A Study of Fully Human BCMA CAR-T (CT103A) in Patients With Newly Diagnosed High-risk Multiple Myeloma (FUMANBA-2)

NCT05181501 | Not Yet Recruiting Phase 1

• 1 other identifier: CT103ACI001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

This study is a multi-center, single-arm clinical study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamic characteristics of CT103A as the first-line treatment in newly diagnosed high-risk multiple myeloma subjects with induction chemotherapy as bridging therapy.

Conditions

Multiple Myeloma

Keywords

newly diagnosed; multiple myeloma; treatment naive; CAR-T

Outcome Measures

Primary Outcomes (2)

• Proportion of Minimal Residual Disease (MRD)-negative subjects

  The proportion of subjects who achieve MRD-negativity after CT103A infusion.

  Up to 2 years after CT103A infusion

• Median progression-free survival (mPFS)

  The median time from the date of CT103A infusion to the date of first disease progression or death from any cause.

  Up to 2 years after CT103A infusion

Secondary Outcomes (10)

• Best overall response (BOR)

  Up to 2 years after CT103A infusion

• Median survival (mOS)

  Up to 2 years after CT103A infusion

• Event-free survival (EFS)

  Up to 2 years after CT103A infusion

• Duration of response (DOR)

  Up to 2 years after CT103A infusion

• Safety endpoint

  Up to 2 years after CT103A infusion

Study Arms (1)

CT103A in Newly Diagnosed Subjects With High-risk Multiple Myeloma

EXPERIMENTAL

Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection（CT103A）will be infused at 1.0 x 10\^6 CAR+ T cells/kg in newly diagnosed subjects with high-risk multiple myeloma

Drug: Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)

Interventions

Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A) DRUG

CT103A is a customized, BCMA-targeted genetically modified autologous T cell immunotherapy, which can identify and eliminate malignant and normal cells expressing BCMA. CAR specifically recognizes BCMA with single chain fragment variable (ScFv), and promotes the activation, proliferation, cytokine secretion and target cell killing of CAR-T through the CD3ζ domain. And 4-1BB enhances the expansion and persistence of CT103A. CT103A will be infused at 1.0×10\^6 /kg via intravenous drip within 24h to 72h after chemotherapy conditioning regimen at the recommended infusion rate of 3-5 mL/min.

Also known as: CT103A

CT103A in Newly Diagnosed Subjects With High-risk Multiple Myeloma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years old, male or female;
• Newly diagnosed as high-risk multiple myeloma:
• Revised Multiple Myeloma International Staging System (R-ISS) stage 3;
• Double-hit or triple-hit according to FISH test.
• Presence of measurable lesions during screening according to any of the following criteria:
• The proportion of primitive naive or monoclonal plasma cells ≥ 5% by bone marrow cytology, bone marrow biopsy histology or flow cytometry;
• Serum monoclonal protein (M-protein) level: M protein ≥10 g/L for IgG type, M protein ≥5g/L for IgA, IgD, IgM, and IgE type;
• Urine M protein level ≥200 mg/24 hours;
• Light chain multiple myeloma without measurable lesions in serum or urine: the affected serum free light chain ≥100 mg/L with abnormal serum κ/λ free light chain ratio;
• ECOG score of 0 or 1;
• Expected survival time ≥ 12 weeks;
• Subjects must have appropriate organ functions and meet all the following laboratory test requirements before enrollment:
• Hematology: Absolute neutrophil count (ANC) ≥ 1×10\^9/L (prior growth factor support is allowed, but supportive treatment within 7 days before laboratory test is not allowed); Absolute lymphocyte count (ALC) )≥0.3×10\^9/L; platelets≥75×10\^9/L (blood transfusion support within 7 days before laboratory test is not allowed); hemoglobin ≥60 g/L (without red blood cell \[RBC\] transfusion within 7 days before laboratory test; recombinant human erythropoietin is allowed);
• Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×upper limit of normal (ULN); serum total bilirubin≤1.5×ULN;
• Renal function: creatinine clearance calculated according to Cockcroft-Gault formula≥ 40 ml/min.

You may not qualify if:

• Patient who needs chronic use of immunosuppressive agents;
• Patient with hypertension that cannot be controlled by medication;
• Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association \[NYHA\] classification ≥ grade III), severe arrhythmia;
• Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases that require drug treatment;
• Patients with malignant tumors other than multiple myeloma within 5 years before screening, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and those after radical resection Ductal carcinoma in situ of breast;
• Patient with a history of solid organ transplantation;
• Patient who is suspected with or with symptoms of central nervous system invasion by plasma cell tumors;
• Multiple myeloma patients with plasma cell leukemia;
• Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and detectable hepatitis B virus (HBV) DNA in peripheral blood; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus ( HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA test positive; syphilis test positive;
• Women who are pregnant or breastfeeding;
• Patient with mental illness or disturbance of consciousness or central nervous system disease;
• Major surgery history within 2 weeks before entering the study, or scheduled surgery during the study period or within 2 weeks after the study treatment;
• Other situations considered unsuitable by the investigator.

Sponsors & Collaborators

• Nanjing IASO Biotechnology Co., Ltd.: lead

Study Sites (4)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Location

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

CT103A chimeric antigen receptor

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

• Lijuan Chen, M.D.

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Bing Chen, M.D.

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lijuan Chen, M.D.

CONTACT

025-68306091; chenljb@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: January 6, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2024
• Study Completion (Estimated): April 1, 2039
• Last Updated: January 6, 2022

Record last verified: 2022-01

Locations

CN (4)