Health TrialsbyHealthPanel

Safety and Efficacy of GPRC5D CAR-T Cell Therapy in Relapsed/Refractory Plasma Cell Disorders

ConditionPlasma Cell Dyscrasias
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age14-75
SponsorQi deng

About this trial

This study is an open-label, single-arm, dose-escalation and expansion, prospective clinical trial. It enrolls patients with relapsed/refractory plasma cell disorders, administers GPRC5D CAR-T cell therapy, follows up to observe adverse reactions after medication, collects relevant data on treatment efficacy, evaluates the safety and efficacy of CAR-T cells, and simultaneously investigates the cellular kinetic characteristics of CAR-T cells.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

According to the World Health Organization (WHO) Classification of Haematopoietic and Lymphoid Tissue Tumours (2022), patients with relapsed/refractory plasma cell disorders that have received adequate treatment and lack effective therapeutic options, including: multiple myeloma, plasma cell leukemia, extramedullary plasmacytoma, solitary plasmacytoma, or primary amyloidosis.i) Relapsed: Disease progression occurs after one or more prior treatments, requiring salvage therapy, and does not meet the criteria for refractory disease.ii) Refractory: No response to initial treatment regimen or salvage therapy, or disease progression within 60 days after treatment. No response is defined as failure to achieve minimal response (MR) or disease progression during treatment.

The subject's predicted survival time is not less than three months.

Tumor cells confirmed to be GPRC5D positive by Flow Cytometry (FCM) or Immunohistochemistry.

The subject failed autologous and allogeneic hematopoietic stem cell transplantation.

Disqualifiers

Severe heart failure with left ventricular ejection fraction (LVEF) < 50%.

History of severe pulmonary function impairment.

Concurrent other progressive malignant tumors.

Concurrent severe infection that cannot be effectively controlled.

Trial design

Design model

Single group

Treatments tested in this trial

  • GPRC5D CAR-T cell intravenous infusion

    Biological/Vaccine

    GPRC5D CAR-T cell intravenous infusion

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: GPRC5D CAR-T cell intravenous infusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Monitor and record adverse events

Time frame
up to two years after the CAR-T cell infusion
2

Overall Response Rate

Time frame
up to two year after the CAR-T cell infusion

Secondary outcomes

1

Cell pharmacokinetics Dynamic indicators

CAR-T/T% by flow cytometry

Time frame
up to one month after the CAR-T infusion

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Qi deng

Lead sponsor

Tianjin First Central Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: