Evaluating a new CAR-T cell therapy for relapsed/refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OriCAR-017, an anti-GPRC5D CAR-T cell therapy, in patients with relapsed or refractory multiple myeloma. The study is structured in phases, starting with a dose escalation involving a small group of subjects, followed by a dose expansion and a larger Phase II stage. Participants will receive the therapy through a single intravenous infusion, and the study will monitor their responses and any adverse effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Capable of giving signed informed consent

Subjects aged 18 to 75 years (inclusive) at Screening (signing the ICF).

Expected survival period is \>12 weeks.

Diagnosis of MM according to the IMWG criteria (2016 version).

One of the following criteria must be met:

If immunoglobulin (Ig)G type MM, then serum M protein \>10 g/L; if IgA, IgD, IgE or IgM type MM, then serum M protein \>5 g/L

Urine M protein level \>200 mg/24 hour

If light chain type MM, then serum free light chain (sFLC) \>100 mg/L and K/λ FLC ratio is abnormal.

Extramedullary lesions (\>1 cm for diameter of the short axis).

For Phase I (dose-escalation) - Subjects who had received at least 3 prior lines of therapy, had previous exposure to BCMA-Ag+ therapies, and were refractory to the last line of therapy.

For Phase I (dose-expansion) and Phase II: Subjects with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BLENREP), and BCMA-CAR-T (such as CARVYKT1TM)

Subjects with adequate hematologic, renal, hepatic, pulmonary and cardiac function.

Subject and partners willing to take and or use effective contraceptive measures until 2 years post IMP infusion.

Exclusion Criteria:

Pregnant or breastfeeding.

Seropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection

Known active or prior history of CNS involvement

History of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) caused damage to terminal organs or required systemic application of immunosuppressive or other drugs in the past 2 years

Presence of uncontrolled active infection

Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study.

Subjects who received allogeneic stem cell therapy.

Any condition that in the opinion of the Investigator, would interfere with evaluation of the IMP.

Received Bendamustine treatment 1 year prior to Screening Visit.

Where it's running

• Northside Hospital
  Atlanta, Georgia, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• BCMA-TGFβ CAR-T Cells in Relapsed or Refractory Myeloma

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• CD7 CAR-T therapy followed by allogeneic stem cell transplant for relapsed/refractory CD7-positive blood cancers

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• CAR-T therapy outcomes and quality of life in older adults with B‑cell lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.