Clinical trial NCT05308875: Efficacy and Safety Evaluation of PD1-BCMA-CART
Official title: Clinical Study of the Safety and Efficacy of Non-viral Site-directed Integrated PD1-BCMA-CART in Adult Treatment of Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Bioray Laboratories
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
First posted: 2022-04-04
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 0.5-2×10\^6/kgBW
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 90 days after T cell infusion
Secondary outcomes:
measure: Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 35 days after T cell infusion
measure: Duration of persistence of PD1-BCMA-CART
timeFrame: Baseline up to 2 year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: First Affliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: First Affliated Hospital of Zhengzhou University
name: Yi Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: