Multiple Myeloma
Conditions
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 into the subjects could identify and kill myeloma cells in the subjects.This open-label, dose-escalation study was designed to evaluate the safety and antitumor efficacy of PD1-BCMA-CART in the treatment of relapsed or refractory multiple myeloma.
Interventions
BIOLOGICALPD1-BCMA-CART
Single infusion of PD1-BCMA-CART administered intravenously (i.v.)
Sponsors
The First Affiliated Hospital of Zhengzhou University
Bioray Laboratories
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
0.5-2×10\^6/kgBW
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Up to 90 days after T cell infusion | Proportion of patients in whom a response among complete response or partial response, as defined by International Myeloma Working group(IMWG) response criteria , will be observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability | Up to 35 days after T cell infusion | Adverse events assessed according to NCI-CTCAE v5.0 criteria |
| Duration of persistence of PD1-BCMA-CART | Baseline up to 2 year | Detect the duration of PD1-BCMA-CART after injection using FACS or Q-PCR |
Countries
China
Contacts
Primary Contactwei Li, PhD
Outcome results
None listed