Actively Recruiting
Clinical Study on the Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation Combined With BCMA-CAR-T in the Treatment of Ultra-high Risk Multiple Myeloma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-07
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
H
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining autologous hematopoietic stem cell transplantation (ASCT) with BCMA CAR-T cell therapy to treat patients with ultra-high risk multiple myeloma (UHR-MM). This prospective, single-center clinical study focuses on patients aged 18 to 70 years who meet specific high-risk criteria related to their multiple myeloma condition. The study is designed to explore how this combination treatment works in this challenging patient group. Participants receive autologous hematopoietic stem cell transplantation followed by reinfusion of BCMA-CAR-T cells at a dose of 1.0 to 2.0 million CAR-T cells per kg body weight, administered around day 3 after stem cell infusion. This approach is being studied to understand the combined impact of these treatments. The study includes closely monitored treatment and follow-up periods to assess patient responses and safety. During the study, participants will undergo evaluations including blood tests, organ function assessments, and disease monitoring to track treatment effects and safety. The primary outcome measure is the rate of minimal residual disease (MRD) negativity three months after treatment. Participants will be followed for safety and efficacy outcomes, with careful monitoring throughout the trial duration. The total participation time depends on the study timeline, which extends through several months after treatment.
CONDITIONS
Brief Title
Autologous Transplantation Combined With BCMA CAR-T in the Treatment of UHR-MM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with ultra high risk multiple myeloma (UHR-MM), aged 18 to 70 years, and suitable for autologous stem cell transplantation (ASCT).
- Meet any of the following UHR-MM definitions: cytogenetic ultra-high risk features, primary refractory disease, early progression, plasma cell leukemia, non paraosseous extramedullary infiltration, or R2-ISS-IV / MPSS-IV classification.
- Voluntary participation with signed informed consent.
- Proper organ function including serum total bilirubin ≤ 1.5 times upper limit of normal (ULN), ALT and AST ≤ 2.5 × ULN, creatinine clearance ≥ 40 ml/min, coagulation times within specified limits.
- Hemoglobin ≥ 60 g/L, absolute neutrophil count ≥ 1.0 × 10⁹/L, absolute lymphocyte count ≥ 0.5 × 10⁹/L, platelet count ≥ 50 × 10⁹/L.
- Left ventricular ejection fraction (LVEF) ≥ 45%.
- Blood oxygen saturation (SpO2) ≥ 92%.
- ECOG performance status score of 0-1.
- Estimated survival of at least 3 months.
- Negative pregnancy test for fertile females and effective contraception for both females and males within 24 months after cell infusion.
You will not qualify if you...
- History of allergy to any component of the cell products.
- Serious heart disease such as recent myocardial infarction, unstable angina, severe arrhythmia, severe cardiomyopathy, or congestive heart failure NYHA class III or IV.
- Previous autologous or allogeneic hematopoietic stem cell transplantation.
- Stroke or seizure within 6 months before enrollment.
- Autoimmune disease, immune deficiency, or other conditions requiring immunosuppressant treatment.
- Malignant tumors other than multiple myeloma within the past 3 years, except certain treated cancers without recurrence.
- Active uncontrolled infections.
- Unstable systemic diseases including serious liver, kidney, or metabolic conditions requiring treatment.
- Recent positive tests for hepatitis B, hepatitis C, HIV, syphilis, or CMV infections before lymphocyte collection.
- Use of more than 5 mg/day prednisone or equivalent corticosteroids within 1 week before lymphocyte collection.
- Previous use of CAR-T cell products or other genetically modified T cell therapies.
- Prior BCMA-targeted therapy.
- History of live vaccination within 4 weeks before enrollment.
- History of alcohol or drug abuse or mental illness.
- Other conditions judged by researchers as unsuitable for participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Treatment period including stem cell transplantation and BCMA CAR-T infusion on day +3 (±1 day) after transplantation
Participants receive autologous hematopoietic stem cell transplantation followed by BCMA CAR-T cell infusion to treat ultra-high risk multiple myeloma.
Inpatient visits during transplantation and CAR-T infusion
Duration - Up to 3 months after treatment
Participants are monitored for safety and efficacy outcomes following treatment.
Regular follow-up visits over 3 months
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
D
Dehui Zou
Y
Yan Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here