[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07070219":3,"trial-entities:NCT07070219":170,"trial-summary:NCT07070219":175},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":29,"interventions":32,"primary_outcomes":40,"secondary_outcomes":48,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":63,"locations":67,"central_contacts":162,"overall_officials":167,"references":168,"see_also_links":169},"NCT07070219","BHCT-CTD402-201","A Study of CTD402 in T-ALL\u002FLBL Patients","A Single-Arm, Open-Label, Multi-Center, Phase 1b\u002F 2 Study to Evaluate the Safety, Efficacy, and Cellular Pharmacokinetic Profile of CTD402 in Participants With Relapsed\u002FRefractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and Lymphoblastic Lymphoma (T-LBL) (TENACITY-01)","RECRUITING","2028-12-30","2026-08","2026-08-19","2025-10-07","Imviva Bio","INDUSTRY",true,"The goal of the TENACITY-01 clinical trial is to learn if CTD402 UCART is safe and effective for relapsed\u002Frefractory T-ALL\u002FLBL patients.\n\nParticipants with relapsed\u002Frefractory T-ALL\u002FLBL over the age of 1 year will be eligible to participate.\n\nParticipants will receive one infusion of CTD402 on Day 0 and will be evaluated for anti-tumor activity by an independent review committee based on the NCCN criteria for T-ALL and the Lugano 2014 criteria for T-LBL.\n\nPatients will be followed for up to 24 months in this study and will be required to enroll under a separate long term follow up protocol to be followed for up to 15 years.","TENACITY-01 is a single-arm, open-label, multi-center, Phase 1b\u002F2 study to assess the safety and efficacy of CTD402 in pediatric and adolescents (≥ 1 to 17 years) and adult participants (≥ 18 years) with relapsed\u002Frefractory (r\u002Fr) T-ALL\u002FLBL or T-ALL\u002FLBL patients in remission but with MRD. The Phase 1b portion of the study will enroll up to 18 participants to evaluate the safety and establish the RP2D of CTD402 in both cohorts independently, which may be different. Up to 100 participants will be enrolled in the Phase 2 portion of the study to further confirm the efficacy and safety of CTD402; 36 participants will be enrolled in the R\u002FR cohort and 66 participants will be enrolled in the MRD positive cohort.\n\nBoth the phase 1b and phase 2 portions will consist of the following sequential phases: screening (up to 2 weeks), lymphodepletion period (within 7 days prior to treatment), CTD402 treatment (a single dose), primary follow-up period (up to 2 years). Once a participant receives the first dose of lymphodepleting chemotherapy regimen, the participant will be considered enrolled into the study.\n\nLong term follow-up will be conducted under a separate protocol until 15 years following CTD402 infusion for survival, toxicity, RCR monitoring, and secondary malignancy.",[19,20],"Acute Lymphocytic Leukemia Refractory","Lymphoma, Lymphoblastic",[22,23],"CAR-T Therapy","relapsed\u002Frefractory","INTERVENTIONAL","TREATMENT",[27,28],"PHASE1","PHASE2",{"count":30,"type":31},118,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","CTD402 CAR T Cell Injection","CAR T cells",[38,39],"R\u002FR T-ALL\u002FLBL","T-ALL\u002FLBL in remission but with minimal residual disease",[41,45],{"measure":42,"description":43,"timeFrame":44},"Safety Profile","Incidence of dose limiting toxicities including incidence of adverse events and graft vs host disease","24 months",{"measure":46,"description":47,"timeFrame":44},"Response Evaluation","Percentage of participants who achieve overall complete remission (OCR) assess by an independent review committee",[49],{"measure":50,"description":51,"timeFrame":44},"Characterize the cPK profile of CTD402","CTD402 cellular pharmacokinetic (PK)","ALL","1 Year",null,false,{"inclusion":57,"exclusion":61,"raw_text":62},[58,59,60],"Relapsed or refractory disease after two or more lines of systemic therapy;","The first relapse occurs within 12 months after first remission;","Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period.",[],"Key Inclusion Criteria:\n\n1. Male or female, ≥ 1 year of age.\n2. Participants with body weight ≥ 40 kilogram.\n3. A) Relapsed or refractory T-ALL\u002FLBL or MRD positive defined as one of the following:\n\n   * Relapsed or refractory disease after two or more lines of systemic therapy;\n   * The first relapse occurs within 12 months after first remission;\n   * Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period.\n\n   B) Minimal Residual Disease (MRD) positive T-ALL\u002FLBL is defined as evidence of MRD, defined as \\\u003C 5% blasts in bone marrow but ≥ 1 cancer cell in 1,000 cells determined by NGS ClonoSEQ® and\u002For other regionally acceptable methodologies (e.g., EuroMRD guidelines).\n4. The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.