Acute Myeloid Leukemia (AML)

Researchers are studying the use of 211astatineAt-BC8-B10, a radioactive substance linked to a monoclonal antibody, in patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. The trial is a phase III dose-escalation study focused on evaluating side effects and determining the best dose before patients undergo donor stem cell transplant. This approach aims to target cancer cells with radiation while minimizing effects on healthy cells. Participants receive 211At-BC8-B10 intravenously over 6 to 8 hours on day -7 and may also receive 131I-BC8-B10 on the same day. They receive fludarabine phosphate intravenously on days -4, -3, and -2, followed by total-body irradiation and peripheral blood stem cell transplant on day 0. Patients take cyclosporine orally or intravenously every 12 hours from days -3 to 56, with tapering schedules depending on donor type, and mycophenolate mofetil orally or intravenously starting shortly after transplant with dosing adjustments over time. Some participants may have imaging scans, bone marrow aspirate, and blood samples collected during the study. Throughout the study, patients are closely monitored for treatment effects and side effects, including dose-limiting toxicities up to 30 days post-transplant and veno-occlusive disease up to 60 days. Additional outcomes include engraftment, chimerism, graft versus host disease, remission status, and survival tracked up to two years. Follow-up visits occur at 100 days, then 6, 9, 12, 18, and 24 months after treatment to assess recovery and long-term effects.

Researchers are evaluating a radioactive agent linked to an antibody called 211At-BC8-B10 followed by donor stem cell transplant for patients with high-risk acute leukemia or myelodysplastic syndrome that has returned or is not responding to treatment. This phase III trial studies the side effects and best dose of this treatment. The antibody may interfere with cancer cell growth, and the transplant aims to help the patients bone marrow produce healthy blood cells. Additional medications are given to help prevent complications like graft versus host disease. Participants receive a preparative regimen including an infusion of 211At-BC8-B10 over 6-8 hours on day -8, followed by chemotherapy drugs fludarabine and cyclophosphamide over several days. Total-body irradiation TBI is given on day -1. On day 0, patients undergo peripheral blood stem cell or bone marrow transplant. After transplant, patients receive medications cyclophosphamide, mycophenolate mofetil, and tacrolimus to reduce the risk of graft versus host disease. Granulocyte colony-stimulating factor G-CSF is started on day 5 to support white blood cell recovery. Throughout the study, patients undergo bone marrow biopsies, aspirations, and blood sample collections. They are followed up at day 100 and then at 6, 9, 12, 18, and 24 months after treatment. Researchers monitor side effects including dose-limiting toxicities, remission rates, engraftment success, donor chimerism, immune recovery, graft versus host disease, survival, and disease-free survival. Patient health and safety are regularly assessed during and after treatment.

Researchers are evaluating the safety, side effects, best dose, and effectiveness of a combination conditioning treatment for donor stem cell transplantation in patients with high-risk acute myeloid leukemia AML, acute lymphoblastic leukemia ALL, and myelodysplastic syndrome MDS. This phase I trial studies a targeted radioimmunotherapy drug, 225Ac-DOTA-Anti-CD38 daratumumab, combined with chemotherapy drugs fludarabine and melphalan, and total marrow and lymphoid irradiation TMLI. Daratumumab targets CD38 on cancer and immune cells, potentially helping the immune system to attack cancer cells. Participants receive daratumumab intravenously followed by indium In 111-DOTA-daratumumab and actinium Ac 225-DOTA-daratumumab on day -15. Total marrow and lymphoid irradiation is given twice daily from days -8 to -5, fludarabine is given intravenously on days -4 to -2, and melphalan on day -2. On day 0, participants undergo hematopoietic cell transplantation HCT. Graft-versus-host disease GVHD prevention with sirolimus and tacrolimus starts on day -1. Throughout the study, participants undergo various scans, biopsies, and blood tests to monitor treatment effects and safety. Participants are monitored closely after transplantation with visits twice weekly for the first 100 days, then twice monthly up to six months, and monthly thereafter until immunosuppressive therapy is stopped without GVHD signs. Yearly follow-up continues for two years. Assessments include adverse events, survival rates, relapse, graft-versus-host disease incidence, infections, blood cell recovery, organ function, and drug distribution. The study aims to determine the maximum tolerated dose and evaluate overall safety and effectiveness of the treatment combination.

