CLIC-1901 treatment for relapsed/refractory CD19 positive blood cancers

Canadian-Led Immunotherapies in Cancer: CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies

This study is testing a new treatment called CLIC-1901 for people with hard-to-treat blood cancers to see if it can help them feel better.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (other)
• Drugs / interventions: chemotherapy, CAR-T, Chimeric Antigen Receptor, cyclophosphamide, fludarabine
• Locations: 3 sites (Vancouver, British Columbia and 2 other locations)
• Trial ID: NCT03765177 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of CLIC-1901, an autologous anti-CD19 Chimeric Antigen Receptor T cell therapy, for patients with relapsed or refractory CD19 positive Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma. The study is designed in two stages, starting with a feasibility and safety assessment in 20 participants, followed by an extension phase involving an additional 80 participants to assess overall response rates. Participants will undergo lymphodepletion before receiving a single infusion of CLIC-1901 CAR-T cells. The trial aims to provide insights into the potential benefits of this innovative therapy for difficult-to-treat hematologic malignancies.

Who should consider this trial

Good fit: Ideal candidates include individuals with relapsed or refractory CD19 positive Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma.

Not a fit: Patients with CD19 negative malignancies or those who are not relapsed or refractory may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with relapsed or refractory CD19 positive blood cancers.

How similar studies have performed: Other studies utilizing CAR-T cell therapies have shown promising results, indicating potential success for this approach.

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.

Where this trial is running

Vancouver, British Columbia and 2 other locations

• Vancouver General Hospital — Vancouver, British Columbia, Canada (RECRUITING)
• CancerCare Manitoba — Winnipeg, Manitoba, Canada (NOT_YET_RECRUITING)
• The Ottawa Hospital - General Campus — Ottawa, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Natasha Kekre, MD — Ottawa Hospital Research Isntitute
• Study coordinator: Natasha Kekre, MD

Conditions: Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Chimeric Antigen Receptor T cells, CLIC-1901, anti-CD19 CAR-T cells