Clinical Trial to Evaluate CT053 in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 1)

NCT03975907 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: CT053-MM-01
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 23

Brief Summary

This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT053 CAR-BCMA T in patients with relapsed and/or refractory multiple myeloma.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; car-T

Outcome Measures

Primary Outcomes (2)

• Phase 1, Safety and tolerability: dose limiting toxicity

  dose limiting toxicity

  28days post administration of CAR-T-cells

• Phase 2, efficacy of CT053 CAR-BCMA T cells: overall response rate

  overall response rate (ORR)=（sCR+CR+VGPR+PR)

  3 months post administration of CAR-T-cells

Secondary Outcomes (19)

• Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion

  3 months post administration of CAR-T-cells

• Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion

  3 months post administration of CAR-T-cells

• Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion

  3 months post administration of CAR-T-cells

• Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion

  3 months post administration of CAR-T-cells

• Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion

  3 months post administration of CAR-T-cells

Study Arms (1)

CAR-BCMA T Cells

EXPERIMENTAL

Phase I: The subjects are enrolled into 2 dose level cohorts in sequence. Phase II: Single arm

Biological: CAR-BCMA T Cells

Interventions

CAR-BCMA T Cells BIOLOGICAL

The CAR-BCMA T cells (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting BCMA.

CAR-BCMA T Cells

Eligibility Criteria

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

You may qualify if:

• Patients and legally acceptable representative must have voluntarily signed ICF and willing to complete the study procedure, after fully understanding of the study.
• Age ≥ 18 years and ≤ 75 years, male or female
• The patients have received at least 3 prior lines for MM, (Induction therapy followed by autologous transplantation\[ASCT\] and maintenance therapy represents one line of therapy, those who have not been treated with ASCT should have documented rationale); For each line of therapy, the patient should have received at least one standard treatment cycle (2016 IMWG) unless the best response to the treatment line is documented as progressive diseases (PD)
• The patients should have received treatment with at least one proteasome inhibitor AND one immunomodulatory drug, and have ever been relapsed or deteriorated after treatment with at least one regimen consisting of above-mentioned medications (combination or single use)；
• Patient should be relapsed within 12 months after the last line of therapy, or disease progressed within 60 days after last line of therapy (IMWG criteria 2016), with documented evidence.
• The patients should have measurable disease based on at least one of the following parameters：
• Serum M-protein ≥ 10 g/L;
• Urine M-protein ≥ 200 mg/24 hrs;
• For those whose Serum or Urine M- protein dose not meed the measurable criteria but the light chain type, serum free light chain (FLC): involved FLC level ≥ 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal
• Estimated life expectancy \> 12 weeks
• ECOG performance score 0-1；
• Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis
• Patients should maintain adequate organ function
• Women of childbearing age must undergo a serum pregnancy test with negative results before screening and lymphodepletion preconditioning with fludarabine and cyclophosphamide, and are willing to use effective and reliable method of contraception for at least 1 year after T cell infusion
• Men who actively have intercourse with child-bearing potential women must be willing to use effective and reliable method of contraception for at least 1 year after T cell infusion

You may not qualify if:

• Pregnant or lactating women；
• Positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema Pallidum antibody, hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg), HBV e antigen (HBeAg), HBV e antibody, hepatitis B core antibody, HBV DNA;
• Patients with any uncontrolled active infection including but not limited to active tuberculosis.
• Patients with AEs from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ 1, excluding hair loss, neuropathy and other events that the treating physician can determine to be tolerable.
• Patients who have ever had any CAR T cell therapy；
• Patients who have ever had anti-BCMA therapy；
• Patients have received allogeneic stem cell transplantation for treating multiple myeloma;
• Patients have received autologous stem cell transplantation less than 12 weeks before leukapheresis；
• Patients have received any anti-cancer treatment within 14 days before leukapheresis including but not limited to cytotoxic therapy, proteasome inhibitors, immunomodulatory agents, targeted therapies, epigenetic therapy or experimental drug therapy. If the field of radiation covers ≤ 5% of the bone marrow, the subjects are eligible to participate in the study regardless of the radiotherapy end date；
• Patients have received ≥ 5 mg prednisone daily or other equivalent dose of steroids within 14 days before leukapheresis or lymphodepletion；
• Patients have plasma cell leukemia, Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome or AL amyloidosis；
• Patients have been administered live attenuated vaccine 4 weeks before leukapheresis or lymphodepletion
• Patients allergic to component of study treatment.
• Patients have any of the condition as following within 6 months of ICF sign-off: New York Heart Association (NYHA) stage III or IV congestive heart failure, angina pectoris, myocardial infarction, coronary artery bypass graft, stroke (excluding lacunar stroke), history of clinically significant arrhythmia including but not limited to ventricular arrhythmia, significant QT interval prolongation, uncontrolled blood pressure as defined as systolic \> 160 mmHg, diastolic \> 100 mmHg, uncontrolled diabetes mellitus, pulmonary thrombolism, other conditions that investigators believe that participating in this clinical trial may endanger the health of the patients
• Patients are known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy

Sponsors & Collaborators

• CARsgen Therapeutics Co., Ltd.: lead
• Beijing Chao Yang Hospital: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Tianjin Medical University General Hospital: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• Beijing Hospital: collaborator
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Xiangya Hospital of Central South University: collaborator
• Peking University People's Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Sun Yat-sen University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (23)

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, China

Location

Beijing Chaoyang hospital

Beijing, Beijing Municipality, 100000, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Sun Yat-sen University Cancer Centre

Guangzhou, Guangdong, China

Location

The 2nd People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Location

The First Affiliated Hospital Of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

The first Affiliated Hospital, College of medicine, Zhejiang University

Hanzhou, Zhejiang, China

Location

The first Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

Beijing Boren Hospital

Beijing, China

Location

Beijing Hospital

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

Tongji Hospital of Tongji University

Shanghai, China

Location

Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Tianjin Medical University General Hospital

Tianjin, China

Location

Henan Provincial People's Hospital

Zhengzhou, China

Location

Related Publications (1)

• Fu C, Chen W, Cai Z, Yan L, Wang H, Shang J, Wu Y, Yan S, Gao W, Shi X, Han X, Tang F, Zheng G, Wen Y, Meng X, Yuan D, Wang H, Li Z. Long-term follow-up of zevor-cel in patients with relapsed/refractory multiple myeloma. Blood Adv. 2026 Jan 27;10(2):468-478. doi: 10.1182/bloodadvances.2025017365.

  PMID: 41160798 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

• Wenming CHEN, MD

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

• Zhengzheng FU, MD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Phase I is an open-label, dose escalation study and 2 cohorts to evaluate the safety and tolerability of treatment with CT053 and to determine maximum tolerable dose (MTD) and the Recommended Phase 2 Dose (RP2D) for CT053. Phase 2 is a single-arm, open, multi-center study, to evaluate the efficacy and safety of CAR-BCMA T cells (CT053) in subjects with RR/MM.

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 5, 2019
• Study Start: June 10, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (23)