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Trial Title:
Safety and Efficacy of Anti-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MM
NCT ID:
NCT05739188
Condition:
Multiple Myeloma in Relapse
Multiple Myeloma, Refractory
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
CAR-T
GPRC5D
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
This is a"3+3"dose escalation study, in which three dose groups are set three different
dose levels of CAR-T cells:
Dose level one: 3.0×10^6 /kg±20%; Dose level two:6.0×10^6 /kg±20%; Dose level
three:1.0×10^7 /kg±20%.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Anti-GPRC5D CAR-T cells infusion
Description:
This is a"3+3"dose escalation study, in which three dose groups are set three different
dose levels of CAR-T cells:
Dose level one: 3.0×10^6 /kg±20%; Dose level two:6.0×10^6 /kg±20%; Dose level
three:1.0×10^7 /kg±20%.
Arm group label:
Anti-GPRC5D CAR-T
Summary:
It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated
trial evaluating the efficacy and safety of anti-GPRC5D CAR-T cells therapy for relapsed
and refractory(r/r) multiple myeloma(MM).
Detailed description:
This open label, single-arm, Phase I study aims to evaluate the efficacy and safety of
Anti-GPRC5D CAR-T in subjects with relapsed and refractory(r/r) multiple myeloma(MM). A
leukapheresis procedure will be performed to manufacture Anti-GPRC5D chimeric antigen
receptor (CAR) modified T cells. Prior to Anti-GPRC5D CAR-T cells infusion subjects will
receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion,
the safety and efficacy of CAR-T therapy was evaluated by investigators.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The patient or his/her guardian understands and voluntarily signs the informed
consent, and is expected to complete the follow-up examination and treatment of the
study procedure;
2. Age 18-75 years old, gender unlimited;
3. Patients diagnosed with multiple myeloma according to International Myeloma Working
Group(IMWG) diagnostic criteria;
4. Subjects who had failed treatment with at least 3 drugs of different mechanisms
(including chemotherapy, proteasome inhibitors, immunomodulators, etc.), or had
progressed or relapsed during the last treatment period or within 6 months after the
end of treatment;
5. The presence of measurable lesions at screening was determined according to any of
the following criteria, defined as: (1) serum monoclonal immunoglobulin (M-protein)
level ≥1.0 g/dL; (2) urine M protein level ≥200 mg/ 24h; (3) Light chain multiple
myeloma diagnosed with no measurable lesion in serum or urine: serum immunoglobulin
free light chain ≥10 mg/dL and serum immunoglobulin κ/γ free light chain ratio
abnormal;
6. The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE
toxicity grade < 2 (unless the abnormality is related to the tumor or is stable as
judged by the investigator and has little impact on safety or efficacy);
7. Eastern cooperative oncology group (ECOG) score is 0-2;
8. Survival is expected to be greater than 3 months;
9. Adequate liver , kidney and cardiopulmonary function;
10. Willingness to complete the informed consent process and to comply with study
procedures and visit schedule.
Exclusion Criteria:
1. Have been diagnosed with or treated for aggressive malignancies other than multiple
myeloma;
2. Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted
therapy, epigenetic therapy, or investigational drug therapy within 14 days or at
least 5 half-lives, whichever is shorter;
3. It is suspected that MM has involved the central nervous system or meninges and has
been confirmed by MRI or CT, or there are other active central nervous system
diseases;
4. Clinically significant central nervous system diseases, such as epilepsy,
cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, psychosis, active
central nervous system involvement or cancerous meningitis;
5. HBsAg or HBcAb are 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 are positive; HIV antibody positive;
Syphilis antibody is positive in the first screening;
6. Pregnant or breastfeeding;
7. Severe active viral, bacterial or uncontrolled systemic fungal infections;
Hereditary bleeding / coagulation diseases, history of non traumatic bleeding or
thromboembolism, other diseases that may increase the risk of bleeding, etc;Patients
who received autologous hematopoietic stem cell transplantation (ASCT) within 8
weeks before screening, or who plan to undergo ASCT during the study period;
8. Any unstable systemic disease: including but not limited to unstable angina,
cerebrovascular accident or transient cerebral ischemia (within 6 months before
screening), myocardial infarction (within 6 months before screening), congestive
heart failure [New York Heart Association (NYHA) classification ≥ grade III], severe
arrhythmia with poor drug control, liver, kidney or metabolic diseases;
9. Had hypersensitivity or intolerance to any drug used in this study;
10. Persons with serious mental illness;
11. Alcoholics or persons with a history of drug abuse;
12. Systemic diseases judged by researchers to be unstable: including but not limited to
severe liver, kidney or metabolic diseases requiring drug treatment;
13. Patients with acute/chronic graft-versus-host disease (GVHD) or requiring
immunosuppressive therapy for GVHD within 6 months prior to screening;
14. Any unsuitable to participate in this trial judged by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Address:
City:
Kunming
Zip:
650100 P.R.China
Country:
China
Status:
Recruiting
Contact:
Last name:
Sanbin Wang, Doctor
Phone:
(+86)13187424131
Email:
Sanbin1011@163.com
Facility:
Name:
No.212 Daguan Road, Xishan District
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Start date:
February 7, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Agency class:
Other
Source:
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05739188
