Clinical trials

This study is a single-center, single-arm, open-label, Phase II interventional clinical trial designed to evaluate the efficacy and safety of a CM336 and isatuximab regimen in patients with newly diagnosed multiple myeloma (NDMM) accompanied by renal impairment (\[eGFR\] \< 40 mL/min). Enrolled subjects will receive three consecutive cycles of induction therapy with CM336 in combination with isatuximab.

This study is a prospective, multicenter, randomized controlled study, planning to enroll 110 ITP patients who failed to respond to conventional-dose rhTPO (300 IU/kg/d) after 14 days of treatment (PLT \< 30×10⁹/L). After a 2-week washout period, they will be randomized to the rhTPO double-dose group (Group A) and EPAG-pfos group (Group B), with blood routine monitored weekly and doses adjusted according to platelet levels, comparing the response rates of the two groups at 6 weeks after switching treatment.

This is an investigator-initiated dose-finding clinical study with the primary objective of evaluating the safety of CD5CART in the treatment of subjects with relapsed and refractory CD5 hematological malignancies and to explore the MTD of CD5CART treatment of relapsed and refractory subjects with CD5 hematological malignancies. At the same time, the effectiveness and pharmacokinetic characteristics of CD5CART treatment of relapsed and refractory CD5 hematological tumors in subjects were explored

This is a clinical research study for people with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoma. The study will test a new treatment called "autologous nano CD5-CAR T cells". These are your own immune cells that have been changed in a lab to recognize and kill cancer cells. This study has two parts: Phase 1 to test the safety and best dose of the treatment, and Phase 2 to see how well it works. You may receive the study treatment if you meet all the eligibility criteria. The main things the study will look at are: how safe the treatment is, how many people's cancer goes away or gets better, and how long the effect lasts. Possible risks include fever, low blood pressure, and infection, which the study team will monitor closely.

This is a single-arm, open-label study to evaluate the efficacy and safety of CM336 combined with SOC therapy in patients with dynamically high-risk multiple myeloma.

The goal of this clinical trial is to learn whether CM336, a BCMA/CD3 bispecific antibody, can improve treatment outcomes when combined with isatuximab, lenalidomide, and bortezomib in adults with newly diagnosed primary plasma cell leukemia (pPCL). The study will also evaluate the safety of this treatment combination. The main questions it aims to answer are: How many participants achieve minimal residual disease (MRD) negativity after 9 treatment cycles? What side effects occur during treatment with CM336 combined with isatuximab, lenalidomide, and bortezomib? How many participants respond to treatment, and how long do those responses last? How long do participants remain free from disease progression, and how long do they survive after starting treatment? All participants will receive the study treatment. There is no comparison group in this study. Participants will: Receive CM336 by subcutaneous injection together with isatuximab, lenalidomide, and bortezomib in 28-day treatment cycles. Undergo regular blood tests, bone marrow examinations, and disease assessments to monitor treatment response and safety. Have stem cells collected after the first 3 treatment cycles if appropriate. Continue treatment for up to 18 cycles, followed by maintenance treatment with isatuximab and lenalidomide until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. Be monitored throughout the study for side effects.

This is a prospective, open-label, single-arm, umbrella phase 2 clinical trial enrolling 32 adult patients with newly diagnosed Philadelphia chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL). All patients receive a frontline treatment backbone consisting of low-dose chemotherapy combined with immuno-targeted agents and a BCL2 inhibitor. Subsequent treatment pathways are guided by MRD response, disease characteristics, and clinical decision-making, including antibody-based immunotherapy, CAR-T cell therapy, or hematopoietic stem cell transplantation. All patients continue protocol-defined maintenance therapy after consolidation. The primary endpoint is the complete remission rate with negative flow cytometric MRD after induction therapy. MRD is monitored longitudinally by flow cytometry, quantitative PCR, and immune repertoire sequencing. Safety is evaluated according to NCI CTCAE version 5.0.

This is a single-center, prospective, exploratory clinical study. It plans to enroll 30 adult patients with acute myeloid leukemia (AML) who have achieved first complete remission (CR1) after induction therapy and meet the indications for allogeneic hematopoietic stem cell transplantation (allo-HSCT). The aim is to evaluate the efficacy and safety of allo-HSCT following conditioning regimens with clofarabine, busulfan and melphalan.

The purpose of this prospective, multicenter, Phase 2 study is to evaluate the efficacy and safety of Mosunetuzumab in combination with the EZH2 inhibitor Zeprumetostat (SHR2554) in patients with follicular lymphoma (FL). The study plans to enroll approximately 80 patients, who will be assigned to three distinct cohorts: previously untreated high-risk FL (Cohort 1), previously untreated low-tumor-burden FL (Cohort 2), and relapsed or refractory FL (Cohort 3). The study consists of a safety run-in phase, which will be initially conducted in Cohort 1 to assess the tolerability of the combination therapy, followed by an expansion phase across all three cohorts to further evaluate the clinical outcomes.

