Clinical Trial to Evaluate CT053 in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 1)
NCT ID: NCT03975907
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
121 participants
INTERVENTIONAL
2019-06-10
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
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.
TREATMENT
NONE
Study Groups
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CAR-BCMA T Cells
Phase I: The subjects are enrolled into 2 dose level cohorts in sequence. Phase II: Single arm
CAR-BCMA T Cells
The CAR-BCMA T cells (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting BCMA.
Interventions
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CAR-BCMA T Cells
The CAR-BCMA T cells (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting BCMA.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years and ≤ 75 years, male or female
3. 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)
4. 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)；
5. 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.
6. 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
7. Estimated life expectancy \> 12 weeks
8. ECOG performance score 0-1；
9. Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis
10. Patients should maintain adequate organ function
11. 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
12. 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
Exclusion Criteria
2. 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;
3. Patients with any uncontrolled active infection including but not limited to active tuberculosis.
4. 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.
5. Patients who have ever had any CAR T cell therapy；
6. Patients who have ever had anti-BCMA therapy；
7. Patients have received allogeneic stem cell transplantation for treating multiple myeloma;
8. Patients have received autologous stem cell transplantation less than 12 weeks before leukapheresis；
9. 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；
10. Patients have received ≥ 5 mg prednisone daily or other equivalent dose of steroids within 14 days before leukapheresis or lymphodepletion；
11. Patients have plasma cell leukemia, Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome or AL amyloidosis；
12. Patients have been administered live attenuated vaccine 4 weeks before leukapheresis or lymphodepletion
13. Patients allergic to component of study treatment.
14. 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
15. Patients are known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy
16. patients are oxygen dependent as defined by the blood oxygen saturation (finger oxygen detection method) can be maintained \> 95% only by oxygen inhalation before leukapheresis
17. Patients with second malignancies in addition to MM are not eligible if the second malignancy has required treatment within the past 5 years or is not in complete remission. There are two exceptions to this criterion: successfully treated cervical carcinoma in situ and non-metastatic basal cell skin carcinoma
18. Patients have central nervous system (CNS) metastases or CNS involvement (including cranial neuropathies or mass lesions and leptomeningeal disease). Patients with history of spinal cord compression from MM are eligible provided spinal cord compression has been treated with surgery or radiation at least 28 days prior to study entry
19. Patients are unable or unwilling to comply with the requirements of clinical trial
20. Patients have received major surgery 2 weeks prior to leukapheresis or 4 weeks prior to lymphodepletion and after the study treatment (excluding cataract and other local anesthesia)
21. Patients are relatives to investigator or his/her staff, or those who may have an interest in the investigator and/or his/her staff.
18 Years
75 Years
ALL
No
Sponsors
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Beijing Chao Yang Hospital
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Tianjin Medical University General Hospital
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
Beijing Hospital
OTHER_GOV
Shanghai Tongji Hospital, Tongji University School of Medicine
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Xiangya Hospital of Central South University
OTHER
Peking University People's Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Sun Yat-sen University
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
CARsgen Therapeutics Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Wenming CHEN, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Chao Yang Hospital
Zhengzheng FU, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Soochow University
Locations
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The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
Beijing Chaoyang hospital
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Centre
Guangzhou, Guangdong, China
The 2nd People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
The first Affiliated Hospital, College of medicine, Zhejiang University
Hanzhou, Zhejiang, China
The first Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Beijing Boren Hospital
Beijing, , China
Beijing Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
Tongji Hospital of Tongji University
Shanghai, , China
Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
Shanghai, , China
Tianjin Medical University General Hospital
Tianjin, , China
Henan Provincial People's Hospital
Zhengzhou, , China
Countries
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References
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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. 2025 Oct 29:bloodadvances.2025017365. doi: 10.1182/bloodadvances.2025017365. Online ahead of print.
Other Identifiers
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CT053-MM-01
Identifier Type: -
Identifier Source: org_study_id
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