NCT03765177 CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies
| NCT ID | NCT03765177 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2019-10-16 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2019-10-16 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Participant must have relapsed or refractory CD19+ disease as defined by one of the following: a. Relapsed or refractory acute lymphoblastic leukemia or chronic lymphocytic leukemia as defined by one of the following: i. Second or greater relapse ii. Any relapse after allogeneic stem cell transplantation (SCT) iii. Chemorefractory as defined by not achieving CR after 2 cycles of a standard induction chemotherapy or one cycle of salvage therapy b. Histologically confirmed B-cell non-Hodgkin's lymphoma including but not limited to diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, or transformed follicular lymphoma, Richter's, Burkitt's or Mantle Cell lymphoma with one of the following: i. Second or greater relapse ii. Any relapse after autologous or allogeneic SCT iii. Chemorefractory as defined by not achieving CR after 2 cycles of a standard chemotherapy or one cycle of salvage therapy 2. 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. 3. Adequate organ function 4. Participant age: 18 to 75 years. 5. Provide written informed consent Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Isolated extra-medullary disease. 2. Participants with concomitant genetic syndrome, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known familial bone marrow failure syndrome. 3. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease. 4. Prior treatment with any gene therapy product. 5. Participants with polymerase chain reaction (PCR) positive hepatitis B, hepatitis C, or Human Immunodeficiency Virus (tested within 8 weeks of screening), or any uncontrolled infection at screening. 6. Presence of active Graft Versus Host Disease requiring systemic therapy. 7. Participants who have undergone allogeneic SCT less than 6 months prior to CLIC-1901 cell infusion or who have undergone donor lymphocyte infusion less than 6 weeks prior to CLIC-1901 cell infusion. 8. Active Central Nervous System (CNS) involvement by malignancy, defined by CNS-3 per National Comprehensive Cancer Network guidelines. 9. History of anaphylaxis to gentamicin or its derivatives. 10. Participant has received an investigational agent within the 30 days prior to enrolment visit. 11. Pregnant or nursing women.
Contact & Investigator
Natasha Kekre, MD
PRINCIPAL INVESTIGATOR
Ottawa Hospital Research Isntitute
Frequently Asked Questions
Who can join the NCT03765177 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03765177 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03765177 currently recruiting?
Yes, NCT03765177 is actively recruiting participants. Contact the research team at nkekre@toh.on.ca for enrollment information.
Where is the NCT03765177 trial being conducted?
This trial is being conducted at Vancouver, Canada, Winnipeg, Canada, Ottawa, Canada.
Who is sponsoring the NCT03765177 clinical trial?
NCT03765177 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Natasha Kekre, MD at Ottawa Hospital Research Isntitute. The trial plans to enroll 60 participants.
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