Clinical trial • Phase I/II • Oncology

AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIGENS for Solid tumors

Phase I/II trial of AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIG…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Solid tumors
Trial Stage
Phase I/II
Drug Modality
Cell therapy|Monoclonal antibody

Key dates

Initial CTIS Submission Date
14-08-2024
First CTIS Authorization Date
27-08-2024

Trial design

open-label, none/not specified-controlled, adaptive Phase I/II trial across 10 sites in Germany.

Open Label
Yes
Comparator
None/Not specified
Adaptive
True, dose escalation/de-escalation design to identify MTD and/or RP2D; Phase Ia dose escalation with Phase Ib extension cohorts and subsequent Phase II cohorts
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
272

Eligibility

Recruits 272 The registry indicates a vulnerable population selection (isVulnerablePopulationSelected = true). Subject information and informed consent forms are provided (multiple L1/L2 documents listed) including an ICF document for a legal guardian ("L1_SIS and ICF_adults legal guardian_DE_EN_redacted"). Available consent documents are provided in German and English (DE/EN versions listed)..

Pregnancy Exclusion
The patient is pregnant or is breastfeeding
Vulnerable Population
The registry indicates a vulnerable population selection (isVulnerablePopulationSelected = true). Subject information and informed consent forms are provided (multiple L1/L2 documents listed) including an ICF document for a legal guardian ("L1_SIS and ICF_adults legal guardian_DE_EN_redacted"). Available consent documents are provided in German and English (DE/EN versions listed).

Inclusion criteria

  • {"criterion_text":"- Patient must have pathologically confirmed advanced and/or metastatic solid tumor with defined tumor target expression"}
  • {"criterion_text":"- Patients ≥ 18 years of age"}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1"}
  • {"criterion_text":"- Confirmed HLA status"}
  • {"criterion_text":"- Adequate hepatic and renal function, acceptable coagulation status and adequate organ and marrow function"}
  • {"criterion_text":"- Patients must have measurable disease according to RECIST 1.1"}
  • {"criterion_text":"- Patients must have recovered from infections to Grade 1 or lower (Nivolumab combination arm)"}

Exclusion criteria

  • {"criterion_text":"- Patients with history of other malignancies or with active brain metastases"}
  • {"criterion_text":"- The patient is pregnant or is breastfeeding"}
  • {"criterion_text":"- Patients with prior allogenic stem cell transplantation or solid organ transplantation"}
  • {"criterion_text":"- History of hypersensitivity to CY, FLU or IL-2 and Rescue medication"}
  • {"criterion_text":"- The patient has concurrent severe and/or uncontrolled medical disease or any other condition that would, in the investigator's or sponsor's judgment, contraindicate the patient's participation in the clinical study because of safety concerns or compliance with clinical study procedures"}
  • {"criterion_text":"- Patients with a history of severe immune-related toxicities, defined as any Grade 3 or 4 toxicities related to prior PD1/PD-L1 inhibitor therapy (Nivolumab combination arm)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Treatment-emergent adverse events (TEAEs) (Phase I/II)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Adverse Events of special interest (AESIs) (Phase I/II)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Serious TEAEs (Phase I/II)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of patients with dose-limiting toxicities (Phase I)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Objective response rate based on best overall response of complete response and partial response centrally assessed using RECIST 1.1 (Phase II)","definition_or_measurement_approach":"Objective response rate defined as best overall response of complete response and partial response, centrally assessed using RECIST v1.1"}

Recruitment

Planned Sample Size
272
Recruitment Window Months
146
Consent Approach
Informed consent is obtained from adult participants (inclusion criteria specify Patients ≥ 18 years of age). Multiple Subject Information and ICF documents are listed (L1/L2), including an ICF for a legal guardian and materials in German and English (DE/EN). Specific assent procedures for minors are not applicable (study population ≥18).

Geography

Total Number Of Sites
10
Total Number Of Participants
272

Germany

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
680
Number Of Sites
10
Number Of Participants
272

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Medizinische Klinik
Contact Person Name
Carsten Bokemeyer
Contact Person Email
c.bokemeyer@uke.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
III. Medizinische Klinik und Poliklinik
Contact Person Name
Eva Maria Wagner-Drouet
Contact Person Email
eva.wagner@unimedizin-mainz.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie
Contact Person Name
Peter Herhaus
Contact Person Email
peter.herhaus@mri.tum.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Nationales Centrum für Tumorerkrankungen (NCT)
Contact Person Name
Dirk Jäger
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Hämatologie und Onkologie CCC
Contact Person Name
Antonia Busse
Contact Person Email
antonia.busse@charite.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Early Clinical Trial Unit (NCT/UCC ECTU)
Contact Person Name
Martin Wermke
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik III, Abt. für Hämatologie, Onkologie und Rheumatologie
Contact Person Name
Friederike Schmitz
Contact Person Email
Friederike.Schmitz@ukbonn.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Interdisziplinäres Studienzentrum mit ECTU
Contact Person Name
Manik Chatterjee
Contact Person Email
isz_koordination@ukw.de
Site Name
Universitaetsklinikum Bonn AöR (duplicate entry not present)
Site Name
Universitaetsklinikum Wuerzburg AöR (duplicate entry not present)

Sponsor

Primary sponsor

Full Name
Immatics US Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Third parties

  • {"country":"Germany","full_name":"Genewiz Germany GmbH","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Quanticate UK Limited","duties_or_roles":"Biostatistic; code:6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Imaging Endpoints II LLC","duties_or_roles":"Central Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Precision for Medicine GmbH","duties_or_roles":"Sample logistics and storage","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"System Provider; code:7","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Scope International AG","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Cogitars GmbH","duties_or_roles":"code:10","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"MicroCoat Biotechnologie GmbH","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Winicker-Norimed Medizinische Forschung GmbH","duties_or_roles":"code:11","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Angle Europe Limited","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"ProtaGene CGT GmbH","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"spm²-safety projects & more GmbH","duties_or_roles":"code:8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"The University of Texas MD Anderson Cancer Center","duties_or_roles":"code:4","organisation_type":"Educational Institution"}

Investigational products

Investigational Product Name
IMA203
Active Substance
AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIGENS
Modality
Cell therapy
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
First In Human
Yes
Investigational Product Name
IMA203CD8
Active Substance
IMA203CD8
Modality
Cell therapy
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
First In Human
Yes
Investigational Product Name
OPDIVO 10 mg/mL concentrate for solution for infusion.
Active Substance
NIVOLUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Authorisation Status
Marketing authorisation EU/1/15/1014/002
Combination Treatment
Yes

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