This is a single-arm, open-label clinical trial evaluating the safety and preliminary efficacy of a novel induction regimen combining Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy. The study plans to enroll 27 participants. Patients will receive VAM induction therapy, followed by three cycles of intermediate-dose cytarabine consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.

This study is a single-arm, intervention, dose-escalation clinical trial to evaluate the safety of allogeneic CD19/BCMA-targeted CAR-γδT cell in the treatment of relapsed/refractory autoimmune diseases

This is a prospective clinical study to evaluate the safety and efficacy of R-CMOP in patients with newly diagnosed diffuse large B-cell lymphoma

This study aims to evaluate the efficacy of prophylactic ruxolitinib in adult patients at intermediate-to-high risk of severe acute GvHD, as predicted by the daGOAT model.

Evaluate the efficacy and safety of orelabrutinib, tafasitamab, and lenalidomide in the first-line treatment of patients with follicular lymphoma.

This is a prospective, open-label, randomized controlled trial to evaluate the efficacy of low-intensity chemotherapy combined with venetoclax and blinatumomab in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Patients will be randomized to receive or not receive venetoclax during the first three cycles of induction and consolidation therapy. All patients receive olverembatinib (a third-generation TKI) continuously and may receive up to 4 cycles of blinatumomab starting from the fourth cycle. The primary endpoint is the rate of BCR::ABL1 ≤0.01% at 90 days and event-free survival (EFS). Secondary endpoints include overall survival (OS), relapse-free survival (RFS), molecular relapse rate, MRD negativity rate by NGS, and cardiovascular events.

This open-label, non-randomized, phase II exploratory study aims to evaluate the efficacy and safety of combining pathway-specific tyrosine kinase inhibitors with chemotherapy and venetoclax in patients with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL). Patients are stratified by genetic alteration: those with ABL class fusions (ABL1, ABL2, PDGFRA, PDGFRB) receive olverembatinib, while those with JAK pathway alterations (CRLF2 rearrangement, JAK mutation/fusion, EPOR fusion, SH2B3 deletion, IL7R mutation) receive Gecacitinib. Both groups undergo sequential induction, consolidation, intensification, and maintenance therapy as per protocol. The primary endpoint is the rate of flow cytometry minimal residual disease (MRD)-negative complete remission (CR MRD-) at 3 months after induction therapy. Secondary endpoints include overall complete remission rate, NGS MRD-negative CR rate at 3 months, overall survival (OS), disease-free survival (DFS), relapse-free survival (RFS), cumulative incidence of relapse, and 60-day mortality.

This is a prospective, open-label, non-randomized cohort study evaluating the efficacy and safety of a pediatric-inspired chemotherapy regimen (IH-2014 based) combined with venetoclax and immunotherapy in adult patients with newly diagnosed Ph-negative Acute Lymphoblastic Leukemia (ALL). Patients aged ≥14years,≤60 years will be enrolled. Treatment includes induction, consolidation, early intensification, delayed intensification, and maintenance phases. The use and number of cycles of immunotherapy will be based on patient preference. The primary endpoint is Event-Free Survival (EFS) and MRD-negative CR rates after induction therapy(by flow cytometry and NGS). Secondary endpoints include Complete Remission (CR) rate, MRD-negative CR rates at 12 weeks (by flow cytometry and NGS), Overall Survival (OS), Relapse-Free Survival (RFS), and cumulative relapse rate.

This study is planned to prospectively evaluates the efficacy and safety of the zanubrutinib, obinutuzumab, and lenalidomide (ZGR) combination regimen in treatment-naïve follicular lymphoma (FL) patients in a Chinese population.

This is a prospective, open-label, single-arm clinical trial evaluating a treatment strategy for previously untreated Mantle Cell Lymphoma (MCL). The study will enroll patients who have not received prior systemic therapy for MCL. All patients will receive the ZGR induction regimen. Risk-adapted maintenance therapy will be applied: non-high-risk patients will receive lenalidomide and zanubrutinib maintenance for 1 and 2 years, respectively; high-risk patients will undergo CAR-T cell therapy followed by the same maintenance regimen. The primary objective is to assess the feasibility and preliminary efficacy of this treatment approach in the first-line setting of MCL.

The aim of this study is to analyze the safety of BAFF-R Chimeric Antigen Receptor T-Cell Injection (BAFF-R CAR-T) in participants with relapsed/refractory BAFF-R-positive B-cell lymphoma and explore the Maximum Tolerated Dose (MTD). The secondary objective of this study is to explore the efficacy of BAFF-R CAR-T in participants with relapsed/refractory BAFF-R-positive B-cell lymphoma. The study also aims to explore the pharmacokinetic characteristics of BAFF-R CAR-T in vivo and the impact of BAFF-R CAR-T on lymphocyte subsets in vivo.

