CLIC-01: Manufacture and distribution of non-cryopreserved CAR-T cells for patients with CD19 positive hematologic malignancies.
Natasha Kekre, Kevin A Hay, John R Webb...
https://pubmed.ncbi.nlm.nih.gov/36601119Actively Recruiting
Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
ID03765177
CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies
Led by Ottawa Hospital Research Institute · Updated on 2025-08-14
60
Participants Needed
3
Research Sites
808 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and effectiveness of CLIC-1901 autologous anti-CD19 CAR-T cells in patients with relapsed or refractory CD19-positive Acute Lymphoblastic Leukemia (ALL) and Non-Hodgkin's Lymphoma (NHL). This early phase I/II trial includes an initial stage focusing on safety and feasibility in 20 participants, followed by an extended stage enrolling up to 100 participants to assess treatment response. The study aims to better understand how this therapy works for participants with these blood cancers. Participants will receive a single intravenous infusion of CLIC-1901 CAR-T cells after undergoing lymphodepletion with cyclophosphamide and fludarabine. The treatment is delivered intravenously, and the study is designed as a two-stage, single-arm, open-label trial. The initial 20 participants will focus on safety and tolerability, and upon successful completion, up to 80 additional participants will be enrolled to evaluate the overall response rate at six months. During the study, participants will be closely monitored for safety, including the occurrence of severe cytokine release syndrome within the first 28 days after infusion. Researchers will assess treatment response at six months and track enrollment progress. Participants must attend study visits for evaluations, including tissue biopsies, blood tests, and clinical assessments. The total duration of participation depends on the stage of enrollment and follow-up requirements, with safety and efficacy outcomes guiding the study progress.
CONDITIONS
Brief Title
CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with relapsed or refractory CD19 positive acute lymphoblastic leukemia, chronic lymphocytic leukemia, or B-cell non-Hodgkin's lymphoma
- Documentation of CD19 tumor expression from tissue biopsy, bone marrow, or peripheral blood within 3 months prior to screening
- Adequate organ function
- Provide written informed consent
You will not qualify if you...
- Isolated extra-medullary disease
- Genetic syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other familial bone marrow failure syndromes
- Prior malignancy except treated carcinoma in situ of the skin or cervix with no active disease
- Prior treatment with any gene therapy product
- Positive PCR test for hepatitis B, hepatitis C, or HIV within 8 weeks of screening, or any uncontrolled infection
- Active Graft Versus Host Disease requiring systemic therapy
- Allogeneic stem cell transplant less than 6 months prior to infusion or donor lymphocyte infusion less than 6 weeks prior
- Active central nervous system involvement by malignancy
- History of anaphylaxis to gentamicin or derivatives
- Received investigational agent within 30 days prior to enrollment
- Pregnant or nursing women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Lymphodepletion and Treatment
Duration - Up to 28 days
Participants receive lymphodepletion chemotherapy followed by a single intravenous infusion of autologous CLIC-1901 CAR-T cells.
1 to 2 visits around infusion
Follow-up and Response Assessment
Duration - 6 months
Participants are monitored to assess safety and treatment response, including evaluation of cytokine release syndrome and tumor response at 6 months after infusion.
Regular visits during first month and periodic visits up to 6 months
Trial Site Locations
Total: 3 locations
1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z1M9
Actively Recruiting
2
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Not Yet Recruiting
3
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
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Research Team
N
Natasha Kekre, MD
A
Anne Marie Clement
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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