ACTengine® IMA203 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors (ACTengine)
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ClinicalTrials.gov Identifier: NCT03686124 |
Recruitment Status :
Recruiting
First Posted : September 26, 2018
Last Update Posted : May 27, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Refractory Cancer Recurrent Cancer Solid Tumor, Adult Cancer | Biological: IMA203 Product Device: IMADetect® Drug: nivolumab (Opdivo®) | Phase 1 |
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 nivolumab), nivolumab will be administered intravenously.
Patients will be monitored closely throughout the study. The follow-up phase ends 5 years post infusion.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a TCR Recognizing a Cancer/Germline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and/or Refractory Solid Tumors |
Actual Study Start Date : | May 14, 2019 |
Estimated Primary Completion Date : | December 2028 |
Estimated Study Completion Date : | December 2028 |

Arm | Intervention/treatment |
---|---|
Experimental: Dose Escalation
Dose escalation of IMA203
|
Biological: 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. Device: 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. |
Experimental: Extension Cohort A
IMA203 at RP2D
|
Biological: 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. Device: 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. |
Experimental: Extension Cohort B
IMA203 at RP2D + nivolumab
|
Biological: 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. Device: 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. Drug: nivolumab (Opdivo®) Nivolumab will be given post IMA203 infusion, after hematologic recovery is achieved. Clinical supply provided by Bristol Myers Squibb.
Other Name: Opdivo® |
- Incidence of adverse events (AE) [ Time Frame: up to 5 years post treatment ]
- Persistence of T-cells [ Time Frame: up to 5 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- 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
- 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
- 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
- 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 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 who have received more than 4 prior systemic treatment lines for treatment of advanced and/or metastatic disease.
- Patients who are known to have at least one single tumor lesion that exceeds 10 cm in diameter
- Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or IMA203 treatment
- Patients with active brain metastases
- Concurrent participation in an interventional part of 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686124
Contact: Jorge Rivas, M.D., Ph.D. | 346-204-5350 | ctgovinquiries@immatics.com |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact 212-342-5162 cancerclinicaltrials@cumc.columbia.edu | |
Principal Investigator: Ran Reshef, MD | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Jason Luke, M.D. 412-623-6132 lukejj@upmc.edu | |
Principal Investigator: Jason Luke, M.D. | |
United States, Texas | |
University of Texas MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Dejka M Araujo, M.D. 713-792-3626 daraujo@mdanderson.org | |
Principal Investigator: Dejka M Araujo, M.D. | |
Germany | |
Universitätsklinikum Regensburg, Franz-Josef-Strauß-Allee 11 | Not yet recruiting |
Regensburg, Bavaria, Germany, 93053 | |
Contact: Daniel Heudobler, MD +49 (0)941 944-14800 daniel.heudobler@ukr.de | |
Principal Investigator: Daniel Heudobler, MD | |
Universitätsklinikum Würzburg | Recruiting |
Würzburg, Bavaria, Germany, 97080 | |
Contact chatterjee_m@ukw.de | |
Contact +49 (0)931 201 40953 | |
Principal Investigator: Manik Chatterjee, MD | |
Universitätsklinikum Bonn - Medizinische Klinik III | Recruiting |
Bonn, North Rhine-Westphalia, Germany, 53127 | |
Contact +49 (0)228 287-17233 tobias.holderried@ukbonn.de | |
Contact +49 (0)151 44048451 | |
Principal Investigator: Tobias Holderried, MD, PhD | |
Universitätsklinikum C.-G.-Carus Dresden | Recruiting |
Dresden, Saxony, Germany, 01307 | |
Contact +49 (0)351 458 7566 Martin.Wermke@uniklinikum-dresden.de | |
Principal Investigator: Martin Wermke, MD, PhD | |
Universitätsklinikum Hamburg-Eppendorf | Recruiting |
Hamburg, Germany, 20246 | |
Contact +49 (0)40 7410 - 52960 c.bokemeyer@uke.de | |
Contact +49 (0)40 7410 - 53962 | |
Principal Investigator: Carsten Bokemeyer, MD, PhD |
Study Director: | Cedrik Britten, M.D. | Immatics US, Inc. |
Responsible Party: | Immatics US, Inc. |
ClinicalTrials.gov Identifier: | NCT03686124 |
Other Study ID Numbers: |
IMA203-101 |
First Posted: | September 26, 2018 Key Record Dates |
Last Update Posted: | May 27, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
T-cell therapy immunotherapy |
Recurrence Disease Attributes Pathologic Processes Nivolumab |
Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |