Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT05827835
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2023-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-04-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2023-03-30', 'studyFirstSubmitQcDate': '2023-04-11', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and level of AE and SAE', 'timeFrame': 'Baseline up to 28 days after CD7 CAR T-cells infusion', 'description': 'Adverse events assessed according to NCI-CTCAE v5.0 criteria'}], 'secondaryOutcomes': [{'measure': 'CAR-T cell expression', 'timeFrame': 'Evaluate at 1, 2, 3, 4, 8,12,16, 20 and 24 weeks after CAR-T infusion', 'description': 'CAR-T cell expression in vivo'}, {'measure': 'CAR-T related cytokine expression', 'timeFrame': 'Evaluate at 1, 2, 3 and 4 weeks after CAR-T infusion', 'description': 'CAR-T related cytokine expression'}, {'measure': 'Survival Rate （SR）', 'timeFrame': 'Evaluate at 6, 9, and 12 months', 'description': 'Survival Rate （SR）'}, {'measure': 'Time-To-Progression（TTP）', 'timeFrame': 'Month 2,3,4,6,12,18and 24', 'description': 'Time from the beginning of treatment to the progression of the disease'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Month 6,12,18and 24', 'description': 'Assessment of PFS at Month 6,12,18and 24'}, {'measure': 'Duration of remission,DOR', 'timeFrame': 'Up to 1 years after Treatment', 'description': 'The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion'}, {'measure': 'Overall response rate,ORR', 'timeFrame': 'Evaluate at 4, 8, and 12 weeks after CAR-T infusion', 'description': 'The proportion of patients with CR (complete remission) /CRi (complete remission with incomplete blood count recovery); The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).'}, {'measure': 'Clinical Benefit Rate（CBR）', 'timeFrame': 'Up to 24 weeks after Treatment', 'description': 'ORR+MR'}, {'measure': 'Disease Control Rate （DCR）', 'timeFrame': 'Up to 12 weeks after Treatment', 'description': 'CBR+SD'}, {'measure': 'Overall survival, OS', 'timeFrame': 'Up to 1 years after Treatment', 'description': 'The time from CAR-T infusion to death due to any cause'}, {'measure': 'Minimal Residual Disease', 'timeFrame': 'Up to 2 years after Treatment', 'description': 'MRD in CR and sCR patients'}, {'measure': 'Bone marrow transplantation STR', 'timeFrame': 'Evaluate at 4, 8,12,16 and 20 weeks after allogeneic hematopoietic stem cell transplantation', 'description': 'Monitoring the status of allogeneic hematopoietic stem cell transplantation using STR-PCR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['allo-HSCT', 'CD7 CAR-T'], 'conditions': ['Hematologic Diseases', 'Neoplasms']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, open-label, single-center, phase I/II study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of signed and dated informed consent form (ICF)\n* Male or female, older than 18 years (including 18 years)\n* Anticipated survival time more than 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia and Acute Myeloid Leukemia (2016. v1), patients diagnosed as CD7+ALL and AML\n* Consistent with r/r CD7+acute leukemia diagnosis, including any of the following conditions\n* a. No CR after standard chemotherapy\n* b. The first induction reaches CR, but CR ≤ 12 months\n* c. Patients with r/r CD7+acute leukemia have not responded to the first or multiple remedial treatments\n* d. Multiple recurrences\n* Philadelphia chromosome negative (Ph -) subjects; Or cannot tolerate tyrosine kinase inhibitor (TKI) treatment; Or Philadelphia chromosome positive (Ph+) subjects who did not respond to both TKI treatments\n* Normal lung function, oxygen saturation greater than 92% without oxygen inhalation\n* The blood biochemical test results are consistent with the following results\n* a. (AST) and (ALT) ≤ 2.5 × (ULN)\n* b. Total bilirubin ≤ 1.5 × ULN\n* c. 24-hour serum creatinine clearance ≥ 30 mL/min\n* d. Lipase and amylase ≤ 2 × ULN\n* Fertility capable men and women of childbearing age must agree to use effective contraception starting with the signing of an informed consent form until within 2 years after the use of the study drug. Women of reproductive age include pre menopausal women and women within 2 years after menopause. The blood pregnancy test for women of reproductive age must be negative at screening\n\nExclusion Criteria:\n\n* Patients with the history of epilepsy or other CNS disease\n* Pregnant or breastfeeding\n* Active infection with no cure\n* Patients with prolonged QT interval time or severe heart disease\n* Have experienced hypersensitivity or intolerance to any drug used in this study\n* Patients who received anticancer chemotherapy or other drug treatment within 2 weeks before screening\n* Previous malignant tumors that require treatment or have evidence of recurrence within the previous 5 years of screening\n* Clinically significant central nervous system lesions such as seizures, cerebral vascular ischemia/hemorrhage, dementia, cerebellar disease, psychosis, active central nervous system involvement, or cancerous meningitis\n* In the past 2 years, terminal organ damage caused by autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or the need for systematic application of immunosuppressive or other systemic disease control drugs\n* Severe active viral, bacterial, or uncontrolled systemic fungal infections; Genetic bleeding/coagulation disorders, a history of non-traumatic bleeding or thromboembolism, and other diseases that may increase the risk of bleeding\n* Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during this study\n* Participated in clinical trials of other drugs within 4 weeks or 5 drug half-lives (T1/2) before screening\n* Any situation that the researchers believe may increase the risk of patients or interfere with the test results."}, 'identificationModule': {'nctId': 'NCT05827835', 'briefTitle': 'CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'A Study to Evaluate the Efficacy and Safety of CD7CAR-T Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed CD7 Positive Malignant Hematologic Diseases', 'orgStudyIdInfo': {'id': 'TXB2022023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'R/R CD7+Malignant Hematologic Diseases', 'interventionNames': ['Drug: CD7 CAR-T cells injection', 'Other: Allogeneic hematopoietic stem cell transplantation']}], 'interventions': [{'name': 'CD7 CAR-T cells injection', 'type': 'DRUG', 'description': 'CD7 CAR T cells treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases', 'armGroupLabels': ['Treatment Group']}, {'name': 'Allogeneic hematopoietic stem cell transplantation', 'type': 'OTHER', 'description': 'In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Huang, MD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '86-13605714822'}, {'name': 'Yongxian Hu, MD', 'role': 'CONTACT', 'email': 'huyongxian2000@aliyun.com', 'phone': '+8615957162012'}], 'facility': 'The first affiliated hospital of medical college of zhejiang university', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'He Huang, MD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '+86-0571-87236476'}, {'name': 'Yongxian HU, MD', 'role': 'CONTACT', 'email': 'huyongxian2000@aliyun.com', 'phone': '+86-0571-87236476'}], 'overallOfficials': [{'name': 'He Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yake Biotechnology Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'Zhejiang University'}}}}