Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:24 AM
Study NCT ID:
NCT07485504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of DIT101 in Relapsed or Refractory Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to Maximum Concentration (Tmax) of CAR-T Cells in Peripheral Blood', 'timeFrame': 'up to 2 years after completion of the DIT101 infusion or until death, whichever occurs first.', 'description': 'To evaluate the time required to reach the maximum concentration of CAR-T cells in peripheral blood following DIT101 infusion.'}, {'measure': 'Area Under the Concentration-Time Curve (AUC) of CAR-T Cells in Peripheral Blood', 'timeFrame': 'up to 2 years after completion of the DIT101 infusion or until death, whichever occurs first.', 'description': 'To evaluate the total exposure of CAR-T cells in peripheral blood following DIT101 infusion.'}, {'measure': 'Level of Interleukin-6 (IL-6) in Peripheral Blood', 'timeFrame': 'Baseline, specified time points post-infusion, up to 2 years after completion of the DIT101 infusion.', 'description': 'To evaluate the concentration levels and changes from baseline of Interleukin-6 (IL-6) in peripheral blood at various time points following DIT101 infusion.'}, {'measure': 'Level of Interleukin-10 (IL-10) in Peripheral Blood', 'timeFrame': 'Baseline, specified time points post-infusion, up to 2 years after completion of the DIT101 infusion.', 'description': 'To evaluate the concentration levels and changes from baseline of Interleukin-10 (IL-10) in peripheral blood at various time points following DIT101 infusion.'}, {'measure': 'Level of Interferon-γ (IFN-γ) in Peripheral Blood', 'timeFrame': 'Up to 2 years after completion of the DIT101 infusion or until death, whichever occurs first.', 'description': 'To evaluate the concentration levels and changes from baseline of IFN-γ in peripheral blood at various time points following DIT101 infusion.'}, {'measure': 'Level of Tumor Necrosis Factor-α (TNF-α) in Peripheral Blood', 'timeFrame': 'Up to 2 years after completion of the DIT101 infusion or until death, whichever occurs first.', 'description': 'To evaluate the concentration levels and changes from baseline of TNF-α in peripheral blood at various time points following DIT101 infusion.'}], 'primaryOutcomes': [{'measure': 'Safety#Incidence and severity of adverse events (AEs)', 'timeFrame': '2 years after completion of the DIT101 infusion or until death, whichever occurs first.', 'description': 'To evaluate the possible adverse events after DIT101 infusion, including the incidence, and severity of AEs'}, {'measure': 'Safety#Incidence of Dose Limiting Toxicity (DLT)', 'timeFrame': '28 days after the first DIT101 infusion.', 'description': 'Incidence of dose limiting toxicities (DLTs) within 28 days after the first DIT101 infusion.'}], 'secondaryOutcomes': [{'measure': 'Duration of Remission (DOR)', 'timeFrame': '2 years after completion of the DIT101 infusion or until death, whichever occurs first.', 'description': 'Time from first achievement of Complete Response(CR), Complete Response with incomplete hematologic recovery(CRi) or Partial Response(PR) to disease relapse or death due to leukemia.'}, {'measure': 'Event-Free Survival (EFS)', 'timeFrame': '2 years after completion of the DIT101 infusion or until death, whichever occurs first.', 'description': 'Time from DIT101 infusion to earliest occurrence of any event: death after response, relapse, non-response, or treatment discontinuation due to leukemia- or treatment-related death, adverse events, or new anti-cancer therapy (excluding bridging hematopoietic stem cell transplantation (HSCT).'}, {'measure': 'Leukemia-Free Survival (LFS)', 'timeFrame': '2 years after completion of the DIT101 infusion or until death, whichever occurs first.', 'description': 'Time from first achievement of CR/CRi to disease relapse or death.'}, {'measure': 'Proportion of Responding Subjects Receiving HSCT', 'timeFrame': 'Up to 2 years following the completion of DIT101 infusion.', 'description': 'Percentage of subjects who achieve remission after DIT101 infusion and subsequently undergo hematopoietic stem cell transplantation.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 2 years after DIT101 infusion or until death, whichever occurs first.', 'description': 'Time from first DIT101 infusion to death from any cause.'}, {'measure': 'Maximum Concentration (Cmax) of CAR-T Cells in Peripheral Blood', 'timeFrame': 'up to 2 years after completion of the DIT101 infusion or until death, whichever occurs first.', 'description': 'To evaluate the peak expansion level of CAR-T cells in peripheral blood following DIT101 infusion.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed or Refractory Hematologic Malignancies']}, 'descriptionModule': {'briefSummary': "This study is a single-arm, open-label clinical trial designed to evaluate the safety and tolerability of DIT101 in adults with relapsed or refractory hematologic malignancies and to explore its potential anti-tumor effects.\n\nDIT101 is an investigational in vivo CAR-T cell therapy administered by intravenous infusion. After administration, it is intended to generate CAR-T cells within the patient's body that can recognize and attack tumor cells. Unlike approved autologous CAR-T therapies, DIT101 does not require collection and ex vivo genetic modification of the participant's own cells.\n\nThe study includes a screening period, DIT101 infusion treatment, a post-treatment intensive follow-up period of approximately 6 months, and a long-term follow-up period of up to 2 years, with visits every 3-6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 to \\<70 years, any gender.\n* Voluntarily provide written informed consent and willing to comply with all study procedures.