Clinical trial • Phase II • Oncology

Autologous tumour-infiltrating lymphocytes for Metastatic non-small cell lung cancer

Phase II trial of Autologous tumour-infiltrating lymphocytes for Metastatic non-small cell lung cancer. None/Not specified-controlled. 110 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic non-small cell lung cancer
Trial Stage
Phase II
Drug Modality
Cell therapy | Small molecule | Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
28-02-2024
First CTIS Authorization Date
25-03-2024

Trial design

None/Not specified-controlled Phase II trial in Belgium, Netherlands, Germany and others.

Comparator
None/Not specified
Target Sample Size
110

Eligibility

Recruits 110 The trial metadata indicates isVulnerablePopulationSelected = true. All participants must "Provide written informed consent and written authorization for use and disclosure of protected health information." Consent is provided by the participant (adults only, age 18+). Country-specific subject information and informed consent forms (ICFs) are provided (documents in English, Dutch, French, German, Italian, Spanish are available in the public documents list). No assent process for minors is described (trial inclusion requires age ≥18)..

Pregnancy Exclusion
6.Are pregnant or breastfeeding. Female patients of childbearing potential must have a negative beta-human chorionic gonadotropin (βHCG) test with minimum sensitivity of 25 IU/L β-HCG (or equivalent) at Screening.
Vulnerable Population
The trial metadata indicates isVulnerablePopulationSelected = true. All participants must "Provide written informed consent and written authorization for use and disclosure of protected health information." Consent is provided by the participant (adults only, age 18+). Country-specific subject information and informed consent forms (ICFs) are provided (documents in English, Dutch, French, German, Italian, Spanish are available in the public documents list). No assent process for minors is described (trial inclusion requires age ≥18).

Inclusion criteria

  • {"criterion_text":"- 1. Provide written informed consent and written authorization for use and disclosure of protected health information."}
  • {"criterion_text":"- 10. Have a left ventricular ejection fraction (LVEF) >45% and be New York Heart Association (NYHA) Class 1."}
  • {"criterion_text":"- 11. Have adequate pulmonary function. All patients must perform a 6-minute walk test and must be able to walk a distance of at least 80% of predicted for age and sex with no evidence of hypoxia (ie, saturation of peripheral oxygen [SpO2] must remain ≥90% on room air)."}
  • {"criterion_text":"- 12. Have completed/discontinued chemotherapy ≥21 days prior to tumor harvest."}
  • {"criterion_text":"- 13. Must have recovered from all prior anticancer treatment-related adverse events to Grade≤1 (per CTCAE v5.0). Patients with irreversible toxicity (eg, alopecia, vitiligo) after prior anticancer therapies that are not considered by the Investigator to be a likely safety risk may qualify for the study after discussion with the Medical Monitor"}
  • {"criterion_text":"- 14. Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method ofhighly effective birth control during treatment and for 12 months after receiving all protocol-related therapy."}
  • {"criterion_text":"- 2. Be 18 to 70 years of age at the time of signing of informed consent form. Patients who are >70 years of age may be allowed to enroll after discussion with the Medical Monitor and with consideration of factors including but not limited to performance status, life expectancy, and frailty of the patient."}
  • {"criterion_text":"- 3. Have histologically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC (squamous, nonsquamous, adenocarcinoma, large cell,or mixed histologies) without EGFR, ALK, or ROSI genomic alterations."}
  • {"criterion_text":"- 4. Meet prior therapy criteria: -post-progression tumor harvest: Patient must have documented radiographic disease progression on or after the first-line therapy, inclusive of prior ICI and platinum-based chemotherapy ± bevacizumab or health authority approved targeted therapy. -pre-progression tumor harvest and TIL production: Patient must have residual resectable disease after completion of the platinum-based chemotherapy component of either concurrent or sequential ICI and platinum-based chemotherapy, meet all eligibility criteria except documented disease progression, and intend to receive TIL therapy after disease progression on current therapy"}
  • {"criterion_text":"- 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of >6 months, in the Investigator's opinion."}
  • {"criterion_text":"- 6. Cohorts 1, 2 and 4: Have at least 1 resectable lesion (or aggregate lesions) with an expected minimum 1.5 cm short axis diameter for TIL production. Cohort 3: Have a single, measurable lesion (RECIST v1.1) and/or are unable to undergo a surgical tumor resection, but able to undergo tumor harvest for TIL generation via image-guided core biopsy. Retreatment Cohort: Meet any tumor requirement listed above. All Cohorts: If the lesion considered for harvest is within a previously irradiated field, the lesion must have demonstratedradiographic progression prior to harvest, and the irradiation must have been completed at least 3 months prior to enrollment. Patients must have an adequate histopathology specimen for protocol-required testing."}
  • {"criterion_text":"- 7. Have at least 1 remaining measurable lesion as defined by RECIST v1.1 following tumor harvest for TIL manufacturing that is documented at Screening"}
  • {"criterion_text":"- 8. Required hematologic parameters: •Absolute neutrophil count ≥1000/mm3. •Hemoglobin ≥8.0 g/dL. •Platelet count ≥100,000/mm3"}
  • {"criterion_text":"- 9. Have adequate organ function with the following laboratory test values: •ALT and AST ≤3times the upper limit of normal (≤3 × ULN); for patients with liver metastases ≤5 × ULN. •Total bilirubin ≤2 mg/dL; patients with Gilbert's Syndrome ≤3mg/dL. •Estimated creatinine clearance ≥40 mL/min using the Cockcroft-Gault formula at Screening"}

Exclusion criteria

  • {"criterion_text":"- 1.Have a history of allogeneic organ transplant or any form of cell therapy involving a prior nonmyeloablative or myeloablative chemotherapy regimen within the past 20 years. Patients being retreated with LN-145 are not excluded due to prior NMA-LD during this study."}
  • {"criterion_text":"- 10.Have a history of hypersensitivity to any component of the study drugs. LN-145 should not be administered to patients with a known hypersensitivity to any component of the autologous TIL product formulation, including, but not limited to, any of the following: •NMA-LD (cyclophosphamide, mesna, and fludarabine) •Proleukin®, aldesleukin, IL-2 •Antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin). These patients may be eligible if current hypersensitivity has been excluded. •Any component of the TIL product formulation, including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, or dextran-40"}
  • {"criterion_text":"- 11.Have had another primary malignancy within the previous 3 years (except for malignancies that do not require treatment or have been curatively treated >1 year ago, and in the judgment of the Investigator do not pose a significant risk of recurrence including, but not limited to: in situ carcinoma of the cervix; early stage skin cancer, including nonmelanoma skin cancer; ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of the breast; prostate cancer with Gleason score ≤6; or superficial bladder cancer)."}
  • {"criterion_text":"- 12.Participated in another clinical study with an investigational product within 21 days prior to enrollment with the exception of investigational programmed cell death-1 (PD-1)/PD-L1 inhibitors or tyrosine kinase inhibitors (TKIs), which may be continued until 7 days prior to initiation of NMA-LD"}
  • {"criterion_text":"- 13.Have any condition or characteristic (eg, known psychiatric diagnosis/symptoms, alcohol abuse, or substance abuse) that, in the opinion of the Investigator, could interfere with the evaluation or interpretation of study treatment, patient safety, or study results"}
  • {"criterion_text":"- 2.Have known actionable EGFR, ALK, or ROSI driver mutations."}
  • {"criterion_text":"- 3.Have symptomatic untreated brain metastasis. Patients with brain metastases may be enrolled with the following considerations and only after discussion with the Medical Monitor:"}
  • {"criterion_text":"- 4.Require systemic steroid therapy >10 mg/day prednisone or equivalent. Patients receiving steroids as replacement therapy for adrenocortical insufficiency at ≤10 mg/day prednisone or equivalent are not excluded."}
  • {"criterion_text":"- 5.Have evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment or as per required screening tests 6.Are pregnant or breastfeeding. Female patients of childbearing potential must have a negative beta-human chorionic gonadotropin (βHCG) test with minimum sensitivity of 25 IU/L β-HCG (or equivalent) at Screening."}
  • {"criterion_text":"- 6.Are pregnant or breastfeeding. Female patients of childbearing potential must have a negative beta-human chorionic gonadotropin (βHCG) test with minimum sensitivity of 25 IU/L β-HCG (or equivalent) at Screening."}
  • {"criterion_text":"- 7.Have an active medical illness(es) that in the opinion of the Investigator would pose increased risks for study participation, such as systemic infections, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune systems."}
  • {"criterion_text":"- 8.Have received a live or attenuated vaccination within 28 days prior to the start of NMA-LD."}
  • {"criterion_text":"- 9.Have any form of primary immunodeficiency (eg, severe combined immunodeficiency disease [SCID] or acquired immune deficiency syndrome [AIDS])."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- ORR is defined as the proportion of patients who have a confirmed CR or PR as assessed per RECIST v1.1 by the IRC (Cohorts 1 and 2) or by the Investigator (Cohorts 3, 4 and Retreatment Cohort) from the date of LN145 infusion until disease progression or start of a new anticancer therapy.","definition_or_measurement_approach":"ORR measured as proportion of patients with confirmed complete response (CR) or partial response (PR) assessed per RECIST v1.1 by IRC for Cohorts 1 and 2 and by Investigator for Cohorts 3, 4 and Retreatment Cohort, measured from date of LN-145 infusion until disease progression or start of new anticancer therapy."}

