Your session is about to expire
← Back to Search
CAR T-cell Therapy
A Study of BCMA/CD19 Dual-Target CAR-T Cell Immunotherapy for Relapsed or Refractory MM
Phase < 1
Waitlist Available
Led By Peihua Lu, PhD&MD
Research Sponsored by Hebei Yanda Ludaopei Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
The study is an early, open, single-centered trial. The aim of this study is to evaluate the safety and tolerance of BCMA/CD19 dual-target CAR-T cell immunotherapy in relapsed or refractory MM. The study will include 18 subjects to receive BCMA/CD19 dual-target CAR-T cell immunotherapy.
Eligible Conditions
- Multiple Myeloma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Type and incidence of dose-limiting toxicity (DLT), incidence and severity of treatment related adverse event (AE), cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome, ICANS) (safety and tolerability)
Secondary study objectives
CAR cells in peripheral blood, bone marrow and CSF (amplification and persistence)
CAR copies in peripheral blood, bone marrow, extramedullary plasmacytoma, and cerebrospinal fluid (CSF) (amplification and persistence)
Concentration of anti-CAR antibody after infusion (humoral immune response)
+4 moreSide effects data
From 2023 Phase 3 trial • 1460 Patients • NCT0414521958%
Oral pruritus
55%
Throat irritation
33%
Ear pruritus
33%
Abdominal pain upper
25%
Nasopharyngitis
21%
Lip swelling
20%
Glossodynia
19%
Nausea
17%
Taste disorder
14%
Mouth swelling
14%
Swollen tongue
13%
Mouth ulceration
13%
Diarrhoea
9%
Pharyngeal swelling
7%
Vomiting
7%
Tongue ulceration
6%
Tooth loss
5%
Bronchitis
5%
COVID-19
5%
Pharyngitis
3%
Upper respiratory tract infection
2%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
HDM SLIT-tablet (12 SQ-HDM)
Placebo SLIT-tablet
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CAR-T treatment groupExperimental Treatment1 Intervention
The patients will receive BCMA/CD19 dual-target CAR-T cell treatment. BCMA/CD19 dual-target CAR-T cell dosage ranges from 2×10\^5 to 1×10\^6 CAR+T/Kg.
Find a Location
Who is running the clinical trial?
Hebei Yanda Ludaopei HospitalLead Sponsor
30 Previous Clinical Trials
1,327 Total Patients Enrolled
3 Trials studying Multiple Myeloma
80 Patients Enrolled for Multiple Myeloma
Gracell Biotechnology Ltd.OTHER
8 Previous Clinical Trials
142 Total Patients Enrolled
1 Trials studying Multiple Myeloma
18 Patients Enrolled for Multiple Myeloma
Peihua Lu, PhD&MDPrincipal InvestigatorHebei Yanda Ludaopei Hospital
8 Previous Clinical Trials
233 Total Patients Enrolled
1 Trials studying Multiple Myeloma
20 Patients Enrolled for Multiple Myeloma