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| Name | Class |
|---|---|
| Beijing Chao Yang Hospital | OTHER |
| The First Affiliated Hospital of Soochow University | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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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.
The study is composed of two stages, Phase I stage is for dose escalation and recommendation of phase 2 dose, and Phase II stage is to Detailed Description: verify the efficacy and safety of the dose proposed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-BCMA T Cells | Experimental | Phase I: The subjects are enrolled into 2 dose level cohorts in sequence. Phase II: Single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion | Minimal residual disease (MRD) negativity | 3 months post administration of CAR-T-cells |
| Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion |
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Inclusion Criteria:
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:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenming CHEN, MD | Beijing Chao Yang Hospital | Principal Investigator |
| Zhengzheng FU, MD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of bengbu medical college | Bengbu | Anhui | China | |||
| Beijing Chaoyang hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41160798 | Derived | 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. |
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| 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 |
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.
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TTR TIme to Response
| 3 months post administration of CAR-T-cells |
| Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion | Complete Response (CR) /stringent Complete Response (sCR) | 3 months post administration of CAR-T-cells |
| Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion | ≥Very Good Partial Response (VGPR), including VGPR, CR, sCR | 3 months post administration of CAR-T-cells |
| Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion | ORR at Wk12 | 3 months post administration of CAR-T-cells |
| Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion | CBR, clinical benefit rate | 3 months post administration of CAR-T-cells |
| Safety and tolerability of CAR-BCMA T cell therapy | AE&SAE | through 24 months post administration of CAR-T-cells |
| Pharmacokinetics (the cell persistence duration in peripheral blood) | Copy numbers of CAR-BCMA gene in peripheral blood | through 24 months post administration of CAR-T-cells |
| Pharmacokinetics (the cell persistence duration in peripheral blood) | Number of CAR positive cells in peripheral blood | through 24 months post administration of CAR-T-cells |
| Safety and tolerability of CAR-BCMA T cell therapy | positivity of ADA (Anti-CAR-T antibody) | through 24 months post administration of CAR-T-cells |
| Efficacy endpoint of CAR-BCMA T cells after infusion | Overal response rate (ORR) | through 24 months post administration of CAR-T-cells |
| Efficacy endpoint of CAR-BCMA T cells after infusion | Complete Response (CR) /stringent Complete Response (sCR) | through 24 months post administration of CAR-T-cells |
| Efficacy endpoint of CAR-BCMA T cells after infusion | ≥Very Good Partial Response (VGPR), including VGPR, CR, sCR | through 24 months post administration of CAR-T-cells |
| Efficacy endpoint of CAR-BCMA T cells after infusion | Duration of Response (DOR) | through 24 months post administration of CAR-T-cells |
| Efficacy endpoint of CAR-BCMA T cells after infusion | Clinical Benefit Rate (CBR) | through 24 months post administration of CAR-T-cells |
| Efficacy endpoint of CAR-BCMA T cells after infusion | Time to Response (TTR) | through 24 months post administration of CAR-T-cells |
| Efficacy endpoint of CAR-BCMA T cells after infusion | Minimal residual disease (MRD) negativity | through 24 months post administration of CAR-T-cells |
| Efficacy endpoint of CAR-BCMA T cells after infusion | Progression Free Survival (PFS) | through 24 months post administration of CAR-T-cells |
| Efficacy endpoint of CAR-BCMA T cells after infusion | Overall Survival (OS) | through 24 months post administration of CAR-T-cells |
| Beijing |
| Beijing Municipality |
| 100000 |
| 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 | 215006 | 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 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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