Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-11 @ 12:37 PM
Study NCT ID:
NCT06514794
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054218', 'term': 'Precursor T-Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study is divided into 2 cohorts:\n\nRelapsed/Refractory (R/R) Cohort will evaluate patients with relapsed or refractory disease\n\nMinimal Residual Disease (MRD) Positive Cohort will evaluate patients in complete remission with MRD positive disease.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'R/R Cohort - Composite Complete Response Rate', 'timeFrame': '24 months', 'description': 'CRc is defined as proportion of patients that achieve a complete remission (CR) + CR with incomplete hematologic recovery (CRi)'}, {'measure': 'MRD Pos Cohort - Response Rate', 'timeFrame': '24 months', 'description': 'Defined as the efficacy of WU-CART-007 to induce complete MRD negative response'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR-T Therapy'], 'conditions': ['T-cell Acute Lymphoblastic Leukemia', 'Lymphoblastic Lymphoma']}, 'descriptionModule': {'briefSummary': 'The T-RRex study evaluates the efficacy of WU-CART-007 for patients with Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) and to WU-CART-007 as a therapy to induce complete Minimum Residual Disease (MRD) negative response', 'detailedDescription': 'This is a Phase 2, single-arm, multi-center, open label study in patients with R/R T-ALL/LBL and T-ALL/LBL in remission but remaining MRD positive.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse/refractory or MRD positive\n* Age: Lower age limit of ≥ 1 year; adequate organ function\n* Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening.\n\nKey Exclusion Criteria:\n\n* Prior treatment with any anti-CD7 therapy.\n* Patients with decompensated hemolytic anemia.\n* Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression. Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.'}, 'identificationModule': {'nctId': 'NCT06514794', 'briefTitle': 'A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wugen, Inc.'}, 'officialTitle': 'A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed/Refractory Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-RRex)', 'orgStudyIdInfo': {'id': 'WUC007-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WU-CART-007', 'description': 'A CD7-directed chimeric antigen receptor (CAR) T-cell product.\n\nLymphodepletion', 'interventionNames': ['Biological: WU-CART-007']}], 'interventions': [{'name': 'WU-CART-007', 'type': 'BIOLOGICAL', 'description': 'A single IV infusion of WU-CART-007', 'armGroupLabels': ['WU-CART-007']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'tolaitan@coh.org'}, {'name': 'Ibrahim Aldoss, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angela Kang', 'role': 'CONTACT', 'email': 'akang@chla.usc.edu'}, {'name': 'Amber Medina', 'role': 'CONTACT', 'email': 'ammedina@chla.usc.edu'}, {'name': 'Deepa Bhojwani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katie Stricker', 'role': 'CONTACT', 'email': 'kstricker@wustl.edu'}], 'facility': 'Washington University Saint Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeremy Rubinstein, MD', 'role': 'CONTACT', 'email': 'jeremy.rubinstein@cchmc.org'}], 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19390', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brooke Leibfreid', 'role': 'CONTACT', 'email': 'leibfreidb@chop.edu'}], 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Ashish Bajel, M.D.', 'role': 'CONTACT', 'email': 'pcctu.haema@petermac.org'}], 'facility': 'Peter Mac Callum Cancer Institute', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Seong Lin Khaw, M.D.', 'role': 'CONTACT', 'email': 'clinicaltrialsmanager@rch.org.au'}], 'facility': "Royal Children's Melbourne", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Wugen Clinical Trials', 'role': 'CONTACT', 'email': 'clinicaltrials@wugen.com', 'phone': '314-501-1968'}], 'overallOfficials': [{'name': 'Cherry Thomas, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wugen, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wugen, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}