Status:
UNKNOWN
Clinical Study to Evaluate the Safety and Feasibility of spCART-269 Injection in the Treatment of MM
Lead Sponsor:
Shanghai Tongji Hospital, Tongji University School of Medicine
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 myel...
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 in...
Eligibility Criteria
Inclusion
- 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
- Renal function: BUN is 9-20 mg/dL, serum creatinine ≤ 1.5 times the upper limit of normal (ULN), endogenous creatinine clearance rate ≥50 ml/min
- Serum virus EBV, CMV, HBV, HCV, HIV and syphilis antibodies are negative
- Heart function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 45%
- ECOG physical status score 0-2
- Possess apheresis or sufficient venous access for venous blood, and no other contraindications for leukocyte separation
- T cells can be successfully expanded in vitro
- Women of childbearing age who provide negative reports of pregnancy tests with serum or urine before reinfusion
- Adults with fertility requirements, regardless of sex, contraception within one year after treatment
Exclusion
- 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)
- Patients with systemic autoimmune diseases or immunodeficiency diseases
- Definite neuropathy or psychosis, including authors of dementia or epilepsy
- Those with lung or intestinal tumor infiltration
- Patients that other researchers think are not suitable for enrollment
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04500431
Start Date
July 1 2018
End Date
December 1 2022
Last Update
August 5 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China, 200065