A Phase 1 Study of FD-001 in Recurrent /Refractory (R/R)AML/NHL/MM/MDS

Launched by CHENGDU FENDI PHARMACEUTICAL CO., LTD. · Dec 9, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called FD-001 to see how safe it is and how well it works for patients with certain types of blood cancers, specifically acute myeloid leukemia (AML) and non-Hodgkin lymphoma (NHL) that have not responded to previous treatments. The study is divided into two parts: an initial phase where researchers will gradually increase the dose to find the highest amount that can be given safely, and a later phase that will further explore the effects at that dose. The main goal is to determine the safety of FD-001 and establish a recommended dose for future studies.

To participate in this trial, you need to be between 18 and 80 years old and have a confirmed diagnosis of AML or NHL that hasn't improved with standard treatments. You should also be in decent overall health, meaning you can perform daily activities with some limitations. Patients join this trial voluntarily, and they can expect to undergo regular health check-ups to monitor their response to the treatment and any potential side effects. It's important to know that this study is currently recruiting participants, and if you're interested, you should talk to your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Willing to voluntarily participate in this clinical study; possess a comprehensive understanding of, provide consent for, and sign the written informed consent form (ICF) for this study; demonstrate willingness to adhere to and complete all study procedures.
• • 2. Age range from 18 to 80 years (inclusive), with no gender restrictions.
• • 3. ECOG performance status ≤2 (refer to Appendix 1).
• • 4. Expected minimum survival period of at least 3 months.
• • 5. Patients diagnosed with hematological malignancies confirmed through pathological and/or cytological examinations, who have either failed or not received standard treatment due to lack of efficacy or intolerance. This includes patients with recurrent/refractory conditions.
• 6. Presence of at least one measurable lesion:
• • For AML: bone marrow containing more than 5% primitive/immature cells (excluding regeneration after consolidation chemotherapy).
• • For MDS: bone marrow aspirate or biopsy pathological examination revealing less than 20% primitive cells.
• * For MM: meeting any of the following criteria:
• • 1. Monoclonal protein detected in blood ≥1 g/dL (10g/L) through serum protein electrophoresis.
• • 2. Urine monoclonal protein ≥200 mg over a span of 24 hours.
• • 3. If monoclonal protein is undetectable in blood or urine, affected-to-unaffected serum FLC ratio should be ≥100 (with affected serum FLC level being ≥100 mg/L).
• • For NHL: presence of measurable lesions identified by CT, PET-CT, or PET-MRI scans such as lymph node lesions with major axis \>1.5 cm or extranodal lesions with major axis \>1.0 cm); CLL/SLL: peripheral blood monoclonal lymphocytes ≥5.0×10\^9/L; WM: IgM \>2×ULN.
• • 7. Adverse effects resulting from previous anti-cancer therapy should have recovered to grade ≤1 (continuous hair loss excluded along with laboratory tests specified in criterion 8).
• 8. With sufficient organ function support, all the following criteria must be met during the laboratory tests in the screening period:
• • The white blood cell (WBC) count should be less than or equal to 30×10\^9/L before the first use of the investigational drug; (This criterion is only applicable to AML and MDS, and the use of hydroxyurea to lower the white blood cell count is permitted.) The absolute neutrophil count (ANC) should be greater than or equal to 1.0×10\^9/L before the first use of the investigational drug, and it can be relaxed to 0.75×10\^9/L in the case of bone marrow infiltration; the platelet count (PLT) should be greater than or equal to 70×10\^9/L before the first use of the investigational drug, and it can be relaxed to 50×10\^9/L in the case of bone marrow infiltration; the hemoglobin (HB) level should be greater than or equal to 70 g/L before the first use of the investigational drug, and it can be relaxed to 60 g/L in the case of bone marrow infiltration (This criterion is only applicable to MM and NHL; It is required that this test was not conducted within 7 days before blood collection after the administration of G-CSF (or GM-CSF), erythropoietin, thrombopoietin treatment or component blood transfusion)
• Exclusion Criteria:
• • 1. Within 4 weeks prior to the first dose of the study drug or within 5 half-lives (whichever is shorter), the subject has received anti-cancer therapy, including chemotherapy, immunotherapy, targeted therapy (excluding hydroxyurea therapy and prophylactic intrathecal injection of chemotherapy drugs); received radiation therapy within 2 weeks; received anti-cancer therapy with Chinese herbal medicine within 2 weeks;
• • 2. Chronic myeloid leukemia (CML) with BCR/ABL positivity;
• • 3. The subject has central nervous system malignant tumor infiltration;
• • 4. The subject has another malignant tumor at the same time (excluding IB stage or lower-stage cervical cancer that has been cured, non-invasive basal cell or squamous cell skin cancer, and other malignant tumors that have achieved complete remission (CR) \>10 years and \>5 years, respectively);
• • 5. Within 4 weeks prior to the first dose of the study drug, the subject has received an active or attenuated live vaccine;
• • 6. The subject has a history of clear alcohol and drug abuse; a history of severe allergies in the past, or is allergic to any component of the study drug.