Study of BCMA CAR-T in Multiple Myeloma

NCT03559764 | Unknown Early Phase 1

• 1 other identifier: BCMA CAR T-HNRM-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single centre、single arm、open-label，to investigate the safety and efficacy of anti-BCMA CAR T cells in patients with Relapsed and Refractory multiple myeloma.

Conditions

Relapsed and Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• The safety of CAR T is evaluated to determine if CRS occurred

  defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment

  Day 3-Year 2 after injection

Study Arms (1)

Anti-BCMA CAR T cells

EXPERIMENTAL

Total dose of 0.5-6 millions /kg cells will be administered at day -2, day -1 and day 0 by split dose (30%, 30% and 40% respectively).

Biological: Anti-BCMA CAR T cells

Interventions

Anti-BCMA CAR T cells BIOLOGICAL

Transparent colorless or slightly yellow liquid

Anti-BCMA CAR T cells

Eligibility Criteria

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

You may qualify if:

• Male or female, 18 to 70 years old (including 18 and 70 years old)
• BCMA antigen diagnosed by pathology and histological examination was positive
• ECOG ≤2，and the excepted survival ≥ 3 months
• Patients with BCMA+ myeloma who received ≥ 1 line of chemoradiotherapy or tumor relapsed
• The main organs function is good; （1） liver function: ALT/AST\<3 times normal value upper limit (ULN) and total bilirubin \<34.2 (mol/L); （2） renal function: creatinine \<220 mu /L,GFR \> 30mL/min; （3） lung function: blood oxygen saturation is greater than 95%; （4） cardiac function: left ventricular ejection fraction (LVEF) is greater than 50%;
• Platelets \> 40 billion/L;
• Patients without any anti-cancer treatment such as chemotherapy，radiotherapy, immunotherapy（ immunosuppressive drugs ）within 2-4 weeks before, and the treatment-related toxicity reaction ≤1 level prior to enrollment（except low toxicity lose hair for example）
• Venous channel is unobstructed, which can meet the needs of intravenous drip;
• Voluntary informed consent is given, agree to follow the trial treatment and visit plan.

You may not qualify if:

• Patients with allergy to large molecules such as antibodies or cytokines;
• More than 5mg of hormones (except patients with inhaled hormone) were used within 2 to 4 weeks prior enrollment;
• Patients with severe autoimmune diseases or immunodeficiency diseases;
• Patients treated with other immune cellular products (DC, CIK, T, NK, and CART products with CD19 or other targets);
• Patients with uncontrollable infectious disease in the first 4 weeks of treatment;
• Active hepatitis B DNA \> 1000copy/mL/ , hepatitis C positive, (HCV positive resistance, HCV RNA positive);
• Patients participated in other clinical trials within 6 weeks prior enrollment;
• Patients with mental illness;
• Patients with drug abuse/addiction and medical, psychological or social conditions may interfere with the study or evaluate the results of the study;
• Patients have alcohol dependence;
• Pregnant or lactating women; Men or women who have a pregnancy plan within a year; The patients cannot guarantee effective contraceptive measures during the trial period;
• Patients had other conditions that were not appropriate for the group determined by the researchers.

Sponsors & Collaborators

• Allife Medical Science and Technology Co., Ltd.: lead

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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 Design

• Study Type: interventional
• Phase: early phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 18, 2018
• Study Start: June 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 18, 2018

Record last verified: 2018-06