Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-01-01 @ 1:49 PM
Study NCT ID:
NCT06051695
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2023-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 474}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2023-09-18', 'studyFirstSubmitQcDate': '2023-09-21', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Rate of adverse events and dose limiting toxicities (DLTs) by dose level', 'timeFrame': 'From the time of Informed consent until 24 months (2 years) post infusion', 'description': 'Adverse Events and toxicity will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version (CTCAE) 5.0 (or current version). Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) events will be graded according to the criteria described in the current protocol.'}, {'measure': 'Phase 1: Recommended Phase 2 Dose (RP2D)', 'timeFrame': '21 days post infusion', 'description': 'The RP2D will be identified utilizing a BOIN study design in addition to considering safety and biomarker analysis.'}, {'measure': 'Phase 2: The Overall Response Rate (ORR) for patients', 'timeFrame': '24 months post infusion', 'description': 'The ORR will be evaluated per RECIST v1.1 and assessed by independent central review.'}], 'secondaryOutcomes': [{'measure': 'Persistence of Tmod product', 'timeFrame': 'up to 24 months post infusion', 'description': 'Number of Tmod CAR T cells present as assessed by polymerase chain reaction (PCR) (or similar method) on participant blood samples'}, {'measure': 'Cytokine analysis', 'timeFrame': 'up to 24 months post infusion', 'description': 'Cytokine levels such as interferon-gamma (IFN-γ) and interleukin-6 (IL-6) assessed by cytokine analysis on participant blood samples'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['CAR T Cell', 'Solid Tumors', 'Autologous', 'T Cell', 'Mesothelin', 'MSLN', 'HLA-A2', 'Solid Tumors expressing MSLN', 'Pancreatic', 'Cell Therapy', 'Gene Therapy', 'blocker', 'Cancer', 'PANC', 'CRC', 'Colorectal Cancer', 'Lung Cancer', 'NSCLC', 'OVCA', 'MESOM', 'Ovarian Cancer', 'Mesothelioma', 'Logic-gate'], 'conditions': ['Solid Tumor, Adult', 'Colorectal Cancer', 'NSCLC', 'Non Small Cell Lung Cancer', 'NSCLC, Recurrent', 'Non-Small Cell Squamous Lung Cancer', 'Pancreas Cancer', 'Pancreatic Neoplasm', 'Colorectal Adenocarcinoma', 'CRC', 'Colon Cancer', 'Rectal Cancer', 'Cancer', 'Ovarian Cancer', 'Ovarian Neoplasms', 'Mesothelioma', 'Mesothelioma, Malignant', 'Ovary Cancer', 'Lung Cancer', 'MESOM']}, 'referencesModule': {'references': [{'pmid': '33012527', 'type': 'BACKGROUND', 'citation': 'Hamburger AE, DiAndreth B, Cui J, Daris ME, Munguia ML, Deshmukh K, Mock JY, Asuelime GE, Lim ED, Kreke MR, Tokatlian T, Kamb A. Engineered T cells directed at tumors with defined allelic loss. Mol Immunol. 2020 Dec;128:298-310. doi: 10.1016/j.molimm.2020.09.012. Epub 2020 Oct 1.'}, {'pmid': '33731480', 'type': 'BACKGROUND', 'citation': 'Hwang MS, Mog BJ, Douglass J, Pearlman AH, Hsiue EH, Paul S, DiNapoli SR, Konig MF, Pardoll DM, Gabelli SB, Bettegowda C, Papadopoulos N, Vogelstein B, Zhou S, Kinzler KW. Targeting loss of heterozygosity for cancer-specific immunotherapy. Proc Natl Acad Sci U S A. 2021 Mar 23;118(12):e2022410118. doi: 10.1073/pnas.2022410118.'}, {'pmid': '20164920', 'type': 'BACKGROUND', 'citation': 'Beroukhim R, Mermel CH, Porter D, Wei G, Raychaudhuri S, Donovan J, Barretina J, Boehm JS, Dobson J, Urashima M, Mc Henry KT, Pinchback RM, Ligon AH, Cho YJ, Haery L, Greulich H, Reich M, Winckler W, Lawrence MS, Weir BA, Tanaka KE, Chiang DY, Bass AJ, Loo A, Hoffman C, Prensner J, Liefeld T, Gao Q, Yecies D, Signoretti S, Maher E, Kaye FJ, Sasaki H, Tepper JE, Fletcher JA, Tabernero J, Baselga J, Tsao MS, Demichelis F, Rubin MA, Janne PA, Daly MJ, Nucera C, Levine RL, Ebert BL, Gabriel S, Rustgi AK, Antonescu CR, Ladanyi M, Letai A, Garraway LA, Loda M, Beer DG, True LD, Okamoto A, Pomeroy SL, Singer S, Golub TR, Lander ES, Getz G, Sellers WR, Meyerson M. The landscape of somatic copy-number alteration across human cancers. Nature. 2010 Feb 18;463(7283):899-905. doi: 10.1038/nature08822.'