Clinical Study to Evaluate the Safety and Feasibility of Targeting CD269 Chimeric Antigen Receptor Engineered T Cell (spCART-269) Injection in the Treatment of CD269-positive Multiple Myeloma

Shanghai Tongji Hospital, Tongji University School of Medicine1 site in 1 country10 target enrollmentJuly 1, 2018

ConditionsMultiple Myeloma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Multiple Myeloma
Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Enrollment: 10
Locations: 1
Primary Endpoint: Occurrence of study related adverse events
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of spCART-269 in treatment of relapsed or refractory multiple myeloma patients.

Detailed Description

This study plans to enroll 10 patients to assess the safety and efficacy of spCART-269. Subjects who meet the eligibility criteria will receive a single dose of spCART-269 injection. The study will include the following sequential phases: Screening, Pre-treatment (Cell product preparation; Lymphodepleting Chemotherapy), Treatment and follow-up.

Registry

clinicaltrials.gov

Start Date

July 1, 2018

End Date

December 1, 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Tongji Hospital, Tongji University School of Medicine

Responsible Party

Principal Investigator

Aibin Liang，MD，Ph.D.

Vice President of Tongji Hospital

Shanghai Tongji Hospital, Tongji University School of Medicine

Eligibility Criteria

Inclusion Criteria

•The patient was diagnosed as active MM according to the diagnostic criteria of the International Myeloma Working Group (IMWG)
•The patient meets any of the following:
•Have received at least 3 treatment options in the past and include alkylating agents, proteasome inhibitors and immunomodulators;
•If the patient has received a regimen containing proteasome inhibitor and immunomodulator for at least 2 courses, and the effect is not good (such as disease progression within 60 days of treatment)
•Voluntary participation in clinical research and signing informed consent
•Age 18-65, regardless of gender
•Expected survival time is greater than 12 weeks
•If the patient has received autologous hematopoietic stem cell transplantation in the past, a 90-day interval is required
•Normal bone marrow hematopoietic function, blood routine: hemoglobin ≥ 100 g/L; absolute neutrophil ≥ 1.5×10\^9/L; platelet count ≥ 100×10\^9/L
•Liver function: serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 (ULN) times the upper limit of normal value (if abnormal liver function is mainly caused by tumor infiltration, it can be ≤ 5 times the upper limit of normal value (ULN) )), bilirubin \<2.0 mg/dL

Exclusion Criteria

•ECOG score ≥ 3 points
•Female patients during pregnancy or lactation
•Pathological examination revealed malignant tumor cells with T cell origin
•Organ failure: Heart failure grade Ⅲ and Ⅳ; liver reaches Child-Turcotte liver function grade C; renal failure and uremia; respiratory failure; consciousness disorder
•Patients with acute or chronic GVHD after allogeneic hematopoietic transplantation, or using hormones or immunosuppressants within 30 days
•Patients with HIV infection or active hepatitis
•There are other uncontrolled active infections
•Those who may be allergic to cytokines
•Those who have used any gene therapy products
•Those who participated in other clinical studies 4 weeks before enrollment (except those who did not receive treatment in clinical studies)