ACTolog in Patients With Solid Cancers

NCT02876510 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: IMA101-101
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Solid Tumor

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

Outcome Measures

Primary Outcomes (1)

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

  up to 18 months

Secondary Outcomes (2)

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

  up to 18 months

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

  up to 18 months

Study Arms (2)

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

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

Drug: Fludarabine; Drug: Cyclophosphamide; Biological: IMA101 product; Biological: Recombinant human interleukin-2; Diagnostic Test: IMADetect; Drug: Atezolizumab

Interventions

Fludarabine DRUG

Fludarabine infusion

Also known as: Fludarabine monophosphate

IMA101 product + atezolizumab (Cohort 2); IMA101 product only (Cohort 1)

Cyclophosphamide DRUG

Cyclophosphamide infusion

Also known as: Cytoxan

IMA101 product + atezolizumab (Cohort 2); IMA101 product only (Cohort 1)

IMA101 product BIOLOGICAL

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

IMA101 product + atezolizumab (Cohort 2); IMA101 product only (Cohort 1)

Recombinant human interleukin-2 BIOLOGICAL

Low dose IL-2 Infusion for two weeks

Also known as: Aldesleukin, Proleukin

IMA101 product + atezolizumab (Cohort 2); IMA101 product only (Cohort 1)

IMADetect DIAGNOSTIC_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.

IMA101 product + atezolizumab (Cohort 2); IMA101 product only (Cohort 1)

Atezolizumab DRUG

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.

Also known as: Tecentriq

IMA101 product + atezolizumab (Cohort 2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Immatics US, Inc.: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 37172100 DERIVED

• 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.

  PMID: 29505699 DERIVED

MeSH Terms

Conditions

Neoplasms; Ovarian Neoplasms; Esophageal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms

Interventions

fludarabine; fludarabine phosphate; Cyclophosphamide; aldesleukin; atezolizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Cedrik Britten, M.D.

  Immatics US, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 23, 2016
• Study Start: June 30, 2017
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)