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T Cells Expressing a Bispecific CAR Targeting CS1 and BCMA in Relapsed/Refractory Multiple Myeloma

NCT04662099 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-08-16

No results posted yet for this study

Summary

This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of the bispecific CAR T cells targeting CS1 and BCMA in patients with relapsed or refractory multiple myeloma.

Conditions

  • CS1+ or BCMA+ Multiple Myeloma

Interventions

BIOLOGICAL

Conditioning chemotherapy followed by CAR T cell infusion

Conditioning chemotherapy: Cyclophosphamide 250 mg/m\^2 and fludarabine 30 mg/m\^2 IV infusion on days -5, -4, and -3 CAR T cells infusion: 0.75x10\^6-3.0X10\^6 CAR+ T cells per kg of recipient bodyweight. if DLTs don't occur at the dose of 3.0X10\^6 CAR+ T cells per kg, the investigators will discuss whether to try higher dose.

Sponsors & Collaborators

  • Wuhan Si'an Medical Technology Co., Ltd

    collaborator UNKNOWN

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Heng Mei, M.D., Ph.D · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-25
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04662099 on ClinicalTrials.gov