Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 80

Testing FD-001 for recurrent or refractory blood cancers

Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of FD-001 in Patients with Relapsed or Refractory Hematological Malignancies.

Run by Chengdu FenDi Pharmaceutical Co., Ltd. · NCT06731699 · Data updated 2026-11-12

This study is testing a new medication called FD-001 to see if it can help people with tough-to-treat blood cancers like acute myeloid leukemia and non-Hodgkin lymphoma.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment72 (estimated)
SponsorChengdu FenDi Pharmaceutical Co., Ltd.
Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations1 site (Chengdu, Sichuan)
StatusRecruiting
StartedMarch 11, 2024
Main results expectedJanuary 24, 2026
Study endsMarch 1, 2026
Registry record updatedDecember 17, 2024
Trial IDNCT06731699 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 80 with recurrent or refractory hematologic malignancies who have failed standard treatments.

Probably not a fit

Patients with hematologic malignancies that are not recurrent or refractory, or those who have not failed standard treatments, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 clinical trial that evaluates the safety, tolerability, and preliminary efficacy of FD-001 capsules in patients with recurrent or refractory hematologic malignancies, including acute myeloid leukemia (AML) and non-Hodgkin lymphoma (NHL). The trial consists of a dose-escalation phase to determine the maximum tolerated dose and a dose-expansion phase for further assessment. Participants will undergo a screening period followed by treatment and follow-up phases, with blood samples collected for pharmacokinetic studies.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat blood cancers.

How similar studies have gone: Other studies have shown promise with similar investigational therapies in treating hematologic malignancies, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • West China Hospital of Sichuan University
    Chengdu, Sichuan, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • 6MW5311 in adults with relapsed or refractory blood cancers

    This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.

    Recruiting Phase 1 Mabwell (Shanghai) Bioscience Co., Ltd. · Shanghai, Shanghai Municipality · NCT07914556

  • CRD3874-SI in People with Leukemia

    A small early-stage study tests CRD3874-SI to see if it is safe for adults with relapsed or refractory acute myeloid leukemia.

    Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07661095

  • Allogeneic CAR-T CT0890B for relapsed/refractory AML

    This study tests whether a universal CAR-T cell therapy called CT0890B is safe and potentially effective for adults with relapsed or refractory acute myeloid leukemia who express NKG2D ligands.

    Recruiting Phase 1 Peking University People's Hospital · Beijing · NCT07617285

  • Biomarkers in Bone Marrow to Predict AML Chemosensitivity

    This study tests whether markers in bone marrow can predict how adults with AML will respond to chemotherapy.

    Recruiting Fujian Medical University Union Hospital · Fuzhou, Fujian · NCT07587944

  • Azacitidine plus venetoclax maintenance vs azacitidine alone in AML

    This trial tests whether adding venetoclax to azacitidine maintenance helps people with AML stay disease-free after achieving first remission.

    Recruiting Phase 3 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07539818

  • Azacitidine with APG1252 in high-risk AML (Phase 1b/2)

    This study tests whether adding APG1252 to azacitidine is safe and helps some patients with high-risk AML feel better or respond to treatment.

    Recruiting Phase 1/2 M.D. Anderson Cancer Center · Houston, Texas · NCT07508982

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Browse more
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.