Acute myeloid leukemia (AML) is a common hematological malignancy. Intensive chemotherapy is the main treatment in fit patients. Retrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations, the combination of azacitidine with Venetoclax showed an increased remission rate without improved survival. Since AML is a highly heterogeneous disease, it is not clear which genetic type of adult AML patients would benefit from Venetoclax combined with intensive chemotherapy. Therefore, this study intends to conduct a phase II clinical trial to investigate the efficacy of intensive chemotherapy combined with Venetoclax in adult AML patients, and reveal the efficacy of Venetoclax added to chemotherapy regimens for AML with different cytogenetic and molecular subgroups.

Venetoclax can bind to the BCL-2 protein, thereby initiating the apoptosis program and exerting anti-AML effects. The induction regimen combining venetoclax with hypomethylating agents (HMA) significantly improves the remission rate (over 60%) in elderly unfit AML patients and markedly prolongs survival in those achieving complete remission. Isocitrate dehydrogenase (IDH) 1 and 2 are involved in the citric acid cycle. Approximately 20% of AML patients carry IDH1 or IDH2 mutations, which lead to the reduction of α-ketoglutarate to 2-hydroxyglutarate (2-HG). 2-HG can cause histone methylation and inhibit TET2 activity, resulting in DNA hypermethylation, thereby affecting gene expression and cell differentiation. IDH mutations are more common in elderly patients and are often associated with cytogenetic abnormalities; they may also co-occur with FLT3-ITD, NPM1, or DNMT3A mutations. Ivosidenib is an IDH1 inhibitor, and previous studies have confirmed its safety and efficacy in AML treatment. According to adult AML treatment guidelines, IDH-mutated patients eligible for intensive chemotherapy may receive IDH inhibitors during induction therapy. Based on the study by Montesinos et al. on the role of ivosidenib and azacitidine in IDH-mutated AML, for patients ineligible for intensive chemotherapy, a new treatment option has been added: IDH1-mutated AML patients may receive ivosidenib (500 mg, days 1-28) combined with azacitidine (75 mg/m²/day for 7 days) in 28-day cycles, or ivosidenib monotherapy. Recent studies have shown that a triple-drug regimen comprising ivosidenib, venetoclax, and azacitidine demonstrates excellent efficacy and safety. In chemotherapy-ineligible patients, the triple regimen achieved a composite complete remission rate (CRc) of 86% and an overall response rate (ORR) of 92%. At a median follow-up of 27.4 months, the 2-year overall survival (OS) was 72%, and the 2-year event-free survival (EFS) was 72%. Therefore, this study aims to conduct a multicenter, single-arm clinical trial to preliminarily evaluate the long-term efficacy of this combination in adult AML.

The FMS tyrosine kinase 3 (FLT3) gene mutation occurs in 30% of newly diagnosed AML patients, leading to a higher relapse rate and mortality rate. In the past, multi-drug combination chemotherapy regimens had limited efficacy in newly diagnosed AML patients with FLT3 mutations, especially in those with FLT3-ITD. However, the FLT3 inhibitors greatly improved the survival of AML patients with FLT3 mutations. Although several studies have focused on the effectiveness of FLT3 inhibitor combination therapy for FLT3-mutated AML, further studies are needed to determine the optimal regimen and dosage. A triple regimen consisting of Gilteritinib, Venetoclax, and Azacitidine had shown good efficacy in unfit newly diagnosed FLT3-mutated AML patients. This clinical trial aims to determine the optimal triple regimen and investigate its efficacy in newly diagnosed fit FLT3-mutated AML patients.

This study is an open-label, single-arm early exploratory clinical study, aiming to evaluate the safety, tolerability and preliminary efficacy of IASO206 Injection (In Vivo CAR-T) in Patients with Relapsed/Refractory Autoimmune Hemolytic Anemia

Anemia is a global public health concern and is closely linked to dysfunction of brain cognitive neural networks, a key mechanism underlying cognitive impairment. Such deficits-including declines in memory, learning, processing speed, and executive function-reduce daily living abilities and increase risks of falls and depression. Functional near-infrared spectroscopy (fNIRS) enables real-time monitoring of oxygenated and deoxygenated hemoglobin fluctuations, reflecting brain network function. This study aims to identify affected neural network regions in anemic patients and visualize connectivity changes using heatmaps and arc-based mapping. The findings will support early detection of cognitive impairment and guide precise clinical interventions, ultimately informing individualized treatment strategies to enhance therapeutic outcomes and quality of life.