A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia (NCT05759793) | Clinical Trial Compass
RecruitingPhase 1
A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
China12 participantsStarted 2023-03-30
Plain-language summary
This study is a single-center, open-label, dose-escalation study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R/R MM or Plasma Cell Leukemia.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. age 18 to 75 years old, male or female.
. Subjects 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 marrow biopsies, or plasmacytoma).
. The subjects 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 cytometry is ≥ 10%.
. Serum M-protein ≥ 10 g/L for IgG type, serum M-protein ≥ 5 g/L for other types, such as IgA, IgD, IgM, IgE.
. Urine M-protein ≥ 200 mg/24 hrs.
. For those whose Serum or Urine M-protein does not meet the measurable criteria but the light chain type, serum free light chain (sFLC) : involved sFLC level ≥ 10mg/dL (100 mg/L) provided serum FLC ratio is abnormal.
Exclusion criteria
. Subjects who are known to have GVHD or need long-term immunosuppressive therapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily designed to find a safe dose of CAR-GPRC5D rather than to prove it works, what does that mean for my personal risk compared to my potential benefit at this stage?
2The trial is measuring dose-limiting toxicities across different dose groups — if I were to enroll, which dose group would I likely be placed in, and what kinds of side effects have been seen so far at those doses?
3CAR-T therapies can sometimes cause serious reactions like cytokine release syndrome or neurological effects — given my specific health history, how would you manage those risks if they occurred during this trial?
4I have relapsed or refractory multiple myeloma — are there any standard treatment options I haven't yet tried, like other approved CAR-T therapies or bispecific antibodies, that might be worth considering before a Phase 1 study like this one?
5This trial also includes patients with plasma cell leukemia, which is a different and rarer condition — does my specific diagnosis affect whether this trial might be a reasonable fit to discuss with my care team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of dose-limiting toxicity (DLT) by dose group
Timeframe: 28 days after CAR-T cell infusion
2
Type and incidence of adverse events (AEs) and serious adverse events (SAEs) by dose group
. Subjects have received any anti-cancer treatment as follows:
. Subjects 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 use.
. Subjects with hypertension that cannot be controlled by medication.
. Subjects 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.
. Subjects 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.
. Subjects 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 skin carcinoma, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery.
. Subjects with a history of organ transplantation.