}, {'pmid': '35091455', 'type': 'BACKGROUND', 'citation': 'Tokatlian T, Asuelime GE, Mock JY, DiAndreth B, Sharma S, Toledo Warshaviak D, Daris ME, Bolanos K, Luna BL, Naradikian MS, Deshmukh K, Hamburger AE, Kamb A. Mesothelin-specific CAR-T cell therapy that incorporates an HLA-gated safety mechanism selectively kills tumor cells. J Immunother Cancer. 2022 Jan;10(1):e003826. doi: 10.1136/jitc-2021-003826.'}], 'seeAlsoLinks': [{'url': 'http://www.a2bio.com', 'label': 'A2 Biotherapeutics Inc.'}]}, 'descriptionModule': {'briefSummary': "The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\\*02 expression.\n\nThe main questions this study aims to answer are:\n\nPhase 1: What is the recommended dose that is safe for patients\n\nPhase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells\n\nParticipants will be required to perform study procedures and assessments, and will also receive the following study treatments:\n\nEnrollment and Apheresis in BASECAMP-1 (NCT04981119)\n\nPreconditioning Lymphodepletion (PCLD) Regimen\n\nTmod CAR T cells at the assigned dose", 'detailedDescription': "This is a seamless phase 1/2, multi-center, open-label study that enrolls adults with recurrent unresectable, locally advanced, or metastatic (considered non-curative) CRC, NSCLC, PANC, OVCA, MESO or other solid tumors with MSLN expression. Subjects must be germline HLA-A\\*02 heterozygous, with tumors that express MSLN and have lost HLA-A\\*02 expression. This study has two arms: Arm 1 is a study of A2B694 and Arm 2 is a study of A2B543.\n\nThe purpose of Phase 1 of this study is to determine the safety and the optimal dose of the Tmod products (after PCLD) in participants with solid tumor disease. The purpose of Phase 2 of this study is to determine the further safety and efficacy (how well it treats the solid tumor disease) of the Tmod products.\n\nThe treatment available for these cancers and other solid tumors can be toxic, debilitating, and fatal. In the recurrent unresectable, locally advanced, or metastatic setting, the intent of standard of care treatment is typically palliative rather than curative, and has not changed significantly in several decades. A2 Bio hypothesizes that Tmod CAR T-cell therapy will enable the killing of tumor target cells (those cells that express MSLN and have loss of heterozygosity \\[LOH\\] for HLA-A\\*02 protein). Additionally, normal healthy cells that maintain HLA-A\\*02 expression and co-express MSLN (eg, lung tissue) will not be targeted due to the blocker portion of the Tmod CAR T cell that acts as a self-regulated safety switch that protects normal tissue from damage. A2 Bio believes this will provide a therapeutic safety window compared to previous solid tumor targeting therapies. This hypothesis will be explored in the study.\n\nParticipants for this study must enroll and have their T cells collected (apheresis) in the pre-screening BASECAMP-1 study (NCT04981119). T cells are collected, processed and stored for each participant. Upon disease progression the participant may screen for this study (EVEREST-2) and the participant's T cells are manufactured and then infused following PCLD regimen. There is no time requirement between the studies, and patients may go directly from BASECAMP-1 to EVEREST-2 based on their own disease course."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\\*02 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, OVCA, MESO, or other solid tumors with MSLN expression. Measurable disease is required with lesions of ≥1.0 cm by CT.\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long term safety follow up\n\nKey Exclusion Criteria:\n\n1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. MESO with pleural involvement extending into the peritoneum\n5. Cancer therapy within 3 weeks or 3 half lives of infusion\n6. Radiotherapy within 28 days of infusion\n7. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n8. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated\n9. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year\n10. Requires supplemental home oxygen\n11. Females of childbearing potential who are pregnant or breastfeeding\n12. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion'}, 'identificationModule': {'nctId': 'NCT06051695', 'acronym': 'EVEREST-2', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression', 'organization': {'class': 'INDUSTRY', 'fullName': 'A2 Biotherapeutics Inc.'