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| Name | Class |
|---|---|
| Nanjing Legend Biotech Co. | INDUSTRY |
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A prospective, two-cohort, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61S and LCAR-M61D in patients with relapsed/refractory multiple myeloma.
This study was a prospective, two-cohort, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61S and LCAR-M61D in patients with relapsed/refractory multiple myeloma. All subjects who meet the eligibility criteria will receive intravenous injection of LCAR-M61S or LCAR-M61D cell injection. The study will include the following sequential phases: screening, apheresis, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCAR-M61S and LCAR-M61D | Experimental | Each subject will be given a single-dose LCAR-M61S or LCAR-M61D cells infusion at each dose level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCAR-M61S cells preparation | Biological | Biological: LCAR-M61S or LCAR-M61D cells intravenous infusion; Prior to infusion of the LCAR-M61S and LCAR-M61D cell preparation, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) rate | DLT was classified according to the NCI-CTCAE V5.0 toxicity evaluation criteria and ASTCT consensus classification within 30 days after dose infusion (D1-D30), which was considered by the investigator or collaborator to be reasonably related to LCAR-M61S or LCAR-M61D cell therapy. | From LCAR-M61S and LCAR-M61D cell preparations infusion (Day 1) until the 30th day of follow-up period, assessed up to 30 days |
| Incidence, severity, and type of treatment-emergent adverse events (TEAEs) | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | From the date of signing ICF to the date (2 years after LCAR-M61S and LCAR-M61D cell preparation infusion (Day 1) |
| To determine the recommended dose for phase II clinical trials (RP2D) | RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design | Through the last subject of DLT exploration completion, about 2 years |
| Maximum concentration (Cmax) | The maximum observed concentration of CAR positive T cells or transgene CAR copy number in peripheral blood. | From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years |
| Time to Cmax (Tmax) | The time it takes to reach the maximum concentration of CAR positive T cells or transgene CAR copy number in peripheral blood. | From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | According to International Myeloma Working Group (IMWG) efficacy criteria.ORR was defined as the proportion of patients with PR or better response after infusion of LCAR-M61S or LCAR-M61D cells. | From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lijuan Chen | Contact | 15850521836 | chenljb@126.com | |
| Xuxing Shen | Contact | 15720803161 | ruxiaoguo1992@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lijuan Chen | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Cancer Hospital | Hefei | Anhui | 230031 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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Single Group Assignment & Two-cohort; LCAR-M61S and LCAR-M61D cells preparation intravenous infusion; Pretreatment of cyclophosphamide and fludarabine.
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| LCAR-M61D cells preparation | Biological | Biological: LCAR-M61S or LCAR-M61D cells intravenous infusion; Prior to infusion of the LCAR-M61S and LCAR-M61D cell preparation, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine. |
|
|
| Time to the last observed concentration (Tlast) | The time it takes to reach the last observed concentration of CAR positive T cells or transgene CAR copy number in peripheral blood. | From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years |
| Area Under the Curve (AUC) of the concentration | The exposure of CAR positive T cells or transgene CAR copy number in peripheral blood experienced by the subject in a certain time interval. | From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years |
| Very Good Partial Response Rate（VGPR） | Proportion of subjects achieving VGPR according to IMWG criteria. | From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years |
| Complete response（CR） | Proportion of subjects achieving CR according to IMWG criteria. | From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years |
| Stringent complete response（sCR） | Proportion of subjects achieving sCR according to IMWG criteria. | From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years |
| Minimal residual disease (MRD) negative rate | Proportion of subjects achieving minimal residual disease (MRD) negative rate according to IMWG criteria. | From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression，assessed about 2 years |
| Time-to-response（TTR） | According to International Myeloma Working Group (IMWG) efficacy criteria.TTR was defined as the interval from the date of the first infusion of the LCAR-M61S or LCAR-M61D cells preparation to the date of the first efficacy assessment for which the subject met all criteria for PR or better. Analyses were performed only in responders. | From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years |
| Duration of response（DOR） | According to International Myeloma Working Group (IMWG) efficacy criteria. DOR was defined as the time from the first documented response (PR or better response) to the first documented evidence of disease progression (as defined according to IMWG criteria) or death from any cause . | From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years |
| Progression-free survival（PFS） | According to International Myeloma Working Group (IMWG) efficacy criteria.PFS was defined as the interval from the date of the first infusion of the LCAR-M61S or LCAR-M61D cells preparation to the first documentation of disease progression (according to IMWG criteria) or death from any cause, whichever occurred first. | From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years |
| Overall survival（OS） | According to International Myeloma Working Group (IMWG) efficacy criteria.Overall survival (OS) was defined as the interval from the date of the first infusion of LCAR-M61S or LCAR-M61D cells preparation to death. | From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years |
| Occurrence rate of antidrug antibody | Occurrence rate of LCAR-M61S or LCAR-M61D cells preparation ADA | From LCAR-M61S or LCAR-M61D cells preparation infusion until the date of first documented progression or study completion，assessed about 2 years |
| Henan Cancer Hospital | Zhengzhou | Henan | 450003 | China |
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| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
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| Beijing Gobroad Hospital | Beijing | 102206 | China |
|
| 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 |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |