Authorised Phase I and Phase II (Integrated)- First administration to humans Pancreatic Ductal Adenocarcinoma

Master protocol of TCR-modified T cell therapy targeting HLA-restricted KRAS antigen administered in adult patients with metastatic or locally advanced PDAC

EU CTIS ID: 2024-513900-32-00

What this study is testing

Phase 1: - To assess safety and tolerability of ANOC-001, ANOC-002 and ANOC-003 in participants who are HLA and KRAS mutation status matched to the specific TCR-T product in positive metastatic or locally advanced PDAC Phase 2: - To further assess safety and tolerability of RP2D of ANOC-001, ANOC-002 and ANOC-003 in participants with metastatic or locally advanced PDAC

Phase I and Phase II (Integrated)- First administration to humans

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Pre-screening: Adult participants (18 years or older) with newly diagnosed metastatic PDAC or locally advanced PDAC disease.
18. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): ECOG performance status of <=1 or Karnofsky performance status >=70%.
19. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Renal: Creatinine clearance >=50 mL/min by chronic kidney disease epidemiology collaboration (CKD-EPI) or 24-hour urine clearance.
6. Leukapheresis: Redacted
20. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Hepatic: Total bilirubin <2.0 mg/dL
7. Leukapheresis: Redacted

You likely can't join if

1. Another malignancy other than PDAC. Participants with concomitant second malignancies (except adequately treated no melanomatous skin cancers, carcinoma in situ of the breast, treated superficial bladder cancer or prostate cancer, or in situ cervical cancers) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period. Long-term adjuvant therapy example: breast cancer is acceptable.
4. Current or history of brain metastasis.
5. Currently receiving other investigational medicinal products
6. Participants with known genetic status for whom other treatments are available e.g. BRCA, MSI-H.
7. Women who are pregnant or breastfeeding.
8. Participants with any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease [SCID] or human immunodeficiency virus (HIV).

See the full eligibility criteria

Who can join

1. Pre-screening: Adult participants (18 years or older) with newly diagnosed metastatic PDAC or locally advanced PDAC disease.
18. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): ECOG performance status of <=1 or Karnofsky performance status >=70%.
19. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Renal: Creatinine clearance >=50 mL/min by chronic kidney disease epidemiology collaboration (CKD-EPI) or 24-hour urine clearance.
6. Leukapheresis: Redacted
20. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Hepatic: Total bilirubin <2.0 mg/dL
7. Leukapheresis: Redacted
8. Leukapheresis: Redacted
9. Leukapheresis: Adequate venous access suitable for leukapheresis.
14. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Redacted
15. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Measurable disease by RECIST 1.1 criteria at the time of first line treatment. Baseline imaging (for example, diagnostic computed tomography (CT) chest/abdomen/pelvis and imaging of the affected extremity or brain, as appropriate), magnetic resonance imaging (MRI) or CT scan) must be obtained before the first planned T cell infusion. CT can be substituted for MRI in participants who are unable to have CT contrast.
16. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Participants must be at 2-3 weeks from last systemic treatment; 2-3 weeks must have passed since any: immunotherapy (for example, T-cell infusions, immunomodulatory agents, interleukins, vaccines), small molecule or chemotherapy cancer treatment, other investigational agents. If a resolution of any residual toxicity of Grade <=1 occurs before 2-3 weeks, participants can start the treatment at the PI discretion.
10. Leukapheresis: Fertile male and female participants must use a highly effective contraceptive method before, during, and after the last mutKRAS TCR infusion, per timelines defined in Protocol. Acceptable contraception for women includes implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence, or a partner who has been vasectomized for at least 6 months. Acceptable contraception for male includes having had a vasectomy for at least 6 months, sexual abstinence, condom plus spermicide. Fertile female and male participants must adhere to any treatment-specific pregnancy prevention guidelines.
17. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): There is no washout period for radiation, so long as radiated lesion is not the lesion being evaluated for RECIST measurements on the protocol. Bisphosphonates are permitted.
21. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <5x upper limit of normal (ULN).
22. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Participants with suspected hyperbilirubinemia may be included if total bilirubin >3 mg/dl but no other evidence of hepatic dysfunction.
23. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Hematologic: Absolute neutrophil count (ANC) >=1000 cells/ mm3
24. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Nutrition: Albumin >=3 g/dL
25. Inclusion Criteria for Start of Treatment with IMP (intention-to- treat group [ITT]): Avoid using granulocyte-macrophage colony-stimulating factor (GM-CSF) supportive therapy within 72 hours of sample collection.
11. Leukapheresis: 18 years or older at the time of enrolment.
12. Leukapheresis: Capable of understanding and providing a written informed consent.
13. Leukapheresis: Eastern Cooperative Oncology Group (ECOG) performance status of <=1 or Karnofsky performance status >=70% (no uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated uncontrolled pleural drainage more than once every 28 days).
2. Pre-screening: Capable of understanding and willing to sign a written informed consent
3. Pre-screening: Participants must be willing and able to comply with all study-related procedures and follow-up requirements.
4. Leukapheresis: Diagnosis of metastatic PDAC or locally advanced PDAC.
5. Leukapheresis: Confirmation of PDAC diagnosis.

What rules you out

1. Another malignancy other than PDAC. Participants with concomitant second malignancies (except adequately treated no melanomatous skin cancers, carcinoma in situ of the breast, treated superficial bladder cancer or prostate cancer, or in situ cervical cancers) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period. Long-term adjuvant therapy example: breast cancer is acceptable.
4. Current or history of brain metastasis.
5. Currently receiving other investigational medicinal products
6. Participants with known genetic status for whom other treatments are available e.g. BRCA, MSI-H.
7. Women who are pregnant or breastfeeding.
8. Participants with any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease [SCID] or human immunodeficiency virus (HIV).
9. Participants with active systemic infections, coagulation disorders, or any other major medical illnesses e.g. Hepatitis B or C.
16. Current or past employees, or any of their immediate family members (spouse, parent, child, sibling) or members of their household, of the Sponsor, Contract Research Organization (CRO) or Clinical Trial Site who were/are directly involved in the study design, conduct, or analysis.
10. Participants with concurrent opportunistic infections.
11. Participants on concurrent systemic steroid therapy.
12. Participants with a history of severe immediate hypersensitivity reaction to any of the medicines used in this study (e.g., cyclophosphamide, fludarabine).
13. Participants with active coronary ischaemic symptoms.
14. Redacted
15. Current treatment on another therapeutic clinical trial. Supportive care trials or non-treatment trials e.g., participant reported outcomes (PRO) methods studies, are allowed.
2. Redacted
3. Resectable PDAC disease

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.