Health TrialsbyHealthPanel

Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma

ConditionsMultiple MyelomaPlasmacytoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShenzhen Geno-Immune Medical Institute

About this trial

The aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female subjects with multiple myeloma or plasmacytoma

Strictly complete remission (sCR) is a treatment goal

Expected survival > 12 weeks

After prior auto-SCT is eligible regardless of other prior therapies

Disqualifiers

Pregnant or lactating women

Uncontrolled active infection

Active HIV, hepatitis B or hepatitis C infection

Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.

Trial design

Design model

Single group

Treatments tested in this trial

  • CAR-T cells

    Biological/Vaccine

    Infusion of multi-CAR-T cells

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: CAR-T cells to treat MMExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of patients with treatment related adverse effects

The percentage of participants with treatment-related adverse events, as assessed by CTCAE v4.0

Time frame
1 month

Secondary outcomes

1

Anti-tumor activity of the fourth generation multiple CAR-T cells after infusion

Anti-tumor activity of the fourth generation multiple CAR-T cells after infusion by measuring the CAR copies in the blood

Time frame
1 year
2

Anti-tumor activity of fourth generation multiple CAR-T cells in patients with high-risk MM or plasmacytoma

Anti-tumor activity of fourth generation multiple CAR-T cells in patients with high-risk MM or plasmacytoma by examination of known tumor indicators

Time frame
1 year

Other outcomes

Sponsors and contacts

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

Shenzhen Geno-Immune Medical Institute

Lead sponsor

Source ClinicalTrials.gov
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