Efficacy and Safety Evaluation of PD1-BCMA-CART

Bioray Laboratories

Status

Not yet enrolling

Conditions

Multiple Myeloma

Treatments

Biological: PD1-BCMA-CART

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05308875

2021-BRL-202

Details and patient eligibility

About

This trial aims to evaluate the safety and efficacy of PD1-BCMA-CART in treating patients with relapsed or refractory multiple myeloma.

Full 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.

Enrollment

9 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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