Researchers are evaluating the safety, side effects, and best dose of a new drug called 8-chloroadenosine combined with venetoclax in patients with acute myeloid leukemia AML that has returned or not responded to previous treatment. This phase 1 trial aims to understand how well this combination works to block cancer growth and prevent relapse in these patients. The study also explores the biological effects of the treatment and identifies markers related to response and resistance. Participants receive 8-chloroadenosine intravenously over 4 hours daily for five days, along with venetoclax taken orally once daily for 28 days. This treatment cycle repeats every 28 days for up to four cycles, unless the disease worsens or side effects become unacceptable. After completing the treatment cycles, patients are followed for up to one year with regular check-ups every 28 days to monitor their health and response. During the study, participants undergo assessments to track adverse events, dose-limiting toxicities, and treatment responses such as remission rates and survival outcomes. Researchers also measure drug levels in the blood and analyze gene and metabolic changes associated with the therapy. Follow-up visits continue for up to one year to evaluate the duration of remission, overall survival, and event-free survival, ensuring thorough monitoring of patient safety and treatment effects.

Researchers are evaluating SCTC21C, a biological treatment, in patients with relapsed or refractory CD38-positive hematologic malignancies. This multicenter, open-label Phase I trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary anti-tumor activity, and immune response to SCTC21C. The study includes a dose-finding stage to determine safe dosage levels and a dose-expansion stage to further evaluate selected doses. In the dose-finding stage, participants receive increasing doses of SCTC21C ranging from 0.01 mg up to 960 mg. In the dose-expansion stage, at least 20 participants are randomly assigned in a 11 ratio to receive two different doses determined from the earlier stage. SCTC21C is given by subcutaneous injection weekly for the first two cycles, then every two weeks for cycles three to six, and every four weeks thereafter until disease progression or unacceptable side effects occur. Participants will be closely monitored throughout the study with assessments including safety evaluations, adverse event tracking up to 45 days after the last dose, and measuring dose-limiting toxicities during the first 28-day cycle. Researchers will also evaluate tumor response over about one year of treatment. The study expects participants to have regular visits for treatment and monitoring, with the total duration varying depending on individual response and tolerability.

Researchers are investigating the safety and early effectiveness of a special treatment called CLL1 and CD38 dual-target CAR T cell injection for adults with relapsed or refractory acute myeloid leukemia AML. This phase I, open-label, dose-escalation study focuses on patients whose leukemia has returned or not responded to previous treatments. The trial aims to understand how well this dual-target CAR-T therapy works and its possible risks. The study involves a single treatment arm where participants receive the CAR T cell injection modified to target both CLL1 and CD38 proteins found on leukemia cells. The trial includes two phases the first uses an accelerated titration design to find a safe dose, and the second follows a 33 design to further evaluate dosing. Participants may undergo allogeneic hematopoietic stem cell transplantation after receiving the CAR-T cells if needed. During the study, participants will be closely monitored for dose-limiting toxicities within the first 28 days and tracked for adverse events over 96 weeks. Researchers will assess various outcomes including remission rates, survival, and cell behavior in the body. Participants will undergo regular tests and evaluations according to the study protocol, with follow-up visits scheduled for up to nearly two years after treatment to measure long-term safety and response.

