Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk...
T-cell Acute Lymphoblastic LeukemiaT-Cell Acute Lymphoblastic LymphomaA Phase I trial to determine the safety of targeted immunotherapy with daratumumab (DARA) IV after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) for children, adolescents, and young adults (CAYA) with high risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy). Pre- and post-HCT NGS-MRD studies will be correlated with outcomes in children, adolescents, and young adults with T-ALL undergoing allogeneic HCT and post-HCT DARA treatment. The study will also evaluate T-cell repertoire and immune reconstitution prior to and following DARA post-HCT treatment and correlate with patient outcomes.
CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia
Acute Lymphoblastic LeukemiaAdult B-CellThis is a single arm, open-label, single-center, phase I/II study to determine the safety and efficacy of CD19 CAR-T( ssCART-19) combined with feeding T cells (FTCs) as consolidation therapy in patients diagnosed with de novo Philadelphia chromosome positive CD19+ B-ALL. The study will contain the following sequential phases: screening, lymphocyte apheresis, induction and consolidation chemotherapies combined with tyrosine kinase inhibitors. Once in complete response, patients will receive four cycles of ssCART-19s, namely one cycle of ssCART-19 infusion followed by another three cycles of ssCART-19 and FTC infusion. The role of FTCs is to mimic leukemia cells. Therefore, they are expected to stimulate in vivo expansion and persistence of ssCART-19. Considering the limited number of lymphocytes obtained by a single apheresis from patients and cost-efficacy, in addition to safety, we will explore the range of biologically active doses of FTCs in a phase I study. Based on preclinical data, FTCs stimulation of ssCART-19 at a ratio of 1:1 could achieve the best activation response, so 5×106/kg dosage of FTCs was set as the initial dosage in the study, and lower dose was also evaluated. In this study, FTCs will be administered at the dose of 5×106/kg, 3.25×106/kg or 2×106/kg two hours after ssCART-19 infusion on day 1 and once again administered at the same dose on day 8. After ssCART-19 and FTCs infusion, efficacy will be assessed by detecting molecular response for 6 months, PFS and OS will be followed up for 2 years. In phase II, we will expand the study at optimal biological doses of FTCs, and further evaluate the efficacy and safety of the innovative combination therapy of CD19 CAR-T and FTCs.
Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients...
Acute Lymphoblastic Leukemia RecurrentAcute Lymphoblastic Leukemia5 moreThis Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years of age with R/R AML, MLL, or ALL. The study will be performed in 2 parts: a Dose Titration for Day 1 study (Part 1) followed by a Dose Escalation Part (Part 2) of INA03 used as monotherapy.
A Study of Engineered Donor Grafts (Orca-T) in Recipients Undergoing Allogeneic Transplantation...
Acute Myeloid LeukemiaAcute Lymphoid Leukemia5 moreThis study will evaluate the safety, tolerability, and efficacy of an engineered donor graft ("Orca-T", a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.
Modified Immune Cells (CD19/CD20 CAR-T Cells) in Treating Patients With Recurrent or Refractory...
CD19 PositiveCD20 Positive12 moreThis phase I trial studies the side effects and best dose of CD19/CD20 chimeric antigen receptor (CAR) T-cells when given together with chemotherapy, and to see how effective they are in treating patients with non-Hodgkin's B-cell lymphoma or chronic lymphocytic leukemia that has come back (recurrent) or has not responded to treatment (refractory). In CAR-T cell therapy, a patient's white blood cells (T cells) are changed in the laboratory to produce an engineered receptor that allows the T cell to recognize and respond to CD19 and CD20 proteins. CD19 and CD20 are commonly found on non-Hodgkin?s B-cell lymphoma and chronic lymphocytic leukemia cells. Chemotherapy drugs such as fludarabine phosphate and cyclophosphamide can control cancer cells by killing them, by preventing their growth, or by stopping them from spreading. Combining CD19/CD20 CAR-T cells and chemotherapy may help treat patients with recurrent or refractory B-cell lymphoma or chronic lymphocytic leukemia.
A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and...
Acute Lymphoblastic LeukemiaRelapsed Pediatric ALL1 moreThis is a phase II clinical study to evaluate the safety and efficacy of pCAR-19 B cell autologous infusion preparation in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.
Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL
T-cell Acute Lymphoblastic LeukemiaIn this study, the investigators are hypothesizing that daratumumab-hyaluronidase will effectively treat T-ALL in patients who have persistent or recurrent MRD following treatment with chemotherapy.
Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia...
ALLChildhood B-Cell2 moreThe objective of the trial is to evaluate the safety, clinical toxicity and in vivo immunological effects of MOR00208 in pediatric patients with acute lymphoblastic leukemia who showed newly emerging or persistent MRD after a first stem cell transplantation, received stem cell transplantation without having reached a sufficient molecular remission prior to transplant (defined as MRD ≥10E-4) irrespective of MRD after SCT or underwent a second or subsequent stem cell transplantation irrespective of MRD after SCT. Part I: to determine the recommended dose of MOR00208 in pediatric patients Part II: to evaluate the time until hematological relapse or increase of MRD
Study of Brexucabtagene Autoleucel Plus Dasatinib in Adults With Acute Lymphoblastic Leukemia
Lymphoblastic LeukemiaTo assess the feasibility of oral dasatinib pulses (3 consecutive days per week) during the first month following infusion of brexucabtagene autoleucel (Tecartus) in adults with relapsed or refractory B-cell acute lymphoblastic leukemia.
Clinical Study of Anti-CD1a CAR-T in the Treatment of R/R Acute T-lymphoblastic Leukemia/Lymphoblastic...
Acute T-lymphoblastic LeukemiaAcute T-lymphoblastic LymphomaTo evaluate the efficacy and safety of anti-CD1a CAR-T in the treatment of relapsed refractory acute T-lymphoblastic leukemia/lymphoblastic lymphoma.