NCT05849857Phase 2Recruiting
Oslo University Hospital · Helsinki University Hospital, Helsinki
In this clinical trial adult patients diagnosed with follicular lymphoma and relapse or progression of disease within 24 months of starting first line treatment will be treated with mosunetuzumab. This is a bispecific antibody, a new type of immunotherapy that redirects the bodies own immune cells (T-cells) to attack and kill the lymphoma cells. The main question the trial aims to answer is if mosunetuzumab works better than standard treatments in this sub-group of patients. Patients will receive mosunetuzumab as injections in the abdominal subcutaneous fat once a week for the three first doses, then every third week 7 times. If all signs of disease are gone as evaluated by PET-CT images, the treatment is stopped. If signs of disease remain on PET-CT images, the patients can receive treatment every third week for up to a total of one year. After the end of treatment, patients are followed two years in the trial for signs of progression or relapse.
Eligibility: 18 Years to · All · 1. Written informed consent according to ICH-GCP guidelines.
2. Age ≥ 18 years.
3. Follicular lymphoma grade 1-3a with a current relapse or progression within 24 months of starting 1st line treatment or refractory to 1st line treatment (POD24), more specifically:
1. Documented current relapse or progression of FL within 24 months of starting first line treatment containing a monospecific anti-CD20 antibody (such as rituximab or obinutuzumab with or without chemotherapy, small molecular inhibitors or immunomodulating agents such as lenalidomide).
2. Current lack of response/refractoriness to first line treatment, i.e., no objective response or documented progression within 6 months following at least four cycles of monotherapy with a monospecific anti-CD20 antibody (such as rituximab 375mg/m2 iv or 1400 mg SC or equal) or following at least three cycles of a monospecific anti CD20 antibody combined with chemotherapy, small molecular inhibitors or immunomodulating agents such as lenalidomide.
3. Received one prior treatment line of systemic therapy.
4. Patients may have had a period of watch and wait before the initiation of first line treatment.
5. Patients may have received localized radiotherapy previously.
4. At least one two-dimensionally measurable lesion with a longest diameter \>15mm.
5. WHO performance status 0-2. Patients with reduced WHO performance status (\> 2) can be considered if reduction in performance is caused by the lymphoma as determined by the investigator.
NCT05518851Phase IIRecruiting
Peking University First Hospital · Peking University Third Hospital, Beijing, Beijing Municipality
In order to further improve the diagnosis and treatment level of primary cutaneous lymphoma in China, the National Clinical Center for Skin and Immune Diseases established a standardized diagnosis and treatment center for primary cutaneous lymphoma to systematically and effectively understand the current treatment status of patients with primary cutaneous lymphoma, as well as the efficacy and safety of various treatment methods during practices, so as to further improve the diagnosis and treatment level of primary cutaneous lymphoma and help patients with primary cutaneous lymphoma.
Eligibility: 18 Years and older · All · * Patients from the participatin medical centers that has passed the data review of the National Clinical Center for Skin and Immune Diseases.
* Patients with a definitive pathological diagnosis of primary cutaneous lymphoma by skin biopsy.
NCT06733987Phase IIRecruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna · IRCCS Azienda Ospedaliero - Universitaria di Bologna, Bologna
This is a single-centre, observational, prospective and exploratory study, which involves the use of human tissues from patients affected by Relapsed/Refractory classic Hodgkin Lymphoma treated with pembrolizumab at the Departmental Diagnosis and Therapy program for chronic lymphoproliferative syndromes of the IRCCS AOU of Bologna. Peripheral blood samples will be used for the study and will be taken:
* before starting treatment with pembrolizumab.
* undergoing therapy with pembrolizumab (cycle 2 (C2), C3, C4, C8, C12).
Eligibility: 18 Years to · All · * Patients of both sexes aged ≥ 18 years at enrollment
* Patients affected by cHL R/R candidate to receive a treatment with Pembrolizumab
* Signature of informed consent
NCT05780034Phase 1Recruiting
Accutar Biotechnology Inc · Colorado Blood Cancer Institute, Denver, Colorado
This clinical trial is evaluating a drug called AC676 in participants with Relapsed/Refractory B-cell Malignancies. The main goals of the study are to:
* Identify the recommended dose of AC676 that can be given safely to participants
* Evaluate the safety profile of AC676
* Evaluate the pharmacokinetics of AC676
* Evaluate the effectiveness of AC676
Eligibility: 18 Years to · All · 1. Adult male and female patients, at least 18 years-of-age at the time of signature of the informed consent form (ICF).
2. Patients with histologically confirmed relapsed/refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), non-GCB Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL), or Waldenström Macroglobulinemia (WM).
3. Must have received at least 2 prior systemic therapies or have no other therapies to provide significant clinical benefit in the opinion of the Investigator or who are not amenable (intolerability, patient choice) to standard therapies.