Secondary endpoints

  • {"endpoint_text":"- •ORR (Cohorts 1 and 2), CR rate, DOR, DCR, and PFS (all cohorts) as assessed by the Investigator per RECIST v1.1","definition_or_measurement_approach":"Assessed by Investigator per RECIST v1.1 for specified cohorts; includes ORR, CR rate, duration of response (DOR), disease control rate (DCR), progression-free survival (PFS)."}
  • {"endpoint_text":"- • CR rate, DOR, DCR, and PFS as assessed by IRC per RECIST v1.1 (Cohorts 1 and 2)","definition_or_measurement_approach":"Assessed by Independent Review Committee (IRC) per RECIST v1.1 for Cohorts 1 and 2; includes complete response rate, DOR, DCR, and PFS."}
  • {"endpoint_text":"- • Overall survival (OS)","definition_or_measurement_approach":"Overall survival (OS) listed as a secondary endpoint; specific measurement timepoints/method not further specified in the provided data."}
  • {"endpoint_text":"- • Incidence of Grade ≥3 TEAEs and SAEs per CTCAE v5.0 in all patients","definition_or_measurement_approach":"Safety assessed by incidence of Grade ≥3 treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded per CTCAE v5.0."}
  • {"endpoint_text":"- • Percentage of successful LN-145 product generated from core biopsies in Cohort 3","definition_or_measurement_approach":"Measured as percentage of successful LN-145 product generation from image-guided core biopsies in Cohort 3."}

Recruitment

Planned Sample Size
110
Recruitment Window Months
67
Consent Approach
Written informed consent required from each participant: inclusion criterion 1 states participants must "Provide written informed consent and written authorization for use and disclosure of protected health information." Subject information and informed consent forms (ICFs) are provided as country-specific documents; available public ICF files include multiple languages (English, Dutch, French, German, Italian, Spanish) and country-specific versions. Participants are adults (≥18); no assent for minors is described.

Methods

  • Recruitment arrangements documents are provided per country (files: Recruitment Arrangements for BE, IT, NL, DE, ES, FR) but detailed channels/content not available in the provided JSON.
  • Referral / GP letter templates exist for Italy (file: K2_IOV-LUN-202_GP_Letter_IT_Italian_Public) and a Referral-Email-Template for Germany (file: K2_IOV-LUN-202_Refferal-EMail-Template_DE_German_Public) — indicating use of physician referral and GP outreach in those countries.
  • Recruitment-related addendum and referral templates (Germany) indicate email/referral methods (content not included).
  • Sponsor/third-party activity: Scout Clinical noted responsibility for subject reimbursement in Belgium, France, and Spain (suggesting local site support for recruitment logistics).
  • Sites were notified of a temporary pause in identification and screening of new potential participants for scheduled maintenance (sponsor communication; effective 11-11-2025).