\n5. Adequate organ function\n6. ECOG of 2 or less or Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants \\\u003C 16) at screening.\n\nKey Exclusion Criteria:\n\n1. Participants with concomitant genetic syndromes associated with bone marrow failure states or any other known bone marrow failure syndrome.\n2. Active central nervous system (CNS) involvement\n3. Participants with following cardiac conditions will be excluded:\n\n   1. History of heart failure New York Heart Association (NYHA) class III or IV;\n   2. History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment.\n4. Primary immune deficiency.\n5. Presence of uncontrolled infections.\n6. Known history of infection with the human immunodeficiency virus (HIV); hepatitis C virus and syphilis.\n7. Active or latent hepatitis B virus infection\n8. Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.",[64,65,66],"CHILD","ADULT","OLDER_ADULT",[68,82,91,99,107,117,127,139,151],{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":79},"Stanford University","Palo Alto","California","94304","United States",[75],{"name":76,"role":77,"email":78},"Lori Muffly, MD","CONTACT","scicto-trialposting@stanford.edu",{"lat":80,"lon":81},37.44188,-122.14302,{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":73,"geoPoint":88},"Colorado Blood Cancer Institute","WITHDRAWN","Denver","Colorado","80218",{"lat":89,"lon":90},39.73915,-104.9847,{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":73,"geoPoint":96},"University of Chicago","Chicago","Illinois","60637",{"lat":97,"lon":98},41.85003,-87.65005,{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":73,"geoPoint":104},"Mayo Clinic - Rochester","Rochester","Minnesota","55905",{"lat":105,"lon":106},44.02163,-92.4699,{"facility":108,"status":8,"city":109,"state":109,"zip":110,"country":73,"contacts":111,"geoPoint":114},"Memorial Sloan Kettering Cancer Center","New York","11101",[112],{"name":113,"role":77},"Mark Geyer, MD",{"lat":115,"lon":116},40.71427,-74.00597,{"facility":118,"status":8,"city":119,"state":109,"zip":120,"country":73,"contacts":121,"geoPoint":124},"Montefiore Einstein Comprehensive Cancer Center","The Bronx","10467",[122],{"name":123,"role":77},"Alex Sica, MD",{"lat":125,"lon":126},40.84985,-73.86641,{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":73,"contacts":132,"geoPoint":136},"Sarah Cannon Research Insitute","Nashville","Tennessee","37203",[133],{"name":134,"role":77,"phone":135},"Haydar Frangoul, MD","844-482-4812",{"lat":137,"lon":138},36.16589,-86.78444,{"facility":140,"status":8,"city":141,"state":142,"zip":143,"country":73,"contacts":144,"geoPoint":148},"MD Anderson Cancer Center","Houston","Texas","77030",[145],{"name":146,"role":77,"email":147},"Nitin Jain, MD","njain@mdanderson.org",{"lat":149,"lon":150},29.76328,-95.36327,{"facility":152,"status":8,"city":153,"state":154,"country":155,"contacts":156,"geoPoint":159},"Royal Prince Alfred","Sydney","New South Wales","Australia",[157],{"name":158,"role":77},"Ed Abadir, MD",{"lat":160,"lon":161},-33.86785,151.20732,[163],{"name":164,"role":77,"phone":165,"email":166},"Jan Davidson-Moncada, MD, PhD","917-573-8538","clinicaltrials@imvivabio.com",[],[],[],{"nct_id":4,"conditions":171,"biomarkers":174},[172,173],"Pre T-ALL","T Lymphoblastic Lymphoma",[],{"nct_id":4,"found":15,"summary":176,"prompt_version":185},{"design":177,"status":178,"heading":6,"summary":179,"follow_up":180,"word_count":181,"commitments":182,"compensation":183,"drugs_mentioned":184},"This is a single-arm, open-label study, meaning all participants receive the same treatment and everyone knows what treatment is being given. It will enroll about 54 participants in two phases to assess the safety and effectiveness of CTD402.","completed","This study, called TENACITY-01, is testing a treatment called CTD402 CAR T Cell Injection for people with T-cell Acute Lymphocytic Leukemia (T-ALL) or Lymphoblastic Lymphoma (LBL) that has come back or not responded to previous treatments. The main goals are to see if CTD402 is safe and how well it works. You might be able to join if you are 12 years or older, weigh at least 40 kilograms, and have T-ALL\u002FLBL that has relapsed or is refractory after two or more treatments, or if your first relapse happened within 12 months of your first remission. The study plans to enroll 54 participants and is currently unclear if it is recruiting.","Participants will be followed for up to 24 months within this study, and then for up to 15 years under a separate long-term follow-up protocol to monitor survival, side effects, and other health outcomes.",111,"You would receive one infusion of CTD402 after a period of chemotherapy. You will be followed for up to 24 months in this study, and then for up to 15 years under a separate long-term follow-up protocol.","Not stated in the trial record.",[35],"v2"]