Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT04689204
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2020-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of CTA30X Cell Injection in Patients With Relapsed or Refractory CD19-positive B-line Hematological Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], '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'}, {'id': 'D008223', 'term': 'Lymphoma'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2020-12-25', 'studyFirstSubmitQcDate': '2020-12-25', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': 'Baseline up to 28 days after CTA30X infusion', 'description': 'Adverse events assessed according to NCI-CTCAE v5.0 criteria'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 2 years after CTA30X infusion', 'description': 'Incidence of treatment-emergent adverse events \\[Safety and Tolerability\\]'}], 'secondaryOutcomes': [{'measure': 'B-cell acute lymphocytic leukemia (B-ALL), Overall response rate (ORR)', 'timeFrame': 'Month 1 and 3', 'description': 'Assessment of ORR (ORR = CR + CRi ) at Month 1 and 3'}, {'measure': 'B-ALL, MRD negative overall response rate (MRD- ORR)', 'timeFrame': '3 months', 'description': 'Assessment of MRD negative overall response rate (MRD- ORR) at 3 months after CTA30X infusion'}, {'measure': 'B-ALL, ORR', 'timeFrame': 'Month 6, 12, 18 and 24', 'description': 'Assessment of ORR at Month 6, 12, 18 and 24'}, {'measure': 'B-ALL, Event-free survival (EFS)', 'timeFrame': 'Month 6, 12, 18 and 24', 'description': 'From the first infusion of CTA30X to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit'}, {'measure': "B cell non-hodgkin's lymphoma (B-NHL), Overall response rate (ORR)", 'timeFrame': 'weeks 4, 12, months 6, 12, 18 and 24', 'description': 'Assessment of ORR (ORR = CR + PR ) per Lugano 2014 criteria'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia', 'Non-hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'A study of CTA30X cell injection in the treatment of relapsed or refractory CD19-positive B-line hematological malignancies', 'detailedDescription': 'This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy: B-ALL and B-NHL. the selection of dose levels and the number of subjects are based on clinical tiral of similar foreign products. 3 groups of patients will be enrolled, 36 in each group. Primary objective is to explore the safety, main consideration is dose-related safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion criteria applicable to ALL only:\n\n1. Male or female aged ≥ 3 and \\<70 years old;\n2. Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);\n3. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):\n\n 1. CR not achieved after standardized chemotherapy;\n 2. CR achieved following the first induction, but CR duration is ≤ 12 months;\n 3. Ineffective after first or multiple remedial treatments;\n 4. 2 or more recurrences;\n4. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \\>5% (morphology) and/or \\>1% (Flow cytometry);\n5. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphiachromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;\n\nInclusion criteria applicable to NHL only:\n\n1. Male or female aged ≥ 18 and \\<70 years old;\n2. Histologically confirmed diagnosis per WHO Classification Criteria for Lymphocytic Tumors 2016, including DLBCL(NOS), follicular lymphoma, Chronic lymphoblastic leukemia/small lymphoblastic lymphoma transforms DLBCL, PMBCL and high grade B cell lymphoma;\n3. Relapsed or refractory DLBCL (meeting one of the following conditions):\n\n 1. No remission or recurrence after receiving second-line or above chemotherapy;\n 2. Primary drug resistance;\n 3. Recurrence after autologous hematopoietic stem cell transplantation\n\nApplicable standards for ALL and NHL:\n\n1. Total bilirubin ≤ 51umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8umol/L;\n2. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;\n3. No active infection in the lungs, blood oxygen saturation by sucking air is ≥92%;\n4. Estimated survival time ≥ 3 months;\n5. ECOG performance status 0 to 2;\n\nExclusion Criteria:\n\n1. Patients with extramedullary lesions, except those with CNSL (CNS-1) under effective control (for ALL patients only);\n2. Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/lymphoma per WHO Classification Criteria (for ALL patients only);\n3. Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome (for ALL patients only);\n4. Patients with intracranial extralateral lesions (cerebrospinal fluid tumor cells and/or intracranial lymphoma invasion shown by MRI) (for NHL patients only);\n5. Extensive involvement of gastrointestinal lymphoma (for NHL patients only);\n6. Radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening;\n7. Have a history of allergy to any of the components in the cell products;\n8. Prior treatment with any CAR T cell product or other genetically-modified T cell therapies;\n9. According to the New York heart association (NYHA) cardiac function classification criteria, Subjects with grade III or IV cardiac insufficiency;\n10. Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment;\n11. Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999);\n12. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n13. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n14. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis).\n15. History of other primary cancer, except for the following conditions:\n\n 1. Cured non-melanoma after resection, such as basal cell carcinoma of the skin;\n 2. Cervical cancer in situ, localized prostate cancer, ductal cancer in situ with disease-free survival ≥ 2 years after adequate treatment;\n16. Patients with autoimmune diseases requiring treatment, patients with immunodeficiency or requiring immunosuppressive therapy;\n17. Patients with graft-versus-host disease (GVHD);\n18. If HBsAg positive at screening, HBV DNA copy number detected by PCR in patients with active hepatitis B \\> 1000 (if HBV DNA copy number≤1000, routine antiviral therapy is required after enrollment), as well as CMV, hepatitis C, syphilis infection;\n19. Patients who have participated in any other clinical studies within 2 weeks prior to screening;\n20. Pregnant and breast-feeding women and the subjects who are fertile and unable to take effective contraceptive measures (regardless of the gender);\n21. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study."}, 'identificationModule': {'nctId': 'NCT04689204', 'briefTitle': 'A Study of CTA30X Cell Injection in Patients With Relapsed or Refractory CD19-positive B-line Hematological Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'A Study of CTA30X Cell Injection in the Treatment of Relapsed or Refractory CD19-positive B-line Hematological Malignancies', 'orgStudyIdInfo': {'id': 'BHCT-CTA30X-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Administration of CTA30X', 'description': 'Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.', 'interventionNames': ['Drug: CTA30X']}], 'interventions': [{'name': 'CTA30X', 'type': 'DRUG', 'otherNames': ['CTA30X cell injection'], 'description': 'CTA30X cell injection by intravenous infusion', 'armGroupLabels': ['Administration of CTA30X']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital，College of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'He Huang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nanjing Bioheng Biotech Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'Zhejiang University'}}}}