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New treatment option for Relapsed/Refractory Multiple Myeloma
Official title A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
ClinicalTrials.gov ID: NCT05219721
What this study is testing
What is CAR-T (CAR-GPRC5D)?
CAR-T (CAR-GPRC5D) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed/refractory multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a single-center, open-label, dose-exploration study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R/R MM or plasma cell leukemia.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people must satisfy all the following criteria to be enrolled in the study:
- age 18 to 75 years old, male or female.
- people have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs)...
- Evidence of cell membrane GPRC5D expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue (e.g., bone...
- The people should have measurable disease based on at least one of the following parameters: The proportion of primitive immature or monoclonal...
You likely can't join if
- The presence of any of the following will exclude a subject from enrollment:
- people who are known to have GVHD or need long-term immunosuppressive therapy.
- people have received any anti-cancer treatment as follows: monoclonal antibody for treating multiple myeloma within 21 days before leukapheresis, or...
- people who were receiving a used therapeutic dose of corticosteroid treatment (defined as prednisone or equivalent \> 20mg) within 7 days prior to...
- people with hypertension that cannot be controlled by medication.
- people with serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening)...
See the full eligibility criteria
- people must satisfy all the following criteria to be enrolled in the study:
- age 18 to 75 years old, male or female.
- people have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs). According to the International Myeloma Working Group (IMWG) consensus...
- Evidence of cell membrane GPRC5D expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue (e.g., bone marrow biopsies, or plasmacytoma).
- The people should have measurable disease based on at least one of the following parameters: The proportion of primitive immature or monoclonal plasma cells detected by bone marrow cytology, bone marrow biopsy, or flow...
- ECOG performance score 0-2.
- Estimated life expectancy ≥ 12 weeks.
- people should have adequate organ function:
- Hematology: Absolute neutrophil count (ANC) ≥1×10\^9 /L (prior use of growth factor support is permitted, but people must not have received supportive treatment within 7 days prior to laboratory examination); absolute...
- Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); total serum bilirubin ≤ 1.5×ULN.
- Renal function: Creatinine clearance rate (CrCl) calculated according to Cockcroft-Gault formula ≥ 40 ml/min.
- Coagulation function: Fibrinogen ≥ 1.0 g/L; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, prothrombin time (PT) ≤1.5×ULN.
- SpO2 \> 91%.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- The subject and his/her spouse agree to use an effective contraceptive tool or medication (excluding safety period contraception) for one year from the date of the subject's informed consent to the date of CAR T cell...
- Subject must sign the informed consent form approved by ethics board in person before starting any screening procedure.
- The presence of any of the following will exclude a subject from enrollment:
- people who are known to have GVHD or need long-term immunosuppressive therapy.
- people have received any anti-cancer treatment as follows: monoclonal antibody for treating multiple myeloma within 21 days before leukapheresis, or cytotoxic therapy or proteasome inhibitors within 14 days before...
- people who were receiving a used therapeutic dose of corticosteroid treatment (defined as prednisone or equivalent \> 20mg) within 7 days prior to screening, except for physiological alternatives, inhalation, or topical...
- people with hypertension that cannot be controlled by medication.
- people with serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmias.
- people with systemic diseases that the investigator determined to be unstable include, but are not limited to, severe liver and kidney or metabolic diseases requiring medical treatment.
- people with second malignancies in addition to MM within the past 5 years before the screening, exceptions to this criterion: successfully treated cervical carcinoma in situ and non-metastatic basal or squamous cell...
- people with a history of organ transplantation.
- people have received major surgery within 2 weeks prior to leukapheresis or plan to receive surgery during the study or within 2 weeks after the study treatment (excluding local anesthesia).
- people participated in another treatment clinical study 1 months before signing the informed consent (ICF);
- people with any uncontrolled active infection needed to receive systemic therapy within 7 days before leukapheresis collection (excluding # CTCAE grade 2 urogenital infection and upper respiratory infection).
- Positive for any of the following tests:
- Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positive and detectable HBV DNA in peripheral blood
- Hepatitis C virus (HCV) antibody and hepatitis C virus RNA in peripheral blood
- Human immunodeficiency virus (HIV) antibody
- Cytomegalovirus (CMV) DNA
- Treponema Pallidum antibody
- Pregnant or lactating women.
- people with mental illness or consciousness disorder or disease of the central nervous system
- Other conditions that researchers consider inappropriate for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.