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ACTolog in Patients With Solid Cancers (ACTolog)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02876510
Recruitment Status : Active, not recruiting
First Posted : August 23, 2016
Last Update Posted : August 14, 2020
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Immatics US, Inc.

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.

Condition or disease Intervention/treatment Phase
Cancer Solid Tumor Drug: Fludarabine Drug: Cyclophosphamide Biological: IMA101 product Biological: Recombinant human interleukin-2 Diagnostic Test: IMADetect Drug: Atezolizumab Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: IMA101 product only (Cohort 1)
  • 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
Fludarabine infusion
Other Name: Fludarabine monophosphate

Drug: Cyclophosphamide
Cyclophosphamide infusion
Other Name: Cytoxan

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

Biological: Recombinant human interleukin-2
Low dose IL-2 Infusion for two weeks
Other Names:
  • Aldesleukin
  • Proleukin

Diagnostic Test: IMADetect
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.

Experimental: IMA101 product + atezolizumab (Cohort 2)
  • 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
Fludarabine infusion
Other Name: Fludarabine monophosphate

Drug: Cyclophosphamide
Cyclophosphamide infusion
Other Name: Cytoxan

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

Biological: Recombinant human interleukin-2
Low dose IL-2 Infusion for two weeks
Other Names:
  • Aldesleukin
  • Proleukin

Diagnostic Test: IMADetect
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.

Drug: Atezolizumab
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.
Other Name: Tecentriq




Primary Outcome Measures :
  1. Incidence of adverse events (Safety and tolerability) of IMA101 alone or in combination with atezolizumab [ Time Frame: up to 18 months ]

Secondary Outcome Measures :
  1. Peripheral T-cell persistence (assessment of frequency of T-cells over time) [ Time Frame: up to 18 months ]
  2. Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST) [ Time Frame: up to 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have pathologically confirmed advanced/metastatic cancer prior to enrollment.
  2. HLA phenotype positive.
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  4. Life expectancy > 6 months prior to enrollment.
  5. Patient is a candidate for a maximum of one further line of established therapy (prior to treatment with ACTolog).
  6. The patient has adequate organ and marrow function per protocol
  7. At least one lesion (metastasis or primary tumor) being considered accessible by non-high-risk collection procedures for biopsy.
  8. The patient has adequate hepatic function per protocol
  9. The patient has serum creatinine clearance ≥50 mL/min by the Cockcroft-Gault formula.
  10. The patient has adequate pulmonary function per protocol
  11. Acceptable coagulation status
  12. 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.
  13. 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.
  14. Ability of subject to understand and the willingness to sign written informed consent for study participation.
  15. Confirmed availability of production capacities for the patient's ACTolog products.
  16. 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).

Exclusion Criteria

  1. Any condition contraindicating leukapheresis.
  2. 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.
  3. 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.
  4. Treatment with excluded therapy per protocol
  5. Previous extensive radiotherapy to the lung or liver during the last 4 months prior to lymphodepletion regimen.
  6. The patient has cardiac conditions defined per protocol
  7. Patients with prior stem cell transplantation or solid organ transplantation.
  8. The patient has concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
  9. Active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation.
  10. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years.
  11. The patient is pregnant or is breastfeeding.
  12. Serious autoimmune disease per protocol
  13. History of hypersensitivity to cyclophosphamide, fludarabine or IL-2.
  14. Immunosuppression, not related to prior treatment for malignancy.
  15. History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician.
  16. Patients with Grade 3 or higher immune-related toxicities related to prior checkpoint inhibitors

Information from the National Library of Medicine

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): NCT02876510


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Immatics US, Inc.
M.D. Anderson Cancer Center
Investigators
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Study Director: Cedrik Britten, M.D. Immatics US, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Immatics US, Inc.
ClinicalTrials.gov Identifier: NCT02876510    
Other Study ID Numbers: IMA101-101
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Immatics US, Inc.:
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
Additional relevant MeSH terms:
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Vidarabine
Aldesleukin
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Atezolizumab
Interleukin-2
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents