To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Second Provincial General Hospital

About this trial

To evaluate the safety and tolerability of anti-GPRC5D-CD19 CAR-T cells infusion in subjects with relapsed and refractory multiple myeloma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. The patient or their legal guardian understands and voluntarily signs the informed consent form and is expected to complete the follow-up examinations and treatments.

Alanine transaminase (ALT) ≤3 times the upper limit of normal (ULN);

Aspartate transaminase (AST) ≤3 times ULN;

Total bilirubin ≤1.5 times ULN;

Disqualifiers

1. Diagnosed with or treated for invasive malignant tumors other than multiple myeloma.

Trial design

Design model

Single group

Treatments tested in this trial

  • infusion of GPRC5D-CD19 CAR T injection

    Biological/Vaccine

    Infusion of GPRC5D-CD19 CAR T cells injection by dose of 1.0×10\^6 /kg±20 % CAR-T ,3.0×10\^6 /kg±20%、6.0×10\^6 /kg±20%. Administration method: intravenous infusion. Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: infusion of GPRC5D-CD19 CAR T injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate

Subjects were evaluated for efficacy according to the IMWG Efficacy Assessment Criteria (2016 revision).

Time frame
Day 0, Month 1.5, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 18, Month 24

Secondary outcomes

Other outcomes

Sponsors and contacts

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