Geography

Total Number Of Sites
42
Total Number Of Participants
115

Belgium

Earliest CTIS Part Ii Submission Date
09-05-2025
Latest Decision Or Authorization Date
04-11-2025
Processing Time Days
179
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
UZ Brussel
Department Name
Universitair Ziekenhuis Brussel Medische Oncologie
Contact Person Name
Lore Decoster
Contact Person Email
Lore.decoster@uzbrussel.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Service d’Oncologie Médicale
Contact Person Name
Charles Pottier
Contact Person Email
Charles.pottier@chuliege.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Universitair Ziekenhuis Antwerpen Dienst Oncologie
Contact Person Name
Jo Raskin
Contact Person Email
Jo.raskin@uza.be

Netherlands

Earliest CTIS Part Ii Submission Date
12-02-2024
Latest Decision Or Authorization Date
03-11-2025
Processing Time Days
630
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Medical Oncology
Contact Person Name
John Haanen
Contact Person Email
j.haanen@nki.nl

Germany

Earliest CTIS Part Ii Submission Date
12-02-2024
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
653
Number Of Sites
7
Number Of Participants
30

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. med, Klinik Innere Medizin Onkologisches Zentrum
Contact Person Name
Maximilian Christopeit
Contact Person Email
m.christopeit@uke.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik III, Innere Medizin mit den Schwerpunkten Onkologie, Hämatologie
Contact Person Name
Peter Brossart
Contact Person Email
peter.brossart@ukbonn.de
Site Name
Universitat Heidelberg (Mannheim)
Department Name
Abteilung Personalisierte Onkologie mit Schwerpunkt Bronchialkarzinom
Contact Person Name
Sonja Loges
Contact Person Email
studien.personko@umm.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Med. Klinik V / Thorakale Onkologie
Contact Person Name
Amanda Tufman
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik II, Hämatologie/Onkologie, Rheumatologie, Infektiologie, HIV
Contact Person Name
Martin Sebastian
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
ECTU Campus Benjamin Franklin Medizinische Klinik mit dem Schwerpunkt Hämatologie und Onkologie
Contact Person Name
Antonia Busse
Contact Person Email
antonia.busse@charite.de
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I / ECTU (Early Clinical Trial Unit), Haus 27, 4. Etage
Contact Person Name
Martin Wermke

Italy

Earliest CTIS Part Ii Submission Date
15-05-2025
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
176
Number Of Sites
7
Number Of Participants
10

Sites

Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
SOD Radioterapia Oncologica
Contact Person Name
Lorenzo Livi
Contact Person Email
lorenzo.livi@unifi.it
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Oncology
Contact Person Name
Vanesa Gregorc
Contact Person Email
Vanesa.gregorc@ircc.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UOC Oncologia Medica
Contact Person Name
Roberto Ferrara
Contact Person Email
ferrara.roberto@hsr.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S.C. Oncologia Medica 1
Contact Person Name
Arsela Prelaj
Site Name
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Department Name
UOC Oncologia
Contact Person Name
Rita Chiari
Contact Person Email
rita.chiari@sanita.marche.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Oncology and Hematology
Contact Person Name
Annalisa Fontana
Contact Person Email
fontana.annalisa@aou.mo.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC Oncologia
Contact Person Name
Franscesco Agustoni
Contact Person Email
f.agustoni@smatteo.pv.it

Spain

Earliest CTIS Part Ii Submission Date
14-05-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
299
Number Of Sites
15
Number Of Participants
20

Sites

Site Name
Hospital Universitario Regional De Malaga
Department Name
Servicio de Oncologia medica
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Oncologia médica
Contact Person Name
Aranzazu Manzano Fernandez
Contact Person Email
lpazaresr@seom.org
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Servicio de Oncologia medica
Contact Person Name
Pilar Garrido Lopez
Contact Person Email
pilargarridol@gmail.com
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Servicio de Oncologia médica
Contact Person Name
Paula Espinosa Olarte
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio de Oncologia
Contact Person Name
María de los Reyes Bernabe Caro
Contact Person Email
bernabeensayos@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de Oncologia
Contact Person Name
Laura Angelats Company
Contact Person Email
langelats@recerca.clinic.cat
Site Name
Hospital Universitario Reina Sofia
Department Name
Servicio de Oncologia medica
Contact Person Name
Isidoro Carlos Barneto Aranda
Contact Person Email
isidoroc.barneto@gmail.com
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Servicio de Oncologia
Contact Person Name
Miguel Fenandez de Sanmamed
Contact Person Email
msanmamed@unav.es
Site Name
Instituto Oncologico Dr. Rosell S.L.
Department Name
Servicio de Oncologia medica
Contact Person Name
María González Cao
Contact Person Email
mgonzalezcao@oncorosell.com
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Servicio de Oncologia médica
Contact Person Name
Gema Garcia Ledo
Contact Person Email
gmgarcialedo@hmhospitales.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Servicio de Oncologia médica
Contact Person Name
Valentina Gambardella
Contact Person Email
valen.gambardella@gmail.com
Site Name
Hospital Universitario De Salamanca
Department Name
Servicio de Oncologia médica
Contact Person Name
Edel del Barco Morillo
Contact Person Email
ebarco@saludcastillayleon.es
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Servicio de Oncologia
Contact Person Name
Miguel Fenandez de Sanmamed
Contact Person Email
msanmamed@unav.es
Site Name
Hospital Universitario La Paz
Department Name
Servicio de Oncologia medica
Contact Person Name
Francisco Javier de Castro
Site Name
Instituto Oncologico Dr. Rosell / additional Spanish sites
Department Name
Servicio de Oncologia médica

