[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dr. Zaineb Akram\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100646460","phase-2-car-t-in-relapsedrefractory-multiple-myeloma-100646460",false,"NCT07689058","CAR-T in Relapsed\u002FRefractory Multiple Myeloma","Pilot, Open-Label, Single-Arm Study of Autologous BCMA-Directed CAR-T Cells in Patients With Relapsed\u002FRefractory Multiple Myeloma in Pakistan","Inclusion Criteria\n\n1. Male and female participants of age 18 years and above.\n2. Patients with a confirmed diagnosis of multiple myeloma according to IMWG diagnostic criteria.\n3. Received at least 3 prior multiple myeloma treatment lines of therapy or are double refractory to an IMiD and PI (refractory multiple myeloma as defined by IMWG consensus criteria). Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single line of therapy.\n4. Measurable disease at Screening as per IMWG criteria.\n5. ECOG Performance Status grade of 0 to 2.\n6. Adequate organ function: ANC\u002Fplatelets thresholds (unless cytopenias attributable to MM), LVEF ≥45%, adequate oxygenation; hepatic\u002Frenal criteria specified in Section 10.\n7. Negative pregnancy test for women of childbearing potential; agreement to effective contraception.\n8. Patients giving written informed consent to participate in the study after a full understanding of the implications and constraints of the study protocol.\n9. Understand the content of the ICF, and voluntarily sign the ICF (If the participant is unable to sign the ICF on their own due to illiteracy, an impartial witness is needed).\n10. The subject can understand the research process and is willing and able to comply with all research proposals and other requirements of the study.\n11. Willing and able to adhere to the prohibitions and restrictions specified in this protocol.\n\nExclusion Criteria\n\n1\\. Patients who will meet any of the following criteria will not be eligible to participate in the study.\n\n1. Prior treatment with CAR-T therapy directed at any target. Any therapy that is targeted to BCMA.\n2. Known active, or prior history of central nervous system (CNS) involvement, or exhibits clinical signs of meningeal involvement of multiple myeloma.\n3. Stroke or seizure within 6 months of signing the ICF.\n4. Uncontrolled active infection, including uncontrolled bacterial or fungal infection; active uncontrolled HBV\u002FHCV\u002FHIV.\n5. Clinically significant cardiac disease (e.g., NYHA III\u002FIV, recent MI), or severe pulmonary disease.\n6. Recent allogeneic HSCT with active GVHD or ongoing immunosuppression.\n7. Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment.\n8. Any other circumstances that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n\n   \\-\n\n   Exclusion Criteria:\n\n   \\-","ALL","18 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The treatment options for multiple myeloma have evolved significantly over the years, providing patients with a range of therapies tailored to their specific circumstances. The choice of treatment often hinges on various factors, including the aggressiveness of the disease, individual prognostic indicators like genetic markers, the overall physical condition of the patient, and any pre-existing health issues that may affect treatment decisions. Current therapeutic strategies include several classes of drugs, each working through different mechanisms. Proteasome inhibitors (PIs) disrupt the protein degradation process within myeloma cells, thereby promoting their death. Immunomodulatory drugs (IMiDs) modulate the immune system and inhibit tumor growth by enhancing the body's natural anti-cancer responses. Monoclonal antibodies specifically target cancer cells, marking them for destruction by the immune system. In cases where patients are eligible, autologous stem cell transplantation remains a viable option, offering the potential for long-term remission by replacing damaged bone marrow with healthy stem cells from the patient's own body.\n\nDespite these advancements, multiple myeloma continues to present significant challenges, as it often recurs even after initial successful treatment and remains an incurable disease. This highlights the urgent need for innovative therapeutic strategies that can effectively address resistance to existing treatments, ultimately aiming to improve patient outcomes and survival rates.",[26,27],"Multiple Myeloma Refractory","Multiple Myeloma in Relapse",[29],"CAR-T, Multiple Myeloma, Relapsed, Refractory","RECRUITING","2026-07-04",{"date":33,"type":34},"2026-07-08","ACTUAL",{"date":36,"type":34},"2026-06-01",{"date":38,"type":20},"2027-12-31",{"name":40,"class":41},"Dr. Zaineb Akram","OTHER_GOV",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":63,"leadSponsor":64,"locationsCount":65},"100646090","early-phase-1-car-t-cell-therapy-for-all-100646090","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\\-","5 Years","50 Years",{"count":19,"type":20},[54],"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.",[57],"Relapsed Acute Lymphoblastic Leukemia (ALL)",[59],"B-ALL, Relapsed, Refractory, Adult, Childhood",{"date":61,"type":34},"2026-07-10",{"date":36,"type":34},{"date":38,"type":20},{"name":40,"class":41},1,""]