Relapsed/Refractory Multiple MyelomaNCT06472479

LCAR-M61S and LCAR-M61D in Treatment of Relapsed/Refractory Multiple Myeloma

A study testing LCAR-M61S cells preparation and LCAR-M61D cells preparation in people with Relapsed/Refractory Multiple Myeloma, run by The First Affiliated Hospital with Nanjing Medical University at 4 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsed/Refractory Multiple Myeloma
What is being tested?: LCAR-M61S cells preparation and LCAR-M61D cells preparation
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 4 sitesChina
Study dates: 1 Jul 2024to 12 Oct 2029
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects voluntarily participate in clinical research;
Age ≥18 years old;
Eastern Cooperative Oncology Group (ECOG) score 0-2;
Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria;
Measurable lesions were present;
Subjects have received at least three previous lines of multiple myeloma therapy, each with at least one complete therapy cycle, unless the best response to the therapeutic regimen was documented as disease progression (PD confirmed according to IMWG criteria);
Expected survival ≥3 months;
Clinical laboratory values in the screening period meet criteria;

Who cannot join

Received previous therapy targeting GPRC5D and/or CD19 targets;
Prior antineoplastic therapy and meet exclusion criteria (before apheresis);
Subjects had Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.
Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;
Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known.
Serious underlying diseases were present;
Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment.
Also enrolled in other clinical studies.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lijuan Chen contact

15850521836

chenljb@126.com

Xuxing Shen contact

15720803161

ruxiaoguo1992@163.com

China4 sites

Beijing Gobroad Hospital
Beijing, 102206
Kai Hu, 15010390336, huk@gobroadhealthcare.com
Anhui Cancer Hospital
Hefei, Anhui, 230031
Kaiyang Ding, 13966672170, dingky@126.com
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Lijuan Chen, 15850521836, chenljb@126.com
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Xudong Wei, 13837169301, weixudong63@126.com

Other trials in China

About this study

Official title: A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR-M61S and LCAR-M61D Cell Preparations in Patients With Relapsed/Refractory Multiple Myeloma

Read the detailed description

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.

Conditions: Relapsed/Refractory Multiple Myeloma
Being tested: LCAR-M61S cells preparation, LCAR-M61D cells preparation
Keywords: Multiple myeloma, Relapsed/Refractory multiple myeloma
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LCAR-M61S cells preparationBiological
Also called Cyclophosphamide, Fludarabine
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.
LCAR-M61D cells preparationBiological
Also called Cyclophosphamide, Fludarabine
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.

Study groups in NCT06472479
Study group	Role	What they receive
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. Receives: Biological: LCAR-M61S cells preparation; Biological: LCAR-M61D cells preparation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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 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.
Measured: 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.
Measured: 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

Secondary outcomes (10)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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
Measured: From LCAR-M61S or LCAR-M61D cells preparation infusion until the date of first documented progression or study completion，assessed about 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202412 Oct 2029

First posted25 Jun 2024
Study start1 Jul 2024 (estimated)
Primary completion22 Aug 2028 (estimated)
Study completion12 Oct 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single Group Assignment \& Two-cohort; LCAR-M61S and LCAR-M61D cells preparation intravenous infusion; Pretreatment of cyclophosphamide and fludarabine.
Masking: None (open label)
Enrolment: 66 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06472479
Sponsor's protocol ID: LB2401-0001
Status last verified: Jun 2024
First submitted: 6 Jun 2024
Last updated: 28 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR-M61S and LCAR-M61D Cell Preparations in Patients With Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT06472479
Acronym / sponsor ID: LB2401-0001
Conditions: Relapsed/Refractory Multiple Myeloma
Keywords: Multiple myeloma, Relapsed/Refractory multiple myeloma
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 66 participants (estimated)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
Collaborators: Nanjing Legend Biotech Co.
Study start: 1 Jul 2024 (estimated)
Primary completion: 22 Aug 2028 (estimated)
Study completion: 12 Oct 2029 (estimated)
First posted: 25 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single Group Assignment \& Two-cohort; LCAR-M61S and LCAR-M61D cells preparation intravenous infusion; Pretreatment of cyclophosphamide and fludarabine.

Arm	Type	Receives
LCAR-M61S and LCAR-M61D	Experimental	Biological: LCAR-M61S cells preparation, Biological: LCAR-M61D cells preparationEach subject will be given a single-dose LCAR-M61S or LCAR-M61D cells infusion at each dose level.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subjects voluntarily participate in clinical research;
Age ≥18 years old;
Eastern Cooperative Oncology Group (ECOG) score 0-2;
Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria;
Measurable lesions were present;

Key exclusion criteria (8 listed)

Received previous therapy targeting GPRC5D and/or CD19 targets;
Prior antineoplastic therapy and meet exclusion criteria (before apheresis);
Subjects had Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.
Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;
Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LCAR-M61S cells preparationAlso: Cyclophosphamide, FludarabineBiological: 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.	Biological	LCAR-M61S and LCAR-M61D
LCAR-M61D cells preparationAlso: Cyclophosphamide, FludarabineBiological: 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.	Biological	LCAR-M61S and LCAR-M61D

Primary outcome

Dose-limiting toxicity (DLT) rate
Time frame: From LCAR-M61S and LCAR-M61D cell preparations infusion (Day 1) until the 30th day of follow-up period, assessed up to 30 days
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.
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Time frame: From the date of signing ICF to the date (2 years after LCAR-M61S and LCAR-M61D cell preparation infusion (Day 1)
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.
To determine the recommended dose for phase II clinical trials (RP2D)
Time frame: Through the last subject of DLT exploration completion, about 2 years
RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design
Maximum concentration (Cmax)
Time frame: 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
The maximum observed concentration of CAR positive T cells or transgene CAR copy number in peripheral blood.
Time to Cmax (Tmax)
Time frame: 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
The time it takes to reach the maximum concentration of CAR positive T cells or transgene CAR copy number in peripheral blood.
Time to the last observed concentration (Tlast)
Time frame: 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
The time it takes to reach the last observed concentration of CAR positive T cells or transgene CAR copy number in peripheral blood.
Area Under the Curve (AUC) of the concentration
Time frame: 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
The exposure of CAR positive T cells or transgene CAR copy number in peripheral blood experienced by the subject in a certain time interval.

10 secondary outcomes

Objective Response Rate (ORR)
Time frame: 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）
Time frame: 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）
Time frame: 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）
Time frame: 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
Time frame: 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）
Time frame: 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）
Time frame: 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）
Time frame: 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）
Time frame: 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
Time frame: From LCAR-M61S or LCAR-M61D cells preparation infusion until the date of first documented progression or study completion，assessed about 2 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
Individual participant dataSharing planned: No

Related trials for Relapsed/Refractory Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 3
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1/2
A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Multiple Myeloma
RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Relapsed or Refractory Multiple Myeloma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Lijuan Chen contact

15850521836

chenljb@126.com

Xuxing Shen contact

15720803161

ruxiaoguo1992@163.com

Lijuan Chen principal investigator

The First Affiliated Hospital with Nanjing Medical University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lijuan Chen (15850521836, chenljb@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) rate (time frame: From LCAR-M61S and LCAR-M61D cell preparations infusion (Day 1) until the 30th day of follow-up period, assessed up to 30 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06472479.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.