
- History of other malignancies (except for adequately treated basal or squamous cell
carcinoma or carcinoma in situ) within the last 3 years
- Solid tumors with low likelihood of tumor biomarker expression per protocol
- 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 hypersensitivity to cyclophosphamide (CY), fludarabine (FLU), or IL-2 or
any of these rescue medications
- History of or current immunodeficiency disease or prior treatment compromising immune
function at the discretion of the treating physician
- HIV infection, active hepatitis B virus (HBV), active hepatitis C virus (HCV)
infection, ongoing active anti-HCV treatment or detectable HBV or HCV viral load at
the most recent laboratory report. Patients with both HBV and HCV infections will be
excluded from screening
1. Patients with a history of HCV infection and with an undetectable viral load per
the most recent laboratory report and/or completed anti-HCV treatment but are HCV
antibody positive are permitted.
2. History of treated HBV infection is permitted if the viral load is undetectable
per the most recent laboratory report. Note: HCC patients with controlled HBV
infection, as defined by resolved (anti-hepatitis B surface antigen [HBs-Ag]
antibody (Ab) negative, anti-core antigen [HBc Ag] Ab positive) or chronic stable
(anti HBs-Ag Ab positive) HBV infection will be eligible for screening. Patients
with active HBV infection who are not on anti-HBV treatment will be excluded.
- Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or
IMA203 treatment
- Patients with active brain metastases
NOTE: Patients with a history of brain metastases may be eligible, if an imaging scan with
contrast enhancement not older than 4 weeks is able to exclude the existence of currently
active brain metastasis, and steroid therapy has been discontinued for ≥2 weeks.
- Treatment with protocol-defined excluded treatments, medical devices, and/or
procedures per protocol
- Concurrent participation in an interventional part of another clinical trial.
For atezolizumab treatment, patients must have adequate hematologic recovery, must have
recovered from infections to Grade 1 or lower, and 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.).
Studien-Rationale
Primary outcome:1. Incidence of adverse events (AE) (Time Frame - up to 3 years post treatment)
Secondary outcome:
1. Persistence of T-cells (Time Frame - up to 3 years post treatment)
2. Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST) (Time Frame - up to 12 months)
Studien-Arme
- Experimental: Dose Escalation
Dose escalation of IMA203 - Experimental: Extension Cohort A
IMA203 at MTD - Experimental: Extension Cohort B
IMA203 at MTD + atezolizumab
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. - 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. - Atezolizumab (Tecentriq):
Atezolizumab will be given post IMA203 infusion, after hematologic recovery is achieved, for up to a year after IMA203 infusion.
Quelle: ClinicalTrials.gov
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