CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOttawa Hospital Research Institute
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All eligible participants must have documentation of CD19 tumour expression demonstrated in tissue biopsy, bone marrow or peripheral blood within the 3 months prior to study screening.
Adequate organ function
Participant age: 18 to 75 years.
Provide written informed consent
Disqualifiers
Isolated extra-medullary disease.
Participants with concomitant genetic syndrome, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known familial bone marrow failure syndrome.
Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.
Prior treatment with any gene therapy product.
Trial design
Design model
Single group
Treatments tested in this trial
CLIC-1901
Biological/VaccineParticipants 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: CLIC-1901Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants experiencing either Grade 3 or 4 cytokine release syndrome.
Grade 3 or 4 neurological toxicity, other Grade 3 or 4 toxicity (by CTCAE 4.03) or non-relapse related death.
Time frame
Within the first 28 days of CAR-T infusion2
Proportion of participants with complete (CR) or partial response (PR) to CLIC-1901
Complete response, partial response and disease progression reviewed 6 months after CAR-T cell infusion
Time frame
6 months after CAR-T cell infusion3
Meeting enrollment targets
The feasibility outcome has been met 20 participant in 12 months - currently in next phase and on track to finish on or before October 2024
Time frame
First 20 participants within 12 months and next 80 participants within 4 years of opening the second stage.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov