Acute Lymphoblastic LeukemiaPhase 1/2CLIC-01NCT03765177
CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies
A Phase 1/2 study testing CLIC-1901 in people with Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma, run by Ottawa Hospital Research Institute at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia
- What is being tested?
- CLIC-1901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesCanada
- Study dates
- 16 Oct 2019to 30 Jun 2042
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have relapsed or refractory CD19+ disease as defined by one of the following:
- 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
- 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
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
- 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.
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- Presence of active Graft Versus Host Disease requiring systemic therapy.
- 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.
- Active Central Nervous System (CNS) involvement by malignancy, defined by CNS-3 per National Comprehensive Cancer Network guidelines.
- History of anaphylaxis to gentamicin or its derivatives.
- Participant has received an investigational agent within the 30 days prior to enrolment visit.
- Pregnant or nursing women.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Natasha Kekre, MD, MPH, FRCP, 613-737-8899 ext. 71064, nkekre@toh.on.ca
Vanessa Lopez-Ozuna, MD, PhD, 613-737-8899 ext. 71264, vlopez@ohri.ca
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
Kevin Song, MD, 604-875-4863, KSong@bccancer.bc.ca
Claudia Piechnik, BSc, 604-875-4111 ext. 22958, claudia.piechnik@bccancer.bc.ca
- Not yet recruiting
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Chantalle Menard, MD, 2047878687, cmenard@cancercare.mb.ca
About this study
Official title: Canadian-Led Immunotherapies in Cancer: CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies
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.
Read the detailed description
The investigators have designed a two-stage, single-arm, open-label early phase study to determine the safety and efficacy of CLIC-1901 cell therapy in patients with CD19+ ALL and NHL. The primary objective in the initial stage of 20 participants will be to evaluate the feasibility of our protocol and the safety and tolerability of infusing autologous CLIC-1901 cells into patients with relapsed/refractory CD19+ ALL or NHL. Once 20 participants have been treated and the treatment is deemed safe, up to 80 more participants will be enrolled in an extension stage where the primary objective will be overall response rate (defined as complete or partial response) at 6 months after CLIC-1901 infusion.
- Being tested
- CLIC-1901
- Keywords
- Chimeric Antigen Receptor T cells, CLIC-1901, anti-CD19 CAR-T cells
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLIC-1901Biological
Also called autologous anti-CD19 CAR-T cells
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.
| Study group | Role | What they receive |
|---|---|---|
| CLIC-1901 | Experimental | A single Intravenous infusion of CLIC-1901 will be given. Receives: Biological: CLIC-1901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the first 28 days of CAR-T infusion
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
Measured: 6 months after CAR-T cell infusion
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
Measured: First 20 participants within 12 months and next 80 participants within 4 years of opening the second stage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start16 Oct 2019
- Primary completionJan 2027 (estimated)
- Study completion30 Jun 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natasha Kekre, MD, Principal investigator, Ottawa Hospital Research Isntitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765177
- Sponsor's protocol ID
- CLIC-01 Study
- Acronym
- CLIC-01
- Status last verified
- Aug 2025
- First submitted
- 4 Dec 2018
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kekre N, Hay KA, Webb JR, Mallick R, Balasundaram M, Sigrist MK, Clement AM, Nielsen JS, Quizi J, Yung E, Brown SD, Dreolini L, Waller DD, Smazynski J, Gierc NS, Loveless BC, Clark K, Dyer T, Hogg R, McCormick L, Gignac M, Bell S, Chapman DM, Bond D, Yong S, Fung R, Lockyer HM, Hodgson V, Murphy C, Subramanian A, Wiebe E, Yoganathan P, Medynski L, Vaillan DC, Black A, McDiarmid S, Kennah M, Hamelin L, Song K, Narayanan S, Rodrigo JA, Dupont S, Hawrysh T, Presseau J, Thavorn K, Lalu MM, Fergusson DA, Bell JC, Atkins H, Nelson BH, Holt RA. CLIC-01: Manufacture and distribution of non-cryopreserved CAR-T cells for patients with CD19 positive hematologic malignancies. Front Immunol. 2022 Dec 19;13:1074740. doi: 10.3389/fimmu.2022.1074740. eCollection 2022.
PubMed 36601119Castillo G, Lalu M, Asad S, Foster M, Kekre N, Fergusson D, Hawrysh T, Atkins H, Thavorn K, Montroy J, Schwartz S, Holt R, Broady R, Presseau J; GO CART team. Hematologists' barriers and enablers to screening and recruiting patients to a chimeric antigen receptor (CAR) T cell therapy trial: a theory-informed interview study. Trials. 2021 Mar 25;22(1):230. doi: 10.1186/s13063-021-05121-y.
PubMed 33766105Castillo G, Lalu MM, Asad S, Foster M, Kekre N, Fergusson DA, Hawrysh T, Atkins H, Thavorn K, Montroy J, Schwartz S, Holt RA, Broady R, Presseau J. Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial. BMJ Open. 2021 Mar 19;11(3):e043929. doi: 10.1136/bmjopen-2020-043929.
PubMed 33741670Foster M, Fergusson DA, Hawrysh T, Presseau J, Kekre N, Schwartz S, Castillo G, Asad S, Fox G, Atkins H, Thavorn K, Montroy J, Holt RA, Monfaredi Z, Lalu MM. Partnering with patients to get better outcomes with chimeric antigen receptor T-cell therapy: towards engagement of patients in early phase trials. Res Involv Engagem. 2020 Oct 14;6:61. doi: 10.1186/s40900-020-00230-5. eCollection 2020.
PubMed 33072399
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian-Led Immunotherapies in Cancer: CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT03765177
- Acronym / sponsor ID
- CLIC-01 / CLIC-01 Study
- Keywords
- Chimeric Antigen Receptor T cells, CLIC-1901, anti-CD19 CAR-T cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- 30 Jun 2042 (estimated)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators have designed a two-stage, single-arm, open-label early phase study to determine the safety and efficacy of CLIC-1901 cell therapy in patients with CD19+ ALL and NHL. The primary objective in the initial stage of 20 participants will be to evaluate the feasibility of our protocol and the safety and tolerability of infusing autologous CLIC-1901 cells into patients with relapsed/refractory CD19+ ALL or NHL. Once 20 participants have been treated and the treatment is deemed safe, up to 80 more participants will be enrolled in an extension stage where the primary objective will be overall response rate (defined as complete or partial response) at 6 months after CLIC-1901 infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLIC-1901 | Experimental | Biological: CLIC-1901A single Intravenous infusion of CLIC-1901 will be given. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must have relapsed or refractory CD19+ disease as defined by one of the following:
- 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
Key exclusion criteria (12 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLIC-1901Also: autologous anti-CD19 CAR-T cellsParticipants 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. | Biological | CLIC-1901 |
Primary outcome
Proportion of participants experiencing either Grade 3 or 4 cytokine release syndrome.
Time frame: Within the first 28 days of CAR-T infusion
Grade 3 or 4 neurological toxicity, other Grade 3 or 4 toxicity (by CTCAE 4.03) or non-relapse related death.
Proportion of participants with complete (CR) or partial response (PR) to CLIC-1901
Time frame: 6 months after CAR-T cell infusion
Complete response, partial response and disease progression reviewed 6 months after CAR-T cell infusion
Meeting enrollment targets
Time frame: First 20 participants within 12 months and next 80 participants within 4 years of opening the second stage.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Derived from this study: PubMed 36601119Kekre N, Hay KA, Webb JR, Mallick R, Balasundaram M, Sigrist MK, Clement AM, Nielsen JS, Quizi J, Yung E, Brown SD, Dreolini L, Waller DD, Smazynski J, Gierc NS, Loveless BC, Clark K, Dyer T, Hogg R, McCormick L, Gignac M, Bell S, Chapman DM, Bond D, Yong S, Fung R, Lockyer HM, Hodgson V, Murphy C, Subramanian A, Wiebe E, Yoganathan P, Medynski L, Vaillan DC, Black A, McDiarmid S, Kennah M, Hamelin L, Song K, Narayanan S, Rodrigo JA, Dupont S, Hawrysh T, Presseau J, Thavorn K, Lalu MM, Fergusson DA, Bell JC, Atkins H, Nelson BH, Holt RA. CLIC-01: Manufacture and distribution of non-cryopreserved CAR-T cells for patients with CD19 positive hematologic malignancies. Front Immunol. 2022 Dec 19;13:1074740. doi: 10.3389/fimmu.2022.1074740. eCollection 2022.
- Derived from this study: PubMed 33766105Castillo G, Lalu M, Asad S, Foster M, Kekre N, Fergusson D, Hawrysh T, Atkins H, Thavorn K, Montroy J, Schwartz S, Holt R, Broady R, Presseau J; GO CART team. Hematologists' barriers and enablers to screening and recruiting patients to a chimeric antigen receptor (CAR) T cell therapy trial: a theory-informed interview study. Trials. 2021 Mar 25;22(1):230. doi: 10.1186/s13063-021-05121-y.
- Derived from this study: PubMed 33741670Castillo G, Lalu MM, Asad S, Foster M, Kekre N, Fergusson DA, Hawrysh T, Atkins H, Thavorn K, Montroy J, Schwartz S, Holt RA, Broady R, Presseau J. Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial. BMJ Open. 2021 Mar 19;11(3):e043929. doi: 10.1136/bmjopen-2020-043929.
- Derived from this study: PubMed 33072399Foster M, Fergusson DA, Hawrysh T, Presseau J, Kekre N, Schwartz S, Castillo G, Asad S, Fox G, Atkins H, Thavorn K, Montroy J, Holt RA, Monfaredi Z, Lalu MM. Partnering with patients to get better outcomes with chimeric antigen receptor T-cell therapy: towards engagement of patients in early phase trials. Res Involv Engagem. 2020 Oct 14;6:61. doi: 10.1186/s40900-020-00230-5. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natasha Kekre, MD principal investigator
Ottawa Hospital Research Isntitute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CLIC-1901 in people with Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma, run by Ottawa Hospital Research Institute at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natasha Kekre, MD (613-737-8899 ext. 71064, nkekre@toh.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants experiencing either Grade 3 or 4 cytokine release syndrome. (time frame: Within the first 28 days of CAR-T infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03765177, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.