A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR- F33S Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma.
Sponsor study identifier
interventional
35
1 country
4
Study Start
September 16, 2025
Actual (reported)Primary Completion
February 20, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 20, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A prospective, single-arm, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-F33S in patients with relapsed/refractory multiple myeloma(Investigator-initiated Study).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 20, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 30, 2025
Actual (reported)August 3, 2025
Actual (reported)September 16, 2025
Actual (reported)February 20, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 20, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Dose-limiting toxicity (DLT) rate.
DLT is classified according to the NCI-CTCAE V5.0 toxicity evaluation criteria and ASTCT consensus classification within 30 days after dose infusion (D1-D30), which is considered by the investigator or collaborator to be reasonably related to LCAR-F33S cell therapy.
From LCAR-F33S cell 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-F33S cell infusion
To determine the recommended dose for phase II clinical trials (RP2D)
RP2D was established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.
through the last subject of DLT exploration completion, about 2years.
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
Objective Response Rate (ORR)
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）
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)
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)
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
From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression, assessed about 2 years
Each subject will be given a single-dose LCAR- F33S cells infusion at each dose level.
Prior to infusion of the LCAR- F33S cell, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Beijing Boren Hospital
Beijing, China
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
Institute of Hematology & Blood Diseases Hospital
Lugui Qiu, MD
Institute of Hematology & Blood Diseases Hospital, China
First Submitted
July 30, 2025
First Posted
August 3, 2025
Study Start
September 16, 2025
Actual (reported)Primary Completion
Time to Cmax
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
Time to the last observed concentration
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.
Contact the study team to confirm eligibility.
Tianjin, China
Wuhan Union Hospital
Wuhan, China
February 20, 2028
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 20, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 29, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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