Solid TumorPhase 1ACTengineNCT03247309
TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101)
A Phase 1 study testing IMA201 Product and IMADetect® in people with Solid Tumor and Cancer, run by Immatics US, Inc. at 5 sites in 2 countries.
Trial summary
The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors that express melanoma-associated antigen 4 and/or 8 (MAGEA4/8). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Cancer, Recurrent Solid Tumors
- What is being tested?
- IMA201 Product and IMADetect®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 19 Dec 2018to 18 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years of age
- 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
- Patients must have measurable disease according to RECIST 1.1
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- Disease 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 IMA201 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
- IMA201 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 IMA201
- Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA201
- 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
Who cannot join
- 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
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- 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 to any of the 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
- 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.
- 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 IMA201 treatment
- Patients with any active viral infection
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany3 sites
Universitätsklinikum Bonn, Venusberg-Campus 1
Bonn, North Rhine-Westphalia, 53127
Universitätsklinikum Carl Gustav Carus, Fetscherstr. 74
Dresden, Saxony, 01307
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
United States2 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/Germline Antigen in Patients With Recurrent and/or Refractory Solid Tumors (ACTengine® IMA201-101)
The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors that express melanoma-associated antigen 4 and/or 8 (MAGEA4/8).
Read the detailed description
SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and the biomarkers screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of the IMA201 product.
MANUFACTURING: IMA201 product will be made from the patient's white blood cells.
TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA201 infusion to improve the duration of time that IMA201 stays in the body.
After IMA201 infusion, a low dose of IL-2 will be given twice daily for a period of time.
Patients will be closely monitored for safety and for a total of 3 years post IMA201 infusion.
- Conditions
- Solid Tumor, Cancer, Recurrent Solid Tumors, Refractory Solid Tumors
- Being tested
- IMA201 Product, IMADetect®
- Keywords
- T-cell therapy, immunotherapy, adoptive cellular therapy, T-Cell Receptor, IMA201, Cytotherapy, Cell Therapy, Gene Therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMA201 ProductBiological
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®Diagnostic test
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 clinical trials with investigational IMA201 therapy. IMADetect® is intended for investigational use only.
| Study group | Role | What they receive |
|---|---|---|
| IMA201 Product | Experimental | * Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide
* One dose of IMA201 product will be infused intravenously. Up to four dose levels will be evaluated. At least two patients per cohort will be treated.
* Post-infusion of IMA201 product, administration of low-dose recombinant human interleukin-2 Receives: Biological: IMA201 Product; Diagnostic Test: IMADetect® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AE)
Measured: up to 3 years post-treatment
Determination of the maximum tolerated dose (MTD)
Measured: until 21 days post treatment
Secondary outcomes (2)
Duration of infused T cells over time (Persistence of T cells)
Measured: up to 3 years post-treatment
Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start19 Dec 2018
- Primary completion20 Apr 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immatics US, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cedrik Britten, MD, PhD, Study director, Immatics US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247309
- Sponsor's protocol ID
- IMA201-101
- Acronym
- ACTengine
- Status last verified
- Feb 2025
- First submitted
- 1 Aug 2017
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fritsche J, Rakitsch B, Hoffgaard F, Romer M, Schuster H, Kowalewski DJ, Priemer M, Stos-Zweifel V, Horzer H, Satelli A, Sonntag A, Goldfinger V, Song C, Mahr A, Ott M, Schoor O, Weinschenk T. Translating Immunopeptidomics to Immunotherapy-Decision-Making for Patient and Personalized Target Selection. Proteomics. 2018 Jun;18(12):e1700284. doi: 10.1002/pmic.201700284. Epub 2018 Apr 10.
PubMed 29505699
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/Germline Antigen in Patients With Recurrent and/or Refractory Solid Tumors (ACTengine® IMA201-101)
- ClinicalTrials.gov ID
- NCT03247309
- Acronym / sponsor ID
- ACTengine / IMA201-101
- Conditions
- Solid Tumor, Cancer, Recurrent Solid Tumors, Refractory Solid Tumors
- Keywords
- T-cell therapy, immunotherapy, adoptive cellular therapy, T-Cell Receptor, IMA201, Cytotherapy, Cell Therapy, Gene Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Immatics US, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors that express melanoma-associated antigen 4 and/or 8 (MAGEA4/8).
Detailed description
SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and the biomarkers screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of the IMA201 product.
MANUFACTURING: IMA201 product will be made from the patient's white blood cells.
TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA201 infusion to improve the duration of time that IMA201 stays in the body.
After IMA201 infusion, a low dose of IL-2 will be given twice daily for a period of time.
Patients will be closely monitored for safety and for a total of 3 years post IMA201 infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMA201 Product | Experimental | Biological: IMA201 Product, Diagnostic Test: IMADetect®* Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide * One dose of IMA201 product will be infused intravenously. Up to four dose levels will be evaluated. At least two patients per cohort will be treated. * Post-infusion of IMA201 product, administration of low-dose recombinant human interleukin-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patient ≥ 18 years of age
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMA201 ProductThe cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula. | Biological | IMA201 Product |
| 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 clinical trials with investigational IMA201 therapy. IMADetect® is intended for investigational use only. | Diagnostic test | IMA201 Product |
Primary outcome
Incidence of adverse events (AE)
Time frame: up to 3 years post-treatment
Determination of the maximum tolerated dose (MTD)
Time frame: until 21 days post treatment
2 secondary outcomes
Duration of infused T cells over time (Persistence of T cells)
Time frame: up to 3 years post-treatment
Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST)
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Derived from this study: PubMed 29505699Fritsche J, Rakitsch B, Hoffgaard F, Romer M, Schuster H, Kowalewski DJ, Priemer M, Stos-Zweifel V, Horzer H, Satelli A, Sonntag A, Goldfinger V, Song C, Mahr A, Ott M, Schoor O, Weinschenk T. Translating Immunopeptidomics to Immunotherapy-Decision-Making for Patient and Personalized Target Selection. Proteomics. 2018 Jun;18(12):e1700284. doi: 10.1002/pmic.201700284. Epub 2018 Apr 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cedrik Britten, MD, PhD study director
Immatics US, Inc.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMA201 Product and IMADetect® in people with Solid Tumor and Cancer, run by Immatics US, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AE) (time frame: up to 3 years post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03247309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.