Clinical trial · Interventional
ACTolog in Patients With Solid Cancers
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
NCT02876510CI-TRIAL-00085482ACTologcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| IMA101 product | Biological | — | UNRESOLVED |
| IMADetect | Diagnostic Test | — | UNRESOLVED |
| Recombinant human interleukin-2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IMA101 product only (Cohort 1)
- description
- * 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
- interventionNames
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Biological: IMA101 product
- Biological: Recombinant human interleukin-2
- Diagnostic Test: IMADetect
- type
- EXPERIMENTAL
- label
- IMA101 product + atezolizumab (Cohort 2)
- description
- * 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
- interventionNames
- Drug: Fludarabine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDTsimberidou 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
- DERIVEDFritsche 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