Health TrialsbyHealthPanel

A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed/ Refractory Multiple Myeloma

ConditionsRelapsedRefractoryMultiple Myeloma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Cell Therapy Group Co.,Ltd

About this trial

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologouschimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed/refractory multiple myeloma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Understand and voluntarily sign an informed consent form (ICF) before conducting any research related evaluations/procedures;

Age range: 18-75 years old;

Expected survival period is not less than 12 weeks;

ECOG score ≤ 2 points;

Disqualifiers

Asymptomatic (smoking type) multiple myeloma;

Multiple myeloma with only extramedullary lesions present;

Plasma cell leukemia;

Merge amyloidosis;

Trial design

Design model

Single group

Treatments tested in this trial

  • CD19/CD20/BCMA CAR-T

    Drug

    CD19/CD20/BCMA CAR T therapy

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: CD19/CD20/BCMA CAR-T cells therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity(DLT)

Safety

Time frame
[Time Frame: Day0-Day28]
2

Maximum tolerated dose (MTD)

Evaluate the incidence, severity, and correlation of SAE Tolerability

Time frame
[Time Frame: Day0-Day28]

Secondary outcomes

1

Maximum Plasma Concentration(Cmax)

Pharmacokinetics(PK)

Time frame
[Time Frame: Day0-Day28#Day0-undetectable for CAR positive T cells]
2

Maximum Plasma Concentration Time (Tmax)

Pharmacokinetics(PK)

Time frame
[Time Frame: Day0-Day28#Day0-undetectable for CAR positive T cells]
3

Area Under Curve (AUC)

Pharmacokinetics(PK)

Time frame
[Time Frame: Day0-Day28#Day0-undetectable for CAR positive T cells]
4

CAR positive T cells

Pharmacokinetics(PK)

Time frame
[Time Frame: Day0-Day28#Day0-undetectable for CAR positive T cells]

Other outcomes

Sponsors and contacts

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

Shanghai Cell Therapy Group Co.,Ltd

Lead sponsor

Source ClinicalTrials.gov
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