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A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study

ConditionsNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOriCell Therapeutics Co., Ltd.

About this trial

The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma.

RIGEL Study

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • OriCAR-017

    Drug

    Anti-GPRC5D CAR-T cell product

Treatment groups

81 Participants
are divided into 1 treatment group
Group A: OriCAR-017Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum tolerated dose (MTD) of OriCAR-017 US-P1

The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level.

Time frame
Up to 28 days
2

Dose-limiting toxicity (DLT)

A DLT is defined as any of the treatment-emergent adverse events (TEAEs; a TEAE is defined as an adverse event \[AE\] that starts on or after the first administration of study medication) condition or concomitant medications.

Time frame
Up to 28 days

Secondary outcomes

1

Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM

Assess concentration of CAR-T cells in peripheral blood

Time frame
Up to 2 years
2

Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM

Assess PD markers related to CAR-T therapy in peripheral blood.

Time frame
Up to 2 years
3

Assessment of Duration of Response (DOR) of treatment in patients with RR/MM

DOR as assessed by Local Investigators according to the IMWG Criteria

Time frame
Up to 2 years
4

Progress-Free Survival (PFS) of treatment in patients with RR/MM

PFS as assessed by Local Investigators according to the IMWG Criteria

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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

OriCell Therapeutics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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