Clinical Study to Evaluate the Safety and Feasibility of spCART-269 Injection in the Treatment of MM

NCT04500431 | Unknown Phase 1

• 1 other identifier: 200802
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Occurrence of study related adverse events

  Incidence and severity of Treatment emergent adverse events

  12 weeks

Secondary Outcomes (4)

• Overall response rate (ORR)

  12 months

• Duration of remission (DOR)

  12 months

• Progression free survival (PFS)

  12 months

• Overall survival (OS)

  12 weeks, 6 months, 12 months

Study Arms (1)

spCART-269

EXPERIMENTAL

spCART-269 administered by intravenous (IV) infusion

Biological: Targeting CD269 chimeric antigen receptor engineered T cells

Interventions

Targeting CD269 chimeric antigen receptor engineered T cells BIOLOGICAL

Targeting CD269 chimeric antigen receptor engineered T cells, single infusion intravenously

Also known as: spCART-269

spCART-269

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Tongji Hospital, Tongji University School of Medicine: lead

Study Sites (1)

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200065, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Aibin Liang, MD, Ph.D

  Shanghai Tongji Hospital, Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aibin Liang, MD, Ph.D

CONTACT

0086-021-66111019; lab7182@tongji.edu.cn

Ping Li, MD,Ph.D.

CONTACT

0086-021-66111015; lilyforever76@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Tongji Hospital

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 5, 2020
• Study Start: July 1, 2018
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)