Actively Recruiting
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
1184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must have relapsed or refractory CD19+ disease, including acute lymphoblastic leukemia, chronic lymphocytic leukemia, or B-cell non-Hodgkin's lymphoma.
- Relapsed/refractory disease defined by second or greater relapse, relapse after stem cell transplantation, or chemorefractory status.
- Documentation of CD19 tumor expression within 3 months prior to screening.
- Adequate organ function.
- Age between 18 and 75 years.
- Provide written informed consent.
You will not qualify if you...
- Isolated extra-medullary disease.
- Presence of genetic syndromes like Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other familial bone marrow failure syndromes.
- Prior malignancy except treated carcinoma in situ of skin or cervix with no active disease.
- Prior treatment with any gene therapy product.
- Positive PCR for hepatitis B, hepatitis C, or HIV within 8 weeks of screening or uncontrolled infection.
- Active Graft Versus Host Disease requiring systemic therapy.
- Allogeneic stem cell transplantation less than 6 months prior or donor lymphocyte infusion less than 6 weeks prior to CAR-T infusion.
- Active central nervous system involvement by malignancy.
- History of anaphylaxis to gentamicin or derivatives.
- Receipt of 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
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
Research Team
N
Natasha Kekre, MD
CONTACT
A
Anne Marie Clement
CONTACT
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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