}, 'officialTitle': 'A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Autologous Logic-gated Tmod™ CAR T Products, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression', 'orgStudyIdInfo': {'id': 'A2B694-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: A2B694', 'description': 'Patients receive preconditioning lymphodepletion (PCLD) regimen followed by a single dose of A2B694 intravenously on day 0', 'interventionNames': ['Biological: A2B694', 'Diagnostic Test: xT CDx with HLA-LOH Assay']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: A2B543', 'description': 'Patients receive preconditioning lymphodepletion (PCLD) regimen followed by a single dose of A2B543 intravenously on day 0', 'interventionNames': ['Biological: A2B543', 'Diagnostic Test: xT CDx with HLA-LOH Assay']}], 'interventions': [{'name': 'A2B694', 'type': 'BIOLOGICAL', 'otherNames': ['Tmod CAR T-cell Therapy'], 'description': 'Autologous logic-gated Tmod CAR T cells', 'armGroupLabels': ['Arm 1: A2B694']}, {'name': 'A2B543', 'type': 'BIOLOGICAL', 'otherNames': ['Tmod CAR T-cell Therapy'], 'description': 'Autologous logic-gated Tmod CAR T cells', 'armGroupLabels': ['Arm 2: A2B543']}, {'name': 'xT CDx with HLA-LOH Assay', 'type': 'DIAGNOSTIC_TEST', 'description': 'An investigational next generation sequencing (NGS) in vitro diagnostic (IVD) medical device', 'armGroupLabels': ['Arm 1: A2B694', 'Arm 2: A2B543']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Kimmel', 'role': 'CONTACT', 'email': 'Stephanie.Kimmel@bannerhealth.com'}, {'name': 'Matthew Ulrickson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Banner Health', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jona Plevin', 'role': 'CONTACT', 'email': 'jplevin@health.ucsd.edu'}, {'name': 'Sandip Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCSD Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90404', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexis Stamper', 'role': 'CONTACT', 'email': 'AStamper@mednet.ucla.edu'}, {'name': 'J. Randolph Hecht, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kayla McDaniel', 'role': 'CONTACT', 'email': 'mcda59@stanford.edu'}, {'name': 'Oliver Dorigo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rhoda Romain', 'role': 'CONTACT', 'email': 'Romain.Rhoda@mayo.edu'}, {'name': 'Yanyan Lou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nathana Zelleke', 'role': 'CONTACT', 'email': 'Nathana.Zelleke@moffitt.org'}, {'name': 'Monica Avila, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Teri Heddlesten Rediske', 'role': 'CONTACT', 'email': 'HeddlestenRediske.Teri@mayo.edu'}, {'name': 'Julian Molina, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amberly Scott', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'amberly@wustl.edu'}], 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Salman Punekar, MD', 'role': 'CONTACT', 'email': 'salman.punekar@nyulangone.org'}, {'name': 'Peter Warren', 'role': 'CONTACT', 'email': 'Peter.Warren@nyulangone.org'}], 'facility': 'NYU Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dudbeth Brown', 'role': 'CONTACT', 'email': 'Dudbeth.Brown@osumc.edu', 'phone': '614-685-7034'}, {'name': 'Kai He, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)', 'role': 'CONTACT', 'email': 'CTIP@VUMC.ORG', 'phone': '1-800-811-8480'}, {'name': 'Cathy Eng, M.D., FACP, FASCO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shelby Colden', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'scolden2@fredhutch.org'}, {'name': 'David Zhen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Clinical Trials', 'role': 'CONTACT', 'email': 'ClinicalTrials@a2bio.com', 'phone': '310-431-9180'}], 'overallOfficials': [{'name': 'John Welch, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'A2 Biotherapeutics'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'Data will be available within 1 year of the completion of the study, the length of time of availability is to be determined.', 'ipdSharing': 'YES', 'description': 'Study data will be shared within 1 year of study completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A2 Biotherapeutics Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Tempus AI', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}