\n* Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/LBL), or other relapsed/refractory hematologic malignancies as judged by the investigator and confirmed by the collaborating institution.\n* Tumor cells confirmed positive for the target antigen by immunophenotyping.\n* Bone marrow blast ≥5% at screening and/or presence of extramedullary disease.\n* For B-ALL/LBL patients, meets criteria for relapsed/refractory disease, including:\n\n * Primary refractory after ≥2 cycles of standard chemotherapy or not achieving CR after multiple salvage regimens;\n * Relapse within 12 months after CR or ≥12 months relapse after CR not achieving CR after subsequent standard therapy;\n * Relapse after hematopoietic stem cell transplantation;\n * Relapse after prior CAR-T therapy targeting the same antigen.\n* ECOG performance status 0-2.\n* Expected survival \\>3 months.\n* Adequate organ function, including:\n\n * Renal: creatinine clearance \\>45 mL/min;\n * Hepatic: total bilirubin ≤3×ULN, ALT/AST ≤5×ULN;\n * Coagulation: PT, APTT, or INR ≤1.5×ULN;\n * Cardiac: LVEF ≥50% within 1 month;\n * Pulmonary: SpO₂ ≥92% at rest on room air;\n * Hematologic and immune function considered sufficient to tolerate study treatment.\n* Women of childbearing potential must have a negative pregnancy test; women considered not of childbearing potential include those who are postmenopausal for ≥12 months or have undergone surgical sterilization (hysterectomy or bilateral oophorectomy).\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Known hereditary bone marrow failure syndromes (e.g., Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other known marrow failure syndromes).\n* Uncontrolled active central nervous system leukemia (CNSL; CNS2 or CNS3).\n* Prior anti-cancer therapy before screening, including:\n\n * Systemic chemotherapy within 1 week;\n * Systemic immunotherapy/targeted therapy (monoclonal antibodies, bispecific antibodies, ADCs, etc.) with last dose \\<5 half-lives or \\<4 weeks (whichever is shorter);\n * Donor lymphocyte infusion within 6 weeks;\n * CAR-T therapy or hematopoietic stem cell transplantation within 3 months;\n * Radiotherapy within 4 weeks (unless bone marrow reserve \\>5% and investigator judges it does not affect eligibility);\n * Persistent clinically significant toxicity from prior therapy not recovered to ≤CTCAE Grade 1 (except alopecia).\n* Uncontrolled severe active infection.\n* History of significant cardiac disease, including: severe heart failure (NYHA class III-IV), myocardial infarction or PCI/stent within 12 months, unstable angina, QTc \\>480 ms, or other clinically significant arrhythmia per investigator judgment.\n* History of CNS injury, seizure, stroke, or brain hemorrhage requiring treatment within 6 months.\n* Active viral infections:\n\n * HIV antibody positive, syphilis serology positive;\n * HBsAg \\>10⁶ IU/mL;\n * HCV antibody positive;\n * EBV positive (EBER or copy number above normal).\n* Need for long-term systemic corticosteroid therapy during DIT-101 infusion (local or inhaled steroids allowed).\n* Active autoimmune disease requiring treatment, immunodeficiency, or use of immunosuppressive therapy.\n* Acute or moderate-to-severe chronic graft-versus-host disease (GvHD) within 4 weeks prior to screening.\n* Known severe allergy to any component of DIT-101.\n* Women of childbearing potential or men unable to use effective contraception during DIT-101 infusion and for 1 year post-infusion; plans for pregnancy within 1 year post-infusion in male or female subjects or their partners.\n* Any condition that, in the investigator's opinion, may increase risk or interfere with study outcomes.\n* Prior malignancy other than hematologic malignancy, except:\n\n * Malignancy treated with curative intent and disease-free ≥2 years;\n * Non-melanoma skin cancer adequately treated with no current evidence of disease."}, 'identificationModule': {'nctId': 'NCT07485504', 'briefTitle': 'Safety and Efficacy of DIT101 in Relapsed or Refractory Hematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tcelltech Inc.'}, 'officialTitle': 'A Prospective, Single-Arm Study Evaluating the Safety and Efficacy of DIT101 in Subjects With Relapsed or Refractory Hematologic Malignancies', 'orgStudyIdInfo': {'id': 'DIT101-IBL001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'In Vivo CAR-T Therapy for Relapsed or Refractory Hematologic Malignancies', 'description': 'Participants with relapsed or refractory hematologic malignancies will receive 1-2 intraveneous administrations of in Vivo CAR-T (DIT101).', 'interventionNames': ['Biological: In Vivo CAR-T Therapy']}], 'interventions': [{'name': 'In Vivo CAR-T Therapy', 'type': 'BIOLOGICAL', 'description': 'Participants will receive 1 intravenous administration of DIT101, according to the study dosing regimen. A second dose at the same dose may be administered to eligible participants who show no response after initial treatment, upon sponsor approval.', 'armGroupLabels': ['In Vivo CAR-T Therapy for Relapsed or Refractory Hematologic Malignancies']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'country': 'China', 'facility': 'Hematology Hospital of Chinese Academy of Medical Sciences (Hematology Research Center of Chinese Academy of Medical Sciences)', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Rui Feng, MD', 'role': 'CONTACT', 'email': 'fengrui@tcelltech.com', 'phone': '+(86)13509312934'}, {'name': 'Xianzhen Chen, MM', 'role': 'CONTACT', 'email': 'chenxianzhen@tcelltech.com', 'phone': '+(86)18649725652'}], 'overallOfficials': [{'name': 'Gangxiong Huang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tcelltech Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tcelltech Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}