Loading clinical trials...

To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGEARLY_PHASE1

To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma

Clinical Study to Evaluate the Safety, Tolerability and Initial Efficacy of Anti-GPRC5D-CD19-CAR-T in Patients With Relapsed/Refractory Multiple Myeloma

NCT06298266•Guangdong Second Provincial General Hospital

View on ClinicalTrials.gov

Summary

To evaluate the safety and tolerability of anti-GPRC5D-CD19 CAR-T cells infusion in subjects with relapsed and refractory multiple myeloma

Detailed Description

This study is a single-arm, single-center clinical study of IIT to evaluate the safety, tolerability, pharmacokinetic profile, and initial efficacy of GPRC5D-CD19 CAR T cells in subjects with MM. The safety of GPRC5D-CD19 CAR T was evaluated by observing adverse events after cell therapy. Evaluate the effectiveness of GPRC5D-CD19 CAR T treatment compared to the results of the subjects' own previous standard treatment regimens or base data. Blood and bone marrow were collected before and 24 months after the GPRC5D-CD19 CAR T infusion to detection.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. The patient or their legal guardian understands and voluntarily signs the informed consent form and is expected to complete the follow-up examinations and treatments.
•2\. Age between 18-75 years, regardless of gender. 3. Diagnosed with multiple myeloma according to the IMWG diagnostic criteria, and GPRC5D expression in bone marrow is positive (\>10%).
•4\. Has failed treatment with at least three different mechanisms of drugs (including chemotherapy, proteasome inhibitors, immune modulators, etc.), or has experienced disease progression or relapse within 6 months after the last treatment.
•5\. Measurable lesions are present based on any of the following criteria during screening: (1) Serum monoclonal immunoglobulin (M-protein) level ≥1.0 g/dL; (2) Urine M-protein level ≥200 mg/24 hours; (3) Diagnosed with light chain multiple myeloma with no measurable lesions in serum or urine: Serum free light chain ≥10 mg/dL and abnormal serum free light chain κ/γ ratio.
•6\. The patient has recovered from toxicities associated with previous treatment, i.e., CTCAE toxicity grade \<2 (unless the abnormality is related to the tumor or stable, with no significant impact on safety or efficacy as determined by the investigator).
•7\. ECOG performance status of 0-2 and an expected survival of more than 3 months.
•8\. Adequate organ function:
•Alanine transaminase (ALT) ≤3 times the upper limit of normal (ULN);
•Aspartate transaminase (AST) ≤3 times ULN;
•Total bilirubin ≤1.5 times ULN;
+4 more criteria

Exclusion Criteria

•1\. Diagnosed with or treated for invasive malignant tumors other than multiple myeloma.
•2\. Previously received anti-tumor treatments including targeted therapy, epigenetic therapy, experimental drug therapy, or invasive experimental medical devices within 14 days or at least 5 half-lives (whichever is shorter) before the collection and preparation of CAR-T cells. Also, received monoclonal antibody therapy for relapsed/refractory multiple myeloma within 21 days, received cytotoxic therapy within 14 days, received proteasome inhibitor therapy within 14 days, received immunomodulatory agent therapy within 7 days, or received radiation therapy within 14 days (except for bone marrow reserves with field coverage ≤5%).
•3\. Suspected involvement of multiple myeloma in the central nervous system or meninges confirmed by MRI or CT, or presence of other active central nervous system diseases.
•4\. Screening criteria include plasma cell leukemia (according to standard classification, plasma cells \>2.0×109/L), Waldenstrom macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or secondary AL amyloidosis.
•5\. Positive for hepatitis B surface antigen (HBsAg) and positive for HBV-DNA; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; cytomegalovirus (CMV) DNA test result ≥500 copies/mL; positive for syphilis test.
•6\. Positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; cytomegalovirus (CMV) DNA test result ≥500 copies/mL; positive for syphilis test.
•7\. History of severe allergies defined as grade II or above reactions, with clinical manifestations including airway obstruction (runny nose, coughing, wheezing, difficulty breathing), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), urinary or fecal incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest, or known allergy to any active ingredient, excipient, murine-derived product, or xenogeneic protein contained in this trial (including the CleenRx regimen).
•8\. Severe cardiac diseases including but not limited to severe arrhythmias, unstable angina pectoris, extensive myocardial infarction, New York Heart Association Class III or IV heart failure, myocardial infarction within 6 months before screening or coronary artery bypass graft (CABG), unexplained history of syncope unrelated to vasovagal or dehydration, severe non-ischemic cardiomyopathy, or uncontrolled hypertension (defined as failure to achieve blood pressure goals despite using ≥3 antihypertensive drugs, including diuretics, for ≥1 month or effective blood pressure control requiring ≥4 antihypertensive drugs).
•9\. Unstable systemic diseases, including but not limited to severe liver, kidney, or metabolic diseases requiring medication.
•10\. Acute/chronic graft-versus-host disease (GVHD) within 6 months before screening or patients requiring immunosuppressive therapy for GVHD.
+5 more criteria

Locations (1)

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, China

Key Dates

Start Date

March 29, 2024

Primary Completion Date

May 31, 2026

Completion Date

December 31, 2026

Last Updated

March 7, 2024

Enrollment

ESTIMATED participants

Conditions

Relapsed or Refractory Multiple Myeloma

Interventions

infusion of GPRC5D-CD19 CAR T injection

BIOLOGICAL

Contacts

Qing Zhang

CONTACT

+86 20 8916 8162 zhqing@vip.163.com

A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma

NCT07138209

Relapsed or Refractory Multiple Myeloma

View study

RECRUITINGPHASE1

YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma

NCT05913804

Relapsed or Refractory Multiple Myeloma

View study

RECRUITINGNA

Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma

Inclusion Criteria

Exclusion Criteria

A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma

YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma

Intravenous Autologous CD19 CAR-T Cells for R/ R MM, B-ALL, and B-Cell Lymphoma

Pre-Approval Access Program for Talquetamab in Relapsed or Refractory Multiple Myeloma

A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients