Colorectal Cancer Metastatic Clinical Trial
Official title:
A Phase 1/2a, Multicenter, Open-Label, Dose Escalation and Expansion Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Adult Subjects With Metastatic Colorectal Cancer
This study aims to determine the safety and best response of treatment with CNA3103 (Leucine-rich repeat-containing G protein-coupled receptor 5 [LGR5]-targeted, Autologous Chimeric Antigen Receptor (CAR) -T Cells), for participants with Metastatic Colorectal Cancer. Participants may undergo a pre-screening biopsy procedure to determine expression of LGR5. Participants will undergo screening procedures, including leukapheresis (collection of T cells) and lymphodepletion (chemotherapy), up to 47 days prior to CNA3103 dosing. Participants will receive a single Intravenous dose of CNA3103. Expansion cohorts will open after determination of the maximum tolerated dose and recommended phase 2 dose in the dose escalation stage. Participants will be followed up, monitored and will attend study visits for safety and research related tests and procedures for 2 years until disease progression, unacceptable toxicity or intolerable adverse event/s, death or withdrawal of consent.
This is a Phase 1/2a, multicenter, open-label study in adult subjects with metastatic colorectal cancer. (CRC). The study will consist of 2 segments: Phase 1 Segment (Dose Escalation): a Bayesian Optimal Interval (BOIN) study design will be used to minimize any risks of exposure to the novel CNA3103 CAR-T cells during dose escalation while determining the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). A minimum of 3 subjects per cohort will be enrolled at each dose level, with appropriate staggering of subjects within and between dose levels. Phase 2a Segment (Dose Expansion): After determination of the MTD/RP2D, additional subjects will be enrolled and treated with CNA3103 at that dose to further assess the safety, PK, pharmacodynamic, and anti-tumor properties of CNA3103. Based upon safety data of these additional subjects, the Sponsor, in consult with the Investigators, may choose to enroll additional subjects at the same or a different dose. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03941080 -
Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer
|
||
| Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
| Completed |
NCT03647839 -
Modulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synergise With PD1 Inhibition in Microsatellite Stable, Refractory Colorectal Cancer
|
Phase 2 | |
| Recruiting |
NCT05057052 -
Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis
|
Phase 2 | |
| Terminated |
NCT02316496 -
Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study
|
Phase 2 | |
| Completed |
NCT03251612 -
Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
| Completed |
NCT02380443 -
AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer
|
Phase 2 | |
| Recruiting |
NCT02149784 -
Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients
|
Phase 3 | |
| Recruiting |
NCT01959061 -
Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases
|
Phase 4 | |
| Terminated |
NCT01668680 -
Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma
|
Phase 2 | |
| Recruiting |
NCT05068531 -
Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients
|
||
| Not yet recruiting |
NCT04525807 -
Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory
|
||
| Completed |
NCT04482608 -
The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival
|
||
| Recruiting |
NCT03193710 -
The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved
|
N/A | |
| Recruiting |
NCT04854213 -
PRELUDE-1 (Prospective Evaluation of Radiotherapy-induced Biologic Effects in Colorectal Cancer Oligometastatic Patients With LUng-limited Disease: Evolution of Cancer Genetics and Regulatory Immune Cells)
|
N/A | |
| Suspended |
NCT04108481 -
Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT03142516 -
FOLFIRI + Panitumumab First-line Treatment in Elderly Patients With Unresectable Metastatic Colorectal Cancer, RAS/BRAF Wild-type and Good Performance Status
|
Phase 2 | |
| Completed |
NCT03144804 -
A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01910610 -
Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer
|
Phase 3 | |
| Recruiting |
NCT04874207 -
Evaluation of Treatment PERSOnalization Based on Its Therapeutic Monitoring in Patients With Metastatic Colorectal Cancer Treated With REgorafenib
|
Phase 4 |