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LCAR-F33S in Treatment of Relapsed/Refractory Multiple Myeloma

ConditionRelapsed/Refractory Multiple Myeloma(MM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Legend Biotech Co.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Received previous therapy targeting FcRH5 targets.

Prior antineoplastic therapy and meet exclusion criteria (before apheresis);

Subjects had Plasma cell leukemia, 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;

Trial design

Design model

Single group

Treatments tested in this trial

  • LCAR- F33S cells intravenous infusion

    Biological/Vaccine

    Prior to infusion of the LCAR- F33S cell, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: LCAR-F33SExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From LCAR-F33S cell infusion (Day 1) until the 30th day of follow-up period, assessed up to 30 days
2

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.

Time frame
From the date of signing ICF to the date 2 years after LCAR-F33S cell infusion
3

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.

Time frame
through the last subject of DLT exploration completion, about 2years.
4

Maximum concentration (Cmax)

The maximum observed concentration of CAR positive T cells or transgene CAR copy number in peripheral blood.

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

Secondary outcomes

1

Objective Response Rate (ORR)

According to International Myeloma Working Group (IMWG) efficacy criteria. ORR is defined as the proportion of patients with PR or better response after infusion of LCAR-F33S cells.

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
2

Very Good Partial Response Rate（VGPR）

Proportion of subjects achieving VGPR according to IMWG criteria.

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
3

Complete response(CR)

Proportion of subjects achieving CR according to IMWG criteria.

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
4

Stringent complete response(sCR)

Proportion of subjects achieving sCR according to IMWG criteria.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Legend Biotech Co.

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Collaborator

Source ClinicalTrials.gov
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