Status:
NOT_YET_RECRUITING
CT103d for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Relapsed/Refractory Multiple Myeloma (RRMM)
Plasma Cell Leukemia (PCL)
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This study is a single-center, open-label, dose-exploration trial designed to evaluate the tolerability and safety of different doses of CT103d in patients with relapsed/refractory plasma cell neoplas...
Detailed Description
This study adopts a "3+3" dose-escalation design, with three predefined dose levels: 0.5×10⁶ CAR-T cells/kg, 1.0×10⁶ CAR-T cells/kg, and 3.0×10⁶ CAR-T cells/kg, administered as a single infusion.For e...
Eligibility Criteria
Inclusion
- Age 18-75 years, any gender.
- Diagnosis of multiple myeloma (MM) per International Myeloma Working Group (IMWG) diagnostic criteria.
- Prior therapy requirements:
- MM patients: ≥3 prior lines of therapy, including:
- 1 proteasome inhibitor (PI)
- 1 immunomodulatory drug (IMiD)
- 1 anti-CD38 monoclonal antibody Exception: No minimum line requirement for subjects refractory to PIs, IMiDs, and anti-CD38 therapy.
- Primary plasma cell leukemia (pPCL): ≥1 prior line including ≥1 PI and ≥1 IMiD.
- Documented disease progression during/within 12 months after last anti-myeloma therapy (exemption: No 12-month requirement if last line was CAR-T).
- Measurable disease at screening (≥1 of the following):
- Serum M-protein:
- IgG ≥10 g/L IgA/IgD/IgE/IgM ≥5 g/L Urine M-protein ≥200 mg/24h Serum free light chains (FLC): Involved FLC ≥100 mg/L with abnormal κ/λ ratio Bone marrow plasma cells ≥30% (if no measurable M-protein/FLC).
- ECOG performance status 0-1.
- Life expectancy ≥12 weeks.
- Adequate organ function (all lab values within 7 days prior to enrollment):
- Hematology:
- Absolute neutrophil count (ANC) ≥1×10⁹/L (allowed: growth factor support, but none within 7 days) Absolute lymphocyte count (ALC) ≥0.3×10⁹/L Platelets ≥50×10⁹/L (no transfusion within 7 days) Hemoglobin ≥60 g/L (no RBC transfusion within 7 days; erythropoietin allowed)
- Liver:
- ALT/AST ≤2.5×ULN Total bilirubin ≤1.5×ULN Renal: Calculated CrCl ≥40 mL/min (Cockcroft-Gault)
- Coagulation:
- Fibrinogen ≥1.0 g/L aPTT/PT ≤1.5×ULN Pulmonary: SpO₂ \>91% (room air) Cardiac: LVEF ≥50% (echocardiography).
- Contraception: Subjects/partners must use effective contraception from consent through 1 year post CAR-T infusion (excluded: calendar method).
- Signed informed consent approved by the Ethics Committee prior to screening.
Exclusion
- Active graft-versus-host disease (GVHD) or requiring long-term immunosuppressive therapy.
- Prior hematopoietic stem cell transplantation (HSCT):
- Autologous HSCT (Auto-HSCT) within 12 weeks before apheresis,
- ≥2 prior Auto-HSCTs, Any prior allogeneic HSCT (Allo-HSCT).
- Prior cell therapy targeting plasma cells within 3 months before apheresis, or detectable residual cellular therapy products in peripheral blood.
- Recent anti-myeloma therapies (relative to apheresis):
- Monoclonal antibody treatment within 21 days, Cytotoxic chemotherapy or proteasome inhibitors within 14 days, Immunomodulatory drugs within 7 days, Other anti-tumor therapies within 14 days or 5 half-lives (whichever is shorter).
- Chronic corticosteroid use (\>20 mg/day prednisone or equivalent), except for physiologic replacement, topical, or inhaled use.
- Uncontrolled hypertension despite medication.
- Severe cardiac disease, including:
- Unstable angina, Myocardial infarction (within 6 months before screening), Congestive heart failure (NYHA Class ≥III), Severe arrhythmias.
- Unstable systemic illnesses per investigator's judgment (e.g., severe hepatic, renal, or metabolic disorders requiring medication).
- Other malignancies within 5 years, excluding:
- Carcinoma in situ of the cervix, Basal/squamous cell skin cancer, Localized prostate cancer post-radical resection, Ductal breast carcinoma in situ post-resection.
- History of solid organ transplantation.
- Suspected or confirmed CNS involvement by plasma cell neoplasms.
- Major surgery within 2 weeks before apheresis or planned within 2 weeks post-treatment (allowed: minor procedures under local anesthesia).
- Investigational drugs within 1 month before apheresis.
- Uncontrolled active infections:
- Persistent symptoms despite appropriate therapy, Requiring IV antimicrobials at screening.
- Viral infections:
- HBV: HBsAg(+) or HBcAb(+) with detectable HBV DNA, HCV: HCV Ab(+) with detectable HCV RNA, HIV Ab(+), CMV DNA(+), Syphilis: TRUST(+) and TPPA(+).
- Pregnancy or lactation.
- Psychiatric disorders, cognitive impairment, or active CNS diseases.
- Other conditions deemed ineligible by the investigator.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07185490
Start Date
September 15 2025
End Date
August 15 2029
Last Update
September 22 2025
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