NCT07306156Phase 1, Phase 2Recruiting
Zhimin Zhai · The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui
This is a Phase 1/Phase 2 open-label, single-arm clinical study of GP350 CAR-T for Relapse/Refractory and Epstein-Barr virus infection associated lymphoid neoplasms.
Each participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy, and an intravenous infusion of CAR-T cells.
Each participant will proceed through the following study procedures:
* Screening
* Enrollment/Leukapheresis
* Conditioning chemotherapy
* CAR T treatment
* Post-treatment assessment
* Long-term follow-up
Eligibility: 18 Years to 70 Years · All · 1. Diagnosis: Confirmed diagnosis of lymphoid neoplasms according to WHO-HAEM5 (Alaggio R. et al. doi:10.1038/s41375-022-01620-2);
2. Disease Assessment:
1. Criteria for Relapsed/Refractory lymphoid neoplasms: Meeting any one of the following three conditions: ① Failure to achieve at least a partial response (PR) per Lugano criteria after two cycles of standard first-line therapy; ② Disease progression within six months after achieving a response to first-line therapy, or progression after six months with no response to the original first-line or second-line regimen; ③ Relapse after hematopoietic stem cell transplantation.
2. Criteria for EBV Infection: Meeting any one of the following three conditions: ① Peripheral blood (plasma or whole blood) EBV DNA load ≥ 10³ copies/ml by quantitative PCR; ②Tumor cell GP350 positivity (≥10% of tumor cells by immunohistochemistry or flow cytometry); ③ Serological detection of EBV antibodies indicating any of the following: positive anti-VCA-IgM; positive anti-EA-IgG; or simultaneous positivity for anti-VCA-IgM, anti-VCA-IgG, and anti-EBNA-IgG.
3. At least one evaluable lymphoma lesion according to Lugano criteria, or confirmed active lytic EBV infection.
3. Performance Status: ECOG score 0-2 and expected survival ≥3 months;
4. Age: 18-70 years, regardless of sex;
5. Hematologic Criteria:
* Absolute neutrophil count (ANC) ≥1.0×10⁹/L;
* Hemoglobin \>60 g/L;
* CD3+ T-cell count \>0.5×10⁹/L;
* Platelet count \>30×10⁹/L;
6. Organ Function:
* Creatinine clearance ≥60 mL/min;
* ALT/AST ≤2× upper limit of normal (ULN);
* Total bilirubin ≤2× ULN;
* Left ventricular ejection fraction (LVEF) ≥50%, no pericardial effusion, and no clinically significant ECG abnormalities;
* Minimal or no pleural/ascitic fluid;
* Oxygen saturation ≥95%;
7. Contraception:
* Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception until the last follow-up;
* Male participants with fertile partners must agree to use effective contraception until the last follow-up;
8. Informed Consent: Psychologically stable, capable of understanding the study's purpose and procedures, willing to participate voluntarily, and able to provide signed informed consent and comply with protocol requirements.
NCT07555470Phase 2Recruiting
Institute of Hematology & Blood Diseases Hospital, China · Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin, Tianjin Municipality
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.
Eligibility: 18 Years to · All · * Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Adequate hematologic and organ function
* Female subjects of childbearing potential must have a negative serum pregnancy test and agree to use highly effective contraception; male subjects must agree to use effective contraception.
* Voluntary written informed consent
* Cohort 1- Previously Untreated High-Risk FL：
1. Histologically confirmed Grade 1-3a follicular lymphoma (FL), CD20-positive, with no evidence of histologic transformation
2. Ann Arbor Stage III/IV
3. No prior systemic therapy for FL
4. Meeting at least one of the GELF criteria for indicating treatment
5. FLIPI-1 or FLIPI-2 score of 3 to 5 (High risk)
* Cohort 2- Previously Untreated Low-Tumor-Burden FL：
1. Histologically confirmed Grade 1-3a, CD20-positive, Stage III/IV FL with no prior systemic therapy.
2. Absence of B symptoms or severe pruritus
3. Low tumor burden (LTB) not meeting GELF criteria for treatment
4. Must have at least one measurable lesion (longest diameter \>1.5 cm)
5. Patients who are suffering from the disease or prefer active management over a watch-and-wait approach
* Cohort 3-Relapsed or Refractory FL：
1. Histologically confirmed Grade 1-3a, CD20-positive, Stage III/IV FL with no evidence of histologic transformation.、
2. Relapsed or refractory disease, having received at least 1 prior systemic therapy regimen containing an anti-CD20 antibody
3. No prior treatment with a CD20/CD3 bispecific antibody or an EZH2 inhibitor
4. Presence of at least one measurable or evaluable lesion at relapse
