A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma

NCT04295018 | Unknown Phase 1

• 1 other identifier: 0203-007
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, non-randomized study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patients.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• The Incidence of adverse events (TEAEs) within 30 days after intravenous infusion of C-CAR088

  30 days

Secondary Outcomes (2)

• Overall response rate (ORR)

  12 months

• Progression free survival (PFS)

  6 months#12 months

Study Arms (1)

C-CAR088

EXPERIMENTAL

Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene

Drug: C-CAR088

Interventions

C-CAR088 DRUG

Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10\^6 anti-BCMA CAR+T cells/kg. Other Name: CBM.BCMA Chimeric Antigen Receptor T cell.

C-CAR088

Eligibility Criteria

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

You may qualify if:

• Age 18-75 years old, male or female;
• The patient volunteered to participate in the study, and he or his legal guardian signed the Informed Consent;
• Patients with a clear diagnosis of relapsed or refractory multiple myeloma
• The patient have one or more measurable multiple myeloma lesion, must include one of the following conditions:
• Serum M protein≥1.0 g/dL(10g/L)
• Urine M protein≥200 mg/24h
• Serum free light chain(sFLC): κ/λ FLC ratio is abnormal and affected FLC ≥10mg / dL
• Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination;
• At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.
• ECOG scores 0 - 1;
• Good cardiac and pulmonary organ function;
• Expected survival time \> 12 weeks;.
• Female subjects of childbearing age must have a negative urine / blood pregnancy test within 7 days before cell therapy and not be in lactation; female or male subjects of childbearing age need to take effective contraception throughout the study.

You may not qualify if:

• Have a history of allergy to cellular products;
• Laboratory testing occurs when: including but not limited to, serum total bilirubin ≥1.5mg / dl; serum ALT or AST is 2.5 times higher than the upper limit of normal value; serum creatinine ≥2.0mg / dl; hemoglobin \<80g / L; absolute neutrophil count \<1000 / mm3 or dependent on GCSF or Other growth factors can maintain the centriole count ≥1000 / mm²; platelet count \<50000 / mm³ or the above level can be maintained due to platelet transfusion;
• Presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart function Grade 3 (moderate) or Grade 4 (severe) heart disease (according to the New York Heart Association Function Classification method: NYHA); patients with a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris or other clinically significant heart disease within 12 months before enrollment;
• A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease;
• Need to use any anticoagulant (except aspirin);
• Patients requiring urgent treatment due to tumor progression or spinal cord compression;
• Patients with CNS metastasis or symptoms of CNS involvement;
• After allogeneic hematopoietic stem cell transplantation;
• Plasma cell leukemia;
• Patients with autoimmune diseases, immunodeficiency, or other immunosuppressive agents;
• Uncontrolled active infection;
• Have used any CAR T cell products or other genetically modified T cell therapy before;
• Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons;
• Have a history of alcoholism, drug addiction and mental illness;
• Participated in any other clinical trial within 1 months;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Shanghai AbelZeta Ltd.: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

Related Publications (1)

• Qu X, An G, Sui W, Wang T, Zhang X, Yang J, Zhang Y, Zhang L, Zhu D, Huang J, Zhu S, Yao X, Li J, Zheng C, Zhu K, Wei Y, Lv X, Lan L, Yao Y, Zhou D, Lu P, Qiu L, Li J. Phase 1 study of C-CAR088, a novel humanized anti-BCMA CAR T-cell therapy in relapsed/refractory multiple myeloma. J Immunother Cancer. 2022 Sep;10(9):e005145. doi: 10.1136/jitc-2022-005145.

  PMID: 36100310 DERIVED

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

• Daobin Zhou

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daobin Zhou, PhD&MD

CONTACT

010-69155020; zhoudb@pumch.cn

Lu Zhang

CONTACT

010-69155660; pumczhanglu@163.com

Study Design

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

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: October 23, 2019
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 4, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)