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CancerPhase 1ACTologNCT02876510

ACTolog in Patients With Solid Cancers

A Phase 1 study testing Fludarabine, Cyclophosphamide and IMA101 product in people with Cancer and Solid Tumor, run by Immatics US, Inc. at 1 site in United States.

Completed

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

Official record
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Trial summary

The study purpose is to learn about the safety and tolerability of IMA101 alone (Cohort 1) or in combination with atezolizumab (Cohort 2) in patients with advanced solid cancers that express pre-defined Immatics tumor targets. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cancer, Solid Tumor
What is being tested?
Fludarabine, Cyclophosphamide and IMA101 product
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
30 Jun 2017to 22 Sep 2021
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have pathologically confirmed advanced/metastatic cancer prior to enrollment.
  • HLA phenotype positive.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Life expectancy > 6 months prior to enrollment.
  • Patient is a candidate for a maximum of one further line of established therapy (prior to treatment with ACTolog).
  • The patient has adequate organ and marrow function per protocol
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  • At least one lesion (metastasis or primary tumor) being considered accessible by non-high-risk collection procedures for biopsy.
  • The patient has adequate hepatic function per protocol
  • The patient has serum creatinine clearance ≥50 mL/min by the Cockcroft-Gault formula.
  • The patient has adequate pulmonary function per protocol
  • Acceptable coagulation status
  • Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
  • Male subjects must agree to use effective contraception or abstinence while on study and for 90 days after infusion of the ACTolog T-cell product.
  • Ability of subject to understand and the willingness to sign written informed consent for study participation.
  • Confirmed availability of production capacities for the patient's ACTolog products.
  • ACTolog target expression as evaluated by the in vitro diagnostic device IMA_Detect: Patient's tumor must express at least one ACTolog target as assessed by quantitative PCR (qPCR) (to be assessed from a tumor biopsy to be performed if all other eligibility criteria are met).

Who cannot join

  • Any condition contraindicating leukapheresis.
  • Patients with brain metastases. 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.
  • HIV infection, active Hepatitis B or C infection, or active infections requiring oral or intravenous antibiotics or that can cause a severe disease and pose a severe danger to lab personnel working on patients' blood or tissue. If positive test results are not indicative of an active infection, patients can be included.
  • Treatment with excluded therapy per protocol
  • Previous extensive radiotherapy to the lung or liver during the last 4 months prior to lymphodepletion regimen.
  • The patient has cardiac conditions defined per protocol
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  • Patients with prior stem cell transplantation or solid organ transplantation.
  • The patient has concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
  • Active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation.
  • History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years.
  • The patient is pregnant or is breastfeeding.
  • Serious autoimmune disease per protocol
  • History of hypersensitivity to cyclophosphamide, fludarabine or IL-2.
  • Immunosuppression, not related to prior treatment for malignancy.
  • History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician.
  • Patients with Grade 3 or higher immune-related toxicities related to prior checkpoint inhibitors

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase I Adoptive Cellular Therapy Trial With Endogenous CD8+ T Cells (ACTolog® IMA101) Alone or in Combination With Atezolizumab in Patients With Relapsed and/or Refractory Solid Cancers

The study purpose is to learn about the safety and tolerability of IMA101 alone (Cohort 1) or in combination with atezolizumab (Cohort 2) in patients with advanced solid cancers that express pre-defined Immatics tumor targets.

Read the detailed description

SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) and the main biomarkers screening. If the patient is eligible, white blood cells will be collected with a leukapheresis for the manufacture of the IMA101 product.

MANUFACTURE: IMA101 product will be made from the patient's white blood cells.

TREATMENT: IMA101 product will be administered to the patient intravenously after lymphodepleting pre-conditioning with chemotherapy (fludarabine and cyclophosphamide).

Low-dose IL-2 will be self-administered twice daily for a total of 28 doses after infusion of IMA101 product. In Cohort 2, atezolizumab will be administered every 3 weeks, starting no earlier than 3 weeks after the IMA101 product infusion and after hematologic recovery.

Patients will be monitored closely throughout the study.

