Status:
UNKNOWN
Efficacy and Safety Evaluation of PD1-BCMA-CART
Lead Sponsor:
Bioray Laboratories
Collaborating Sponsors:
The First Affiliated Hospital of Zhengzhou University
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This trial aims to evaluate the safety and efficacy of PD1-BCMA-CART in treating patients with relapsed or refractory multiple myeloma.
Detailed Description
Using gene editing, chimeric antigen receptors recognizing BCMA were integrated into subject self-derived T cells to obtain a large number of BCMA-CART by in vitro amplification, and BCMA-CART back in...
Eligibility Criteria
Inclusion
- Have the capacity to give informed consent;
- Confirmed diagnosis of active MM as defined by NCCN and IMWG criteria;
- Have a diagnosis of BCMA+ multiple myeloma (MM), (≥ 5% BCMA+ in CD138+ plasma cells by flow cytometry obtained within 45 days of study enrollment);
- Refractory and relapsed MM patients after \> 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (ASCT);
- ECOG score=0-2.
- Subjects according with any of the following options:
- Age≥50;
- Failure with separation of T cells during autologous CART processing; or,
- Failure with expansion of autologous CART; or,
- The proportion of T cells in PBMC \<10%; or,
- Won't benefit from autologous CART therapy because of disease progress.
Exclusion
- Pregnant or nursing women; Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy
- Active infection, HIV infection, syphilis serology reaction positive;
- Active hepatitis B, hepatitis C at the time of screening
- Significant hepatic dysfunction as following, SGOT(serum glutamic-oxaloacetic transaminase)\> 5 x upper limit of normal; bilirubin \> 3.0 mg/dL;
- Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis
- serious mental disorder;
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- Participate in other clinical research in the past three months; previously treatment with any gene therapy products
- Contraindication to cyclophosphamide or fludarabine chemotherapy
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05308875
Start Date
March 1 2024
End Date
October 1 2025
Last Update
January 5 2024
Active Locations (1)
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1
First Affliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052