AzTrials
AzTrials

Solid Tumor, AdultPhase 1ACTengineNCT03441100

TCR-engineered T Cells in Solid Tumors: IMA202-101

A Phase 1 study testing IMA202 Product and IMADetect® in people with Solid Tumor, Adult and Refractory Cancer, run by Immatics US, Inc. at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study purpose is to establish the safety and tolerability of IMA202 product in patients with solid tumors that express melanoma-associated antigen 1 (MAGEA1). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IMA202 Product and IMADetect®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
6 sitesin 2 countries
Study dates
2 May 2019to 17 Mar 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

  • 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
Show all 20Show fewer
  • Acceptable 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 IMA202 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
  • IMA202 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 IMA202
  • Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA202
  • 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

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
Show all 18Show fewer
  • Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
  • History of hypersensitivity to cyclophosphamide (CY), fludarabine (FLU), IL-2, or 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 IMA202 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

6 sites in 2 countries.

6 sites in 2 countries

Germany4 sites

  • Universitätsklinikum Bonn - Medizinische Klinik III

    Bonn, North Rhine-Westphalia, 53127

  • Universitätsklinikum C.-G.-Carus Dresden

    Dresden, Saxony, 01307

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

United States2 sites

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

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® IMA202-101)

The study purpose is to establish the safety and tolerability of IMA202 product in patients with solid tumors that express melanoma-associated antigen 1 (MAGEA1).

Read the detailed description

SCREENING: Patient eligibility will be determined by 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 IMA202 product.

MANUFACTURING: IMA202 product will be made from the patient's white blood cells.

TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA202 product infusion to improve the duration of time that IMA202 product stays in the body. The patient will be admitted to the hospital during the treatment.

After the IMA202 product 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 IMA202 infusion.

Being tested
IMA202 Product, IMADetect®
Keywords
T-Cell therapy, Immunotherapy, Adoptive cellular therapy, T-Cell Receptor, Cell Therapy, Cytotherapy, IMA202
Medical subject headings
Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMA202 ProductDrug

    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®Device

    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. IMADetect® is intended for investigational use only.

Study groups in NCT03441100
Study groupRoleWhat they receive
Experimental: IMA202 ProductExperimental* Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide * One dose of IMA202 product will be infused intravenously. Four dose levels will be evaluated. At least two patients per cohort will be treated. * Post-infusion of IMA202 product, administration of low dose recombinant human interleukin-2
Receives: Drug: IMA202 Product; Device: IMADetect®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AE)

    Measured: up to 3 years post treatment

Secondary outcomes (2)

  1. Persistence of T-cells

    Measured: up to 3 years post treatment

  2. 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.

  1. First posted22 Feb 2018
  2. Study start2 May 2019
  3. Primary completion17 Jun 2022
  4. Study completion17 Mar 2023

Resources

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03441100
Sponsor's protocol ID
IMA202-101
Acronym
ACTengine
Status last verified
Feb 2025
First submitted
9 Feb 2018
Last updated
4 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMA202 Product and IMADetect® in people with Solid Tumor, Adult and Refractory Cancer, run by Immatics US, Inc. at 6 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 20 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 6 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). 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 NCT03441100.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in