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Safety and Efficacy of Anti-BCMA/FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXuzhou Medical University

About this trial

This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-BCMA/FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-BCMAFcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA/FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • anti-BCMA/FcRL5 CAR T

    Drug

    anti-BCMA/FcRL5 autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10\^6/kg CAR+ T cells after receiving lymphodepleting chemotherapy. Other Name:

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: anti BCMA/FcRL5 CAR-TExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events

Adverse events assessed according to NCI-CTCAE v5.0

Time frame
Baseline up to 28 days after CAR-T cells infusion

Secondary outcomes

1

overall response rate (ORR)

Assessment of ORR at Month 6, 12, 18 and 24

Time frame
Month 6, 12, 18 and 24
2

complete response (CR)

Assessment of CR at Month 6, 12, 18 and 24

Time frame
Month 6, 12, 18 and 24
3

Overall survival (OS)

Assessment of OS at Month 6, 12, 18 and 24

Time frame
Month 6, 12, 18 and 24
4

Event-free survival (EFS)

Assessment of EFS at Month 6, 12, 18 and 24

Time frame
Month 6, 12, 18 and 24

Other outcomes

Sponsors and contacts

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

Xuzhou Medical University

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University

Sponsor institution

Source ClinicalTrials.gov
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