Status:
NOT_YET_RECRUITING
Exploratory Clinical Study on the Safety and Efficacy of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Myeloid Malignancies
Lead Sponsor:
Tongji Hospital
Collaborating Sponsors:
Hebei Taihe Chunyu Biotechnology Co., Ltd
Conditions:
Myeloid Malignancies
CAR-T
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, single-arm, exploratory clinical trial utilizing a "3+3" dose escalation followed by dose expansion to evaluate the safety, maximum tolerated dose (MTD), pharmacokinetics (PK), ...
Eligibility Criteria
Inclusion
- Informed Consent: Willing and able to provide written informed consent, with commitment to comply with scheduled visits, study treatment, laboratory tests, and other trial procedures.
- Age: ≥18 years, regardless of gender.
- Diagnosis: Pathologically confirmed myeloid malignancy (including but not limited to AML or MDS) meeting relapsed/refractory criteria:
- Relapsed Disease: Reappearance of leukemic cells in peripheral blood, bone marrow blasts \>5%, or extramedullary relapse after achieving CR/CRi with ≥2 lines of salvage therapy.
- Refractory Disease: Failure to achieve CR/CRi after ≥2 cycles of standard intensive chemotherapy.
- Antigen Expression: Tumor cell positivity for CD33, CD123, and/or CLL-1 confirmed by immunohistochemistry (IHC) or flow cytometry.
- Life Expectancy: ≥3 months from the date of informed consent signing. Hematologic Criteria: Hemoglobin ≥70 g/L (transfusion permitted).
- Organ Function:
- Renal: Serum creatinine ≤1.5×ULN. Cardiac: Left ventricular ejection fraction (LVEF) ≥50%. Pulmonary: Oxygen saturation \>90% on room air. Hepatic: Total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
Exclusion
- Cardiac Dysfunction: Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) \<50%.
- Pulmonary Disease: History of severe pulmonary dysfunction (e.g., chronic respiratory failure, interstitial lung disease, or pulmonary hypertension requiring oxygen therapy).
- Concurrent Malignancy: Active/progressive malignancy other than myeloid neoplasms (exceptions: adequately treated non-melanoma skin cancer or carcinoma in situ).
- Uncontrolled Infection: Active severe infection requiring systemic antimicrobial therapy (antibacterial, antiviral, or antifungal) without clinical resolution.
- Immune Disorders:
- Severe autoimmune disease requiring immunosuppressive therapy within 6 months. Primary immunodeficiency disorders (e.g., common variable immunodeficiency, severe combined immunodeficiency).
- Viral Infections:
- Active hepatitis B (HBV-DNA ≥2000 IU/mL) or hepatitis C (HCV-RNA positive). HIV infection, AIDS, or untreated syphilis (confirmed by serological testing). Hypersensitivity: History of severe allergic reaction (Grade ≥3) to biological products, including antibiotics.
- Transplant Complications: Allogeneic hematopoietic stem cell transplant recipients with:
- Acute graft-versus-host disease (GvHD) ≥ Grade II within 3 months. Ongoing immunosuppressive therapy for GvHD within 4 weeks.
- General Exclusion:
- Any physical, psychiatric, or laboratory abnormality that may:
- Significantly increase study risk (e.g., uncontrolled diabetes, NYHA Class III/IV heart failure).
- Compromise protocol compliance or data interpretation. Investigator-determined unsuitability for trial participation.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06917105
Start Date
April 1 2025
End Date
April 30 2029
Last Update
April 8 2025
Active Locations (1)
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1
Tongji Hospital affiliated to Tongji Medical College of Huazhong University
Wuhan, Hubei, China, 430030