CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies (CLIC-01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03765177|
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : April 6, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia||Biological: CLIC-1901||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Canadian-Led Immunotherapies in Cancer: CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies|
|Actual Study Start Date :||October 16, 2019|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 31, 2022|
A single Intravenous infusion of CLIC-1901 will be given.
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.
Other Name: autologous anti-CD19 CAR-T cells
- 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 ]
- Meeting enrollment targets [ Time Frame: First 20 participants within 12 months and next 40 participants within 2 years of opening the second stage. ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765177
|Contact: Natasha Kekre, MD||613-737-8899 ext firstname.lastname@example.org|
|Contact: Alice Black||613-737-8899 ext email@example.com|
|Canada, British Columbia|
|Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V5Z1M9|
|Contact: Kevin Hay, MD 604-675-8266 Kevin.Hay@bccancer.bc.ca|
|Contact: Justine Dimou, BSc 604-875-4111 ext 61971 firstname.lastname@example.org|
|The Ottawa Hospital - General Campus||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: Natasha Kekre, MD, MPH, FRCP 613-737-8899 ext 71064 email@example.com|
|Contact: Alice Black 613-737-8899 ext 71064 firstname.lastname@example.org|
|Responsible Party:||Ottawa Hospital Research Institute|
|Other Study ID Numbers:||
|First Posted:||December 5, 2018 Key Record Dates|
|Last Update Posted:||April 6, 2022|
|Last Verified:||March 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Chimeric Antigen Receptor T cells
anti-CD19 CAR-T cells
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Immune System Diseases
Neoplasms by Site