This study is a single-armed, open-label, multicenter Phase 1/2 study to evaluate the efficacy and safety of CT103A in subjects with relapsed and refractory MM.
Leukapheresis procedure will be performed to manufacture CT103A chimeric antigen receptor (CAR) modified T cells. Bridging therapy is allowed between PBMC collection and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days. After 1-day rest, subjects will receive a single dose infusion of CT103A at 1.0 x 10\^6 CAR+ T cells/Kg. Subjects will be followed in the study for a minimum of 2 years after CT103A infusion. Long-term follow-up for lentiviral vector safety will be followed for up to 15 years after CT103A infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
132
CT103A consists of autologous T lymphocytes transduced with anti-BCMA CAR lentiviral vector that containing a unique CAR structure with a fully human single-chain variable fragment (scFv).
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
RECRUITINGThe Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
Phase 1: Incidence and Severity of Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Minimum of 2 years post CT103A infusion
Phase 1: Laboratoty tests
Abnormal results of laboratoty tests
Time frame: Minimum of 2 years post CT103A infusion
Phase 1: Vital signs
Abnormal results of vital signs
Time frame: Minimum of 2 years post CT103A infusion
Phase 1: Physical examination
Abnormal results of physical examination
Time frame: Minimum of 2 years post CT103A infusion
Phase 2: Overall response rate (ORR) evaluated by an Independent Review Committee (IRC)
Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an IRC
Time frame: 3 months post CT103A infusion
Overall response rate (ORR) evaluated by the investigators
Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigators
Time frame: 3 months post CT103A infusion
Overall Survival (OS)
Time from CT103A infusion to time of death due to any cause
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Zhengzhou, Henan, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
RECRUITINGThe Third Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGJiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGThe Affiliated Hospital of Nanjing University Medical School, Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGThe Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGThe First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGBeijing Boren Hospital
Beijing, China
RECRUITINGPeking University First Hospital
Beijing, China
RECRUITING...and 4 more locations
Time frame: Minimum of 2 years post CT103A infusion
Duration of Response (DOR)
Time from first response evaluated by an IRC or investigators to disease progression or death from any cause
Time frame: Minimum of 2 years post CT103A infusion
Progression-free Survival (PFS)
Time from CT103A infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first
Time frame: Minimum of 2 years post CT103A infusion
Time to Response (TTR)
Time from CT103A infusion to first documentation of response evaluated by an IRC or investigators
Time frame: Minimum of 2 years post CT103A infusion
Laboratoty tests
Abnormal results of laboratoty tests
Time frame: Minimum of 2 years post CT103A infusion
Vital signs
Abnormal results of vital signs
Time frame: Minimum of 2 years post CT103A infusion
Physical examination
Abnormal results of physical examination
Time frame: Minimum of 2 years post CT103A infusion
Minimal Residual Disease (MRD)
Proportion of subjects who achieved MRD negative
Time frame: Minimum of 2 years post CT103A infusion
Pharmacokinetics - Cmax
The maximum transgene level at Tmax
Time frame: Minimum of 2 years post CT103A infusion
Pharmacokinetics - Tmax
Time to peak transgene level
Time frame: Minimum of 2 years post CT103A infusion
Pharmacokinetics - AUC0-28days
Area under the curve of CAR T cells from time zero to Day 28
Time frame: Minimum of 2 years post CT103A infusion
Pharmacokinetics - AUC0-90days
Area under the curve of CAR T cells from time zero to Day 90
Time frame: Minimum of 2 years post CT103A infusion
soluble BCMA levels
soluble BCMA levels in peripheral blood of subjects
Time frame: Minimum of 2 years post CT103A infusion