Researchers are studying the safety and effectiveness of CD33 CAR-T cell therapy for patients with relapsed or refractory acute myeloid leukemia AML. This early phase 1 trial involves a single-arm, open-label, dose-escalation design to evaluate this biological treatment targeting CD33 in patients whose leukemia has returned or not responded to previous treatments. The study aims to better understand how this therapy works in this challenging condition. Participants will receive CD33 CAR T-cells through intravenous infusion. The trial uses a standard 33 dose escalation method with three different dose levels to determine the optimal dose. The trial plans to enroll between 15 and 27 participants, all receiving the experimental CAR-T cell treatment during the study period. During the study, participants will be closely monitored for safety by tracking dose-limiting toxicities up to 28 days after treatment and recording any treatment-emergent adverse events for up to two years. Researchers will also assess treatment responses such as complete remission, duration of remission, overall survival, and leukemia-free survival over periods ranging from 12 weeks to two years. Participants can expect regular evaluations including clinical exams, laboratory tests, and follow-up visits throughout the study and beyond to measure these outcomes and ensure safety.

Researchers are studying BP1002, a liposomal Bcl-2 antisense oligodeoxynucleotide, to evaluate its safety, tolerability, and potential effects in patients with refractory or relapsed acute myeloid leukemia AML. This Phase IIb study aims to find dose-limiting toxicities, biologically effective doses, pharmacokinetics, pharmacodynamics, and possible anti-leukemic activity of BP1002 alone and in combination with decitabine. The study is sponsored by Bio-Path Holdings, Inc. The study has two parts a dose escalation phase where BP1002 is given alone at increasing doses, and a dose expansion phase where BP1002 is combined with decitabine. The dose escalation part evaluates BP1002 monotherapy, while the expansion part assesses the combination treatment. Participants receive the study drugs according to these protocols to determine safety and effective dose recommendations. Participants will undergo regular assessments including blood and bone marrow tests to monitor treatment effects and safety. Researchers will track adverse events, laboratory results, heart rhythms, drug levels in the blood, and immune responses. The study will also evaluate leukemia response indicators and survival outcomes over time. The total participation includes follow-up periods to monitor safety and treatment effects, lasting up to several months.

Researchers are evaluating the tolerability and pharmacokinetics of TQB3455 tablets in patients with hematological malignancies, specifically acute myeloid leukemia AML and myelodysplastic syndrome MDS. TQB3455 is an inhibitor targeting the IDH2 enzyme. The study has two stages the first focuses on safety and tolerability of single or multiple doses in subjects with malignant blood tumors, while the second investigates the efficacy and safety of TQB3455 alone or combined with azacitidine in AML or MDS patients. During stage one, participants take TQB3455 tablets orally once daily for 28 consecutive days per treatment cycle. In stage two, participants receive the same TQB3455 tablet regimen, and some also receive azacitidine injections subcutaneously on days one through seven of each 4-week cycle. Azacitidine is a drug that affects DNA methylation. The study assesses both single and combination treatments through these cycles. Participants will be monitored with multiple assessments including dose-limiting toxicity and maximum tolerated dose during the first 28 days up to 48 weeks. Researchers will also measure overall remission rates, survival, response duration, and complete remission rates up to 48 weeks, along with detailed pharmacokinetic measurements of TQB3455 over multiple time points. Safety and tolerability are closely followed, and patients will be observed up to 96 weeks for overall survival outcomes.

Researchers are evaluating the safety, tolerability, and effectiveness of TQB3909 tablets combined with azacitidine in adults with myeloid malignancies, including acute myeloid leukemia and myelodysplastic syndromes. This open, multi-center clinical trial is designed as a Phase IbII study to better understand how this combination treatment works in these blood cancers. Participants receive TQB3909 tablets once daily in 28-day treatment cycles along with azacitidine. The study focuses on monitoring how well patients tolerate the treatment and its effects on their disease. The trial includes assessment of various response rates and survival outcomes over several weeks. Throughout the trial, participants undergo regular evaluations including monitoring for adverse events and laboratory tests for up to 24 weeks. Researchers measure remission rates, duration of remission, and survival outcomes up to 60 weeks. Participants safety and response to treatment are closely tracked during the study.