An Open Label,Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Autologous T Cell Injection Targeting GPRC5D OriCAR-017 in Patients With Relapsed and/or Refractory Multiplemyeloma

OriCell Therapeutics Co., Ltd.5 sites in 1 country83 target enrollmentOctober 26, 2023

ConditionsRelapsed and/or Refractory Multiple Myeloma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed and/or Refractory Multiple Myeloma
Sponsor: OriCell Therapeutics Co., Ltd.
Enrollment: 83
Locations: 5
Primary Endpoint: Maximum tolerated dose of OriCAR-017-P1
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM

Detailed Description

This is a Phase I and Phase II, open-label, multi-center study to assess the safety, pharmacokinetics, and efficacy of GPRC5D directed chimeric antigen receptor modified T cells injection (OriCAR-017) in n patients with relapsed and/or refractory multiplemyeloma (R/RMM).

Registry

clinicaltrials.gov

Start Date

October 26, 2023

End Date

August 31, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

OriCell Therapeutics Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of R/RMM according to the IMWG criteria;
•Expected survival period is \>12 weeks;
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2 at the time of ICF signature;
•The expression of GPRC5D in bone marrow plasma cells membrane is more than 20% by flow cytometry and/or immunohistochemistry, multiple myeloma with measurable lesions, and at least one of the following criteria must be met:
•Serum M protein \>5 g/L;
•Urine M protein level \>200 mg/24 hour;
•Serum free light chain (sFLC) \>100 mg/L and K/λ FLC ratio is abnormal;
•Primitive immature or monoclonal plasma cells \>5% by bone marrow cytology or flow cytometry.
•Subjects who had received at least 3 prior lines of therapy including (but not limited to) immunomodulatory drugs (IMiDs), proteasome inhibitors, anti-CD38 monoclonal antibodies, etc., but have failed treatment, including those who have experienced relapse (within 12 months), refractory or intolerant to the last line treatment regimen.

Exclusion Criteria

•Smoldering myeloma (asymptomatic)
•Multiple myeloma with only extramedullary lesions;
•Plasma cell leukemia;
•Concurrent amyloidosis;
•Central nervous system metastasis, leptomeningeal disease or metastatic central compression;
•HBsAg or HbcAb is positive, and the quantitative detection of hepatitis B virus (HBV) DNA in peripheral blood is more than 100 copies/L; hepatitis C virus (HCV) antibody and HCV RNA in peripheral blood is positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody is positive at Screening; Cytomegalovirus DNA test is positive;
•Had hypersensitivity or intolerance to any drug/excipient (including conditioning chemotherapy) used in this study;
•Previously received treatment targeting GPRC5D, including but not limited to antibodies, ADC, or CAR-T;
•Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study;
•Any uncontrolled active infection within 4 weeks prior to ICF signing or leukapheresis requires parenteral antibiotic, antiviral, or antifungal treatment

Outcomes

Primary Outcomes

Maximum tolerated dose of OriCAR-017-P1

Time Frame: Up to 28 days

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.

Dose-limiting toxicity (DLT)

Time Frame: Up to 28 days

tolerability

Secondary Outcomes

Objective Response Rate(From date of randomization until the date of first documented progression or date of death from any cause or withdraw, whichever came first, assessed up to 2 Years)
Antitumor efficacy-Duration of response (DOR)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
Pharmacokinetics (the number of cell copies and cell persistence duration in peripheral blood)(From date of randomization until the date of first documented progression or date of death from any cause or withdraw, whichever came first, assessed up to 2 years)
Long term survival follow up(From date of randomization until the date of first documented date of death from any cause, assessed up to 15 years)
Antitumor efficacy-Progression-free survival (PFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)