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A Study of DeepTag-GPRC5D Targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

ConditionRelapse/Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHe Huang

About this trial

Clinical Trial for the safety and efficacy of DeepTag-GPRC5D targeted CAR-T cells therapy for refractory/relapsed multiple myeloma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Those who voluntarily participated in this trial and provided informed consent;

2. Gender unlimited，18<Age≤75;

3. Estimated life expectancy of minimum of 12 weeks;

4. ECOG 0-2;

Disqualifiers

1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;

2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;

3. Pregnant (or lactating) women;

4. Patients with HIV infection;

Trial design

Design model

Single group

Treatments tested in this trial

  • DeepTag-GPRC5D Targeted CAR T-cells

    Biological/Vaccine

    Each subject receive DeepTag-GPRC5DTargeted CAR T-cells by intravenous infusion

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Administration of DeepTag-GPRC5D Targeted CAR T-cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Adverse events assessed according to NCI-CTCAE v5.0 criteria

Time frame
Up to 28 years after Treatment
2

Incidence of treatment-emergent adverse events (TEAEs)

Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Time frame
Up to 2 years after Treatment

Secondary outcomes

1

Multiple Myeloma (MM), Overall response rate (ORR)

Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR)

Time frame
Up to 2 years after Treatment
2

Progression-free survival (PFS)

The time from randomization or start of study treatment until objective tumor progression or death

Time frame
Up to 2 years after Treatment
3

Duration of remission,DOR

The time from CR/CRi and PR to disease relapsed or death due to disease

Time frame
Up to 1 years after Treatment

Other outcomes

Sponsors and contacts

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

He Huang

Lead sponsor

Zhejiang University

Sponsor institution

Yake Biotechnology Ltd.

Collaborator

Source ClinicalTrials.gov
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