CompletedPhase 1NCT02876510
Official study title

ACTolog in Patients With Solid Cancers

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedFludarabine and Cyclophosphamide

Plus 4 other study approaches.

Who it may be forCancer · Solid Tumor

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 4, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Immatics US, Inc.

Study sponsor

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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Immatics US, Inc.
Interventions being studied
Drug: Fludarabine; Drug: Cyclophosphamide; Biological: IMA101 product; Biological: Recombinant human interleukin-2; Diagnostic Test: IMADetect; Drug: Atezolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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).

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 4, 2025. Always confirm current availability with the study team.

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