[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646090":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":29,"locations":39,"responsibleParty":59,"collaborators":20,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":20,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":42,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"National Institute of Blood and Marrow Transplant (NIBMT), Pakistan","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T arm","OTHER","5.1 Leukapheresis Leukapheresis will be performed at AFBMTC using standard large-volume apheresis technique on a validated apheresis platform. Non-mobilised peripheral blood mononuclear cells (PBMCs) will be collected targeting ≥1 × 10⁸ CD3+ T cells\u002Fkg (paediatric) or a minimum of 5 × 10⁸ CD3+ T cells total (adult). Pre-apheresis ALC and CD3+ count must both exceed 100\u002FµL. Leukapheresis products will be processed immediately for manufacturing or cryopreserved in validated storage at AFBMTC.\n\n5.2 CAR-T Cell Manufacturing 5.2.1 Vector Platform The anti-CD19 CAR transgene will be delivered using a replication-deficient, self-inactivating (SIN) third-generation lentiviral vector supplied by BIOCCUS (China). The vector encodes: anti-CD19 scFv (murine or humanised) - CD8α hinge\u002Ftransmembrane domain - 4-1BB costimulatory domain - CD3ζ activation domain. The lentiviral vector backbone incorporates safety modifications including deletion of viral enhancer elements in the 3' LTR (self-inactivati",[13],"Biological: CAR-T cell infusion",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CAR-T cell infusion","CAR-T Cell infusion therapy will be given",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Maryam Khan, MBBS, MRCP (UK), FCPS(Cl Haem)","National University of Medical Sciences","STUDY_CHAIR",{"name":27,"affiliation":24,"role":28},"Tariq Ghafoor","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":20,"email":34},"Nadia Sial, Ph.D","CONTACT","+923315582265","nadiaharif@gmail.com",{"name":36,"role":32,"phone":37,"phoneExt":20,"email":38},"Maryam Khan, MBBS, MRCP(UK), FCPS (Cl Haem)","+923366395758","maryam.khan9882@gmail.com",[40],{"facility":41,"status":42,"city":43,"state":20,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"National University of Medical Sciences, Clinical Trial Unit","RECRUITING","Rawalpindi","46000","Pakistan","PK",{"type":48,"coordinates":49},"Point",[50,51],73.0479,33.59733,{"lat":51,"lon":50},[54,56],{"name":55,"role":32,"phone":37,"phoneExt":20,"email":38},"Maryam Khan, MBBS,MRCP,FCPS(Cl Haem)",{"name":57,"role":32,"phone":33,"phoneExt":20,"email":58},"Nadia Sial, PhD","nadiaharif@gail.com",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Dr. Zaineb Akram","Assistant Professor","100646090","early-phase-1-car-t-cell-therapy-for-all-100646090",false,"NCT07695012","CAR-T Cell Therapy for ALL","A Pilot, Single-Arm, Open-Label Feasibility Study of Autologous Anti-CD19 Chimeric Antigen Receptor T-Cell (CAR-T) Therapy in Pediatric and Young Adult Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia (r\u002Fr B-ALL)","PAKCAR-ALL","Inclusion Criteria:\n\n* Inclusion Criteria\n\nAll of the following criteria must be met for enrolment:\n\n* 1\\. Age ≥5 years and ≤50 years at the time of consent\n* 2\\. Morphologically or immunophenotypically confirmed B-cell ALL (CD19+) meeting one or more of the following relapsed\u002Frefractory criteria:\n\n  * a. Second or subsequent bone marrow relapse (BM ≥2nd relapse)\n  * b. Any BM relapse following prior allogeneic HSCT, provided ≥6 months have elapsed from SCT to planned CAR-T infusion\n  * c. Primary refractory disease: failure to achieve CR after ≥2 cycles of standard induction chemotherapy; or chemorefractory: failure to achieve CR after ≥1 cycle of standard salvage chemotherapy for relapsed ALL\n  * d. Philadelphia chromosome-positive (Ph+) ALL: intolerant to or failed ≥2 lines of TKI therapy, or TKI contraindicated\n  * e. Ineligibility for allo-HSCT due to: comorbid disease, lack of suitable donor, contraindication to conditioning, or patient refusal after documented discussion with a BMT physician not part of the study team\n* 3\\. CD19 expression on tumour cells confirmed by multi-parameter flow cytometry within 3 months of enrolment (≥20% CD19-positive blasts required)\n* 4\\. Bone marrow blast burden ≥5% by morphological assessment at screening\n* 5\\. Adequate organ function at screening:\n\n  * a. Renal: Age-adjusted serum creatinine within normal limits per CTCAE paediatric reference tables, or GFR ≥30 mL\u002Fmin\u002F1.73m² (MDRD\u002FCKD-EPI)\n  * b. Hepatic: ALT\u002FAST ≤5× ULN; Total bilirubin \\\u003C2.0 mg\u002FdL\n  * c. Cardiac: LVEF ≥45% or LVSF ≥28% on echocardiogram (performed within 28 days of screening)\n  * d. Pulmonary: ≤Grade 1 dyspnoea; SpO₂ ≥91% on room air\n* 6\\. ECOG performance status ≤2 (age ≥16 years); Lansky performance scale ≥50 (age \\\u003C16 years)\n* 7\\. Life expectancy \\>12 weeks in the opinion of the investigator\n* 8\\. Adequate haematological status to tolerate leukapheresis (ALC ≥100\u002FµL and CD3+ count ≥100\u002FµL at time of apheresis, or acceptable stored product available)\n* 9\\. Patients who have undergone prior allo-HSCT must have: (a) no active acute GVHD (Grade ≥2) or extensive chronic GVHD; (b) no systemic immunosuppression for GVHD within 4 weeks prior to CAR-T infusion\n* 10\\. Written informed consent from patient (and parent\u002Fguardian if age \\\u003C18 years); assent from patients aged 7-17 years\n* 11\\. Willingness and ability to comply with study procedures, visit schedule, and long-term follow-up requirements including the 15-year gene therapy safety surveillance\n* 12\\. Negative pregnancy test (serum or urine β-hCG) within 48 hours of CAR-T infusion for females of childbearing potential (defined as post-menarche and not surgically sterilised) 4.3 Exclusion Criteria\n\nPatients meeting ANY of the following criteria will be excluded:\n\n* 1\\. Isolated extra-medullary (CNS-only or testicular-only) disease relapse without bone marrow involvement\n* 2\\. Active CNS involvement by ALL, defined as CNS-3 status per NCCN criteria (CSF blasts on cytospin, cranial nerve palsy, or brain parenchymal disease) at time of screening. Patients with prior CNS disease that has been effectively treated and cleared are eligible\n* 3\\. Burkitt's lymphoma\u002Fleukemia (mature B-ALL with sIg positive, FAB L3 morphology and\u002For MYC translocation)\n* 4\\. T-cell ALL or ambiguous lineage leukemia\n* 5\\. Known congenital bone marrow failure syndromes: Fanconi anaemia, Shwachman-Diamond syndrome, Kostmann syndrome, Diamond-Blackfan anaemia, or any other inherited aplastic anaemia. (Down syndrome patients are NOT excluded)\n* 6\\. Prior treatment with any CAR-T or adoptive T-cell product\n* 7\\. Prior anti-CD19 therapy of any kind (including blinatumomab) within 4 weeks of screening; or confirmed CD19-negative (antigen-loss) relapse on anti-CD19-based therapy. \\[Note: prior blinatumomab ≥4 weeks before screening is not exclusionary if CD19 positivity is confirmed at re-screening\\]\n* 8\\. Prior gene therapy with a viral vector (non-CAR gene therapy); or prior receipt of a gene-edited cellular product\n* 9\\. Active uncontrolled infection at screening (bacterial, fungal, viral or parasitic). Patients with controlled or treated infection may be enrolled at investigator discretion\n* 10\\. Active Hepatitis B (HBsAg positive, or anti-HBc positive with detectable HBV DNA); active Hepatitis C (anti-HCV positive with detectable HCV RNA); or HIV positive (confirmed within 8 weeks of screening)\n* 11\\. Active Grade 2-4 acute GVHD or active moderate\u002Fsevere chronic GVHD\n* 12\\. Prior malignancy other than B-ALL in the last 3 years (except carcinoma in situ of cervix or skin treated with curative intent, with no evidence of active disease)\n* 13\\. Investigational medicinal product (IMP) exposure within 30 days prior to screening, or within 5 half-lives, whichever is longer\n* 14\\. Pregnant or breastfeeding women\n* 15\\. Uncontrolled psychiatric condition or severe cognitive impairment that would preclude informed consent or compliance with protocol procedures\n* 16\\. Any medical condition that, in the opinion of the investigator, would place the patient at unacceptable risk from the study procedures\n* 17\\. Prohibited concomitant medications at time of CAR-T infusion (detailed in Section 6.5):\n\n  * Systemic corticosteroids \\>physiologic replacement (\\>12 mg\u002Fm²\u002Fday hydrocortisone equivalent) within 72 hours prior to CAR-T infusion\n  * Anti-T-cell antibody therapy (ATG, alemtuzumab) within 8 weeks prior to CAR-T infusion\n  * Systemic GVHD immunosuppression within 4 weeks prior to CAR-T infusion\n  * Donor lymphocyte infusion within 6 weeks prior to CAR-T infusion\n\nExclusion Criteria:\n\n\\-","ALL","5 Years","50 Years",{"count":75,"type":76},10,"ESTIMATED","INTERVENTIONAL",[79],"EARLY_PHASE1","Acute lymphoblastic leukemia (ALL) is the most common malignancy in children and the second most frequent acute leukemia in adults. B-cell ALL constitutes approximately 85% of all ALL diagnoses. In Pakistan, ALL represents the most prevalent haematological malignancy presenting to tertiary centres, with AFBMTC receiving the largest national referral volume for haematological malignancies and transplantation.\n\nFirst-line combination chemotherapy achieves complete remission (CR) in \\>95% of paediatric patients; however, 15-20% relapse. Outcomes following first relapse are substantially inferior: second-line salvage chemotherapy achieves CR2 in 30-50% of patients, and long-term event-free survival (EFS) after conventional chemotherapy alone is \\\u003C10%. Outcomes in adult ALL are even more dismal, with OS at 5 years below 40% even in first CR without allogeneic transplant.\n\nPatients with primary refractory ALL or multiply relapsed ALL have an unmet medical need for novel therapeutic approaches. The classical paradigm of chemotherapy followed by allogeneic haematopoietic stem cell transplantation (allo-HSCT) is limited by donor availability, conditioning-related mortality, and inability to achieve remission before transplant.",[82],"Relapsed Acute Lymphoblastic Leukemia (ALL)",[84],"B-ALL, Relapsed, Refractory, Adult, Childhood","2026-07-04",{"date":87,"type":88},"2026-07-10","ACTUAL",{"date":90,"type":88},"2026-06-01",{"date":92,"type":76},"2027-12-31",{"name":61,"class":6},1]