Conditions
Cancer, Solid Tumor
Being tested
Fludarabine, Cyclophosphamide, IMA101 product, Recombinant human interleukin-2, IMADetect
Keywords
Ovarian Cancer, Esophageal Cancer, Head and neck squamous cell carcinoma, non-small cell lung cancer, Gastric Cancer, T-cell Therapy, immunotherapy, adoptive cellular therapy, T-cell receptor, cell therapy, cytotherapy, IMA101, atezolizumab, Tecentriq
Medical subject headings
Neoplasms, Ovarian Neoplasms, Esophageal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms

What participants receive

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

  • FludarabineDrug

    Also called Fludarabine monophosphate

    Fludarabine infusion

  • CyclophosphamideDrug

    Also called Cytoxan

    Cyclophosphamide infusion

  • IMA101 productBiological

    i.v. infusion of IMA101 product(s).

  • Recombinant human interleukin-2Biological

    Also called Aldesleukin, Proleukin

    Low dose IL-2 Infusion for two weeks

  • IMADetectDiagnostic test

    IMADetect is a laboratory test that is part of screening used to determine the mRNA expression of ACTolog target source genes in tumor biopsies from solid tumors. IMADetect is intended for investigational use only.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab infusion will be given no earlier than 3 weeks post IMA101 infusion and after hematologic recovery is achieved, thereafter every 3 weeks until 1 year after IMA101 infusion.

Study groups in NCT02876510
Study groupRoleWhat they receive
IMA101 product only (Cohort 1)Experimental* Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide * Infusion of the IMA101 T-cell product(s) * Post-infusion administration of low-dose recombinant human interleukin-2
Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: IMA101 product; Biological: Recombinant human interleukin-2; Diagnostic Test: IMADetect
IMA101 product + atezolizumab (Cohort 2)Experimental* Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide * Infusion of the IMA101 T-cell product(s) * Post-infusion administration of low-dose recombinant human interleukin-2 * Treatment with atezolizumab every 3 weeks after IMA101 product infusion, for 1 year
Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: IMA101 product; Biological: Recombinant human interleukin-2; Diagnostic Test: IMADetect; Drug: Atezolizumab

What is being measured

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

  1. Incidence of adverse events (Safety and tolerability) of IMA101 alone or in combination with atezolizumab

    Measured: up to 18 months

Secondary outcomes (2)

  1. Peripheral T-cell persistence (assessment of frequency of T-cells over time)

    Measured: up to 18 months

  2. Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST)

    Measured: up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2016 (estimated)
  2. Study start30 Jun 2017
  3. Primary completion22 Sep 2021
  4. Study completion22 Sep 2021

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02876510
Sponsor's protocol ID
IMA101-101
Acronym
ACTolog
Status last verified
Feb 2025
First submitted
8 Aug 2016
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

  • Tsimberidou AM, Guenther K, Andersson BS, Mendrzyk R, Alpert A, Wagner C, Nowak A, Aslan K, Satelli A, Richter F, Kuttruff-Coqui S, Schoor O, Fritsche J, Coughlin Z, Mohamed AS, Sieger K, Norris B, Ort R, Beck J, Vo HH, Hoffgaard F, Ruh M, Backert L, Wistuba II, Fuhrmann D, Ibrahim NK, Morris VK, Kee BK, Halperin DM, Nogueras-Gonzalez GM, Kebriaei P, Shpall EJ, Vining D, Hwu P, Singh H, Reinhardt C, Britten CM, Hilf N, Weinschenk T, Maurer D, Walter S. Feasibility and Safety of Personalized, Multi-Target, Adoptive Cell Therapy (IMA101): First-in-Human Clinical Trial in Patients with Advanced Metastatic Cancer. Cancer Immunol Res. 2023 Jul 5;11(7):925-945. doi: 10.1158/2326-6066.CIR-22-0444.

    PubMed 37172100

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fludarabine, Cyclophosphamide and IMA101 product in people with Cancer and Solid Tumor, run by Immatics US, Inc. at 1 site in United States.

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 16 inclusion and 16 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 1 site in 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 (Safety and tolerability) of IMA101 alone or in combination with atezolizumab (time frame: up to 18 months). 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 NCT02876510, which also lists 2 linked publications.

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.

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ACTolog in Patients With Solid Cancers (NCT02876510) | AzTrials