CLIC-1901 CAR-T Therapy for Blood Cancers
(CLIC-01 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since the trial involves specific treatments like lymphodepletion, it's best to discuss your current medications with the trial team to ensure safety.
What data supports the effectiveness of the CLIC-1901 CAR-T treatment for blood cancers?
CAR-T cell therapies targeting CD19, like CLIC-1901, have shown effectiveness in treating B-cell blood cancers, as seen in the success of similar treatments like CTL019, which received 'breakthrough therapy' designation for its promising results. Additionally, CD19-CAR T cells have been effective in treating B-cell leukemia and lymphoma, indicating potential for CLIC-1901 in similar conditions.12345
What safety data exists for CLIC-1901 CAR-T Therapy for Blood Cancers?
The safety data for CAR-T therapies targeting CD19, like CLIC-1901, show that common side effects include cytokine release syndrome (a condition where the immune system is overly activated) and neurotoxicity (nerve damage), with rates of 33% each. However, a specific study using a similar therapy reported no serious adverse events directly linked to the treatment, and all dose levels were well tolerated.678910
What makes the CLIC-1901 CAR-T treatment unique for blood cancers?
The CLIC-1901 CAR-T treatment is unique because it uses genetically modified T cells to specifically target and attack cancer cells expressing the CD19 protein, which is common in certain blood cancers. This personalized approach harnesses the patient's own immune system to fight the cancer, offering a novel and promising option compared to traditional therapies.1351112
What is the purpose of this trial?
The investigators propose an early phase study defined as a phase I/II trial assessing safety, feasibility and efficacy of CLIC-1901 autologous anti-CD19 Chimeric Antigen Receptor T cells (CAR-T) cells for participants with relapsed/refractory CD19 positive (CD19+) Acute Lymphoblastic Leukemia (ALL) and non-Hodgkin's Lymphoma (NHL). The Initial Stage of the study (n=20 participants) will focus on feasibility and safety while the Extended Stage will include all participants enrolled in the study (n=additional 80 participants for a total of 100) and will focus on efficacy and safety outcomes. In the proposed trial, we will administer our CAR-T cell product to these participants as a single infusion. Participants will undergo (a) lymphodepletion with cyclophosphamide and fludarabine, followed by (b) infusion of autologous CLIC-1901 CAR-T cells. All treatments will be delivered intravenously.
Research Team
Natasha Kekre, MD
Principal Investigator
Ottawa Hospital Research Isntitute
Eligibility Criteria
This trial is for adults aged 18-75 with relapsed/refractory CD19+ blood cancers, including certain types of leukemia and lymphoma. Participants must have had a previous relapse or been unresponsive to standard treatments, and show CD19 expression in recent tests. They need good organ function but can't join if they've had gene therapy, certain other conditions or treatments, active infections like HIV/Hepatitis B/C, or are pregnant/nursing.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepletion
Participants undergo lymphodepletion with cyclophosphamide and fludarabine
Treatment
Single intravenous infusion of CLIC-1901 CAR-T cells
Initial Follow-up
Participants are monitored for safety and efficacy, focusing on cytokine release syndrome and other toxicities
Extended Follow-up
Participants are monitored for overall response rate, including complete or partial response
Treatment Details
Interventions
- CLIC-1901
CLIC-1901 is already approved in Canada for the following indications:
- Acute Lymphoblastic Leukemia
- Non-Hodgkin's Lymphoma
- Chronic Lymphocytic Leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Hospital Research Institute
Lead Sponsor