France

Earliest CTIS Part Ii Submission Date
02-05-2025
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
340
Number Of Sites
9
Number Of Participants
12

Sites

Site Name
Hospices Civils De Lyon
Department Name
Service de Pneumologie
Contact Person Name
Sébastien COURAUD
Contact Person Email
sebastien.couraud@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Départment d’oncologie médicale Pôle régional de Cancérologie
Contact Person Name
Nicolas Isambert
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Département d’Oncologie Médicale
Contact Person Name
Aline Houessinon
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Département de Pneumologie, Oncologie Thoracique et Soins Intensifs Respiratoires
Contact Person Name
Jonathan Benzaquen
Contact Person Email
Benzaquen.j@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Département d’Oncologie médicale – Unité d’oncologie thoracique
Contact Person Name
Elvire PONS-TOSTIVINT
Contact Person Email
Elvire.pons@chu-nantes.fr
Site Name
Institut Paoli Calmettes
Contact Person Name
Philippe Rochigneux
Contact Person Email
rochigneuxp@ipc.unicancer.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Département d’oncologie médicale
Contact Person Name
Romane Muletier
Site Name
Institut Gustave Roussy
Department Name
Département d’Oncologie Médicalee
Contact Person Name
Benjamin Besse
Site Name
CHRU De Nancy
Department Name
Département de Pneumologie
Contact Person Name
Bertrand Mennecier
Contact Person Email
b.mennecier@chru-nancy.fr

Sponsor

Primary sponsor

Full Name
Iovance Biotherapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
Support with CTIS system; Clinical Management, Medical Monitoring (EMEA); other duties (codes 1,12,15,5 as listed).
Name
Perceptive Informatics Inc.
Responsibilities
Central storage of radiology scans.
Name
Theradex (Europe) Limited
Responsibilities
Duties listed in sponsor declarations (codes 6,7).
Name
Syneos Health UK Limited
Responsibilities
Duties listed in sponsor declarations (code 8).
Name
Scout Clinical
Responsibilities
Subject reimbursement for Belgium, France, and Spain.
Name
Mlm Medical Labs GmbH
Responsibilities
Duties listed in sponsor declarations (code 4).

Third parties

  • {"country":"Germany","full_name":"Mlm Medical Labs GmbH","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Theradex (Europe) Limited","duties_or_roles":"[{\"code\":\"6\"},{\"code\":\"7\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"[{\"code\":\"1\"},{\"code\":\"12\"},{\"code\":\"15\",\"value\":\"Support with CTIS system; Clinical Management, Medical Monitoring (EMEA)\"},{\"code\":\"5\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Central storage of radiology scans\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Subject reimbursement for Belgium, France, and Spain.\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom","full_name":"Syneos Health UK Limited","duties_or_roles":"[{\"code\":\"8\"}]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
LN-145
Active Substance
Autologous tumour-infiltrating lymphocytes
Modality
Cell therapy
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
1
Maximum Dose
100000000000 DF dosage form
Investigational Product Name
Endoxan / Cyclophosphamide (various marketed presentations listed)
Active Substance
Cyclophosphamide monohydrate / Cyclophosphamide
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
60 mg/kg (max daily dose amount per product entries)
Investigational Product Name
Fludarabine (various marketed presentations listed)
Active Substance
Fludarabine phosphate
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
25 mg/m2 (max daily dose amount per product entries)
Investigational Product Name
Proleukin / Aldesleukin (IL-2)
Active Substance
Aldesleukin
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
600000 IU/kg (max daily dose amount per product entries)
Combination Treatment
Yes

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