60 Participants Needed

CLIC-1901 CAR-T Therapy for Blood Cancers

(CLIC-01 Trial)

Recruiting at 2 trial locations
NK
AB
AM
Overseen ByAnne Marie Clement
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Ottawa Hospital Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the trial involves specific treatments like lymphodepletion, it's best to discuss your current medications with the trial team to ensure safety.

What data supports the effectiveness of the CLIC-1901 CAR-T treatment for blood cancers?

CAR-T cell therapies targeting CD19, like CLIC-1901, have shown effectiveness in treating B-cell blood cancers, as seen in the success of similar treatments like CTL019, which received 'breakthrough therapy' designation for its promising results. Additionally, CD19-CAR T cells have been effective in treating B-cell leukemia and lymphoma, indicating potential for CLIC-1901 in similar conditions.12345

What safety data exists for CLIC-1901 CAR-T Therapy for Blood Cancers?

The safety data for CAR-T therapies targeting CD19, like CLIC-1901, show that common side effects include cytokine release syndrome (a condition where the immune system is overly activated) and neurotoxicity (nerve damage), with rates of 33% each. However, a specific study using a similar therapy reported no serious adverse events directly linked to the treatment, and all dose levels were well tolerated.678910

What makes the CLIC-1901 CAR-T treatment unique for blood cancers?

The CLIC-1901 CAR-T treatment is unique because it uses genetically modified T cells to specifically target and attack cancer cells expressing the CD19 protein, which is common in certain blood cancers. This personalized approach harnesses the patient's own immune system to fight the cancer, offering a novel and promising option compared to traditional therapies.1351112

What is the purpose of 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.

Research Team

NK

Natasha Kekre, MD

Principal Investigator

Ottawa Hospital Research Isntitute

Eligibility Criteria

This trial is for adults aged 18-75 with relapsed/refractory CD19+ blood cancers, including certain types of leukemia and lymphoma. Participants must have had a previous relapse or been unresponsive to standard treatments, and show CD19 expression in recent tests. They need good organ function but can't join if they've had gene therapy, certain other conditions or treatments, active infections like HIV/Hepatitis B/C, or are pregnant/nursing.

Inclusion Criteria

My B-cell lymphoma has relapsed twice or more, or didn’t respond to standard treatments.
My leukemia has come back or hasn't responded to treatment.
Provide written informed consent
See 3 more

Exclusion Criteria

I have a genetic condition like Fanconi anemia affecting my bone marrow.
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.
You have had a severe allergic reaction (anaphylaxis) to gentamicin or similar medications.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepletion

Participants undergo lymphodepletion with cyclophosphamide and fludarabine

1 week

Treatment

Single intravenous infusion of CLIC-1901 CAR-T cells

1 day

Initial Follow-up

Participants are monitored for safety and efficacy, focusing on cytokine release syndrome and other toxicities

4 weeks
Multiple visits (in-person)

Extended Follow-up

Participants are monitored for overall response rate, including complete or partial response

6 months

Treatment Details

Interventions

  • CLIC-1901
Trial Overview The study is testing CLIC-1901 CAR-T cell therapy on patients with specific blood cancers who haven't responded well to other treatments. It's given as an IV infusion after pre-treatment with drugs to weaken the immune system (lymphodepletion). The first part checks safety/feasibility in 20 people; the second expands to efficacy/safety in a total of 100 participants.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: CLIC-1901Experimental Treatment1 Intervention
A single Intravenous infusion of CLIC-1901 will be given.

CLIC-1901 is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as CLIC-1901 for:
  • Acute Lymphoblastic Leukemia
  • Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials
585
Recruited
3,283,000+

Findings from Research

CTL019, an anti-CD19 chimeric antigen receptor T-cell therapy, received 'breakthrough therapy' designation from the FDA, marking it as the first personalized cellular therapy for cancer, with over 100 patients treated in clinical trials.
This therapy shows promise for patients with high-risk B-cell malignancies and is part of a growing field, with nearly 30 ongoing clinical trials targeting CD19 and efforts to expand CAR T-cell therapy to other types of cancers.
Going viral: chimeric antigen receptor T-cell therapy for hematological malignancies.Gill, S., June, CH.[2021]
Lenalidomide significantly enhances the effectiveness of CD19-targeted CAR-T cells by improving their differentiation and reducing exhaustion, which leads to better tumor control in various models of diffuse large B-cell lymphoma (DLBCL).
The combination of lenalidomide and CAR-T therapy not only reduces tumor burden but also increases the survival time of mice with DLBCL, suggesting a promising avenue for future clinical trials.
Lenalidomide overcomes the resistance to third-generation CD19-CAR-T cell therapy in preclinical models of diffuse large B-cell lymphoma.Jin, Z., Xiang, R., Qing, K., et al.[2023]
CAR T cell therapy, particularly targeting B cell maturation antigen (BCMA), has shown promising efficacy in early clinical trials for treating multiple myeloma, indicating its potential as a new treatment option.
Recent research has also demonstrated that CAR T cells targeting activated integrin β7 can effectively eliminate multiple myeloma cells, including specific B cell types, and preparations for a clinical trial are underway.
Chimeric antigen receptor T cell therapy for multiple myeloma.Hasegawa, K., Hosen, N.[2020]

References

Going viral: chimeric antigen receptor T-cell therapy for hematological malignancies. [2021]
Lenalidomide overcomes the resistance to third-generation CD19-CAR-T cell therapy in preclinical models of diffuse large B-cell lymphoma. [2023]
Chimeric antigen receptor T cell therapy for multiple myeloma. [2020]
Trispecific CD19-CD20-CD22-targeting duoCAR-T cells eliminate antigen-heterogeneous B cell tumors in preclinical models. [2021]
A phase 1, open-label study of LCAR-B38M, a chimeric antigen receptor T cell therapy directed against B cell maturation antigen, in patients with relapsed or refractory multiple myeloma. [2020]
Anti-CD 19 and anti-CD 20 CAR-modified T cells for B-cell malignancies: a systematic review and meta-analysis. [2023]
FDA Investigating CAR-Related T-cell Malignancies. [2023]
Sleeping beauty generated CD19 CAR T-Cell therapy for advanced B-Cell hematological malignancies. [2023]
Anti-CD19 chimeric antigen receptor-modified T cells for B-cell malignancies: a systematic review of efficacy and safety in clinical trials. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
State of the art in CAR T cell therapy for CD19+ B cell malignancies. [2021]
T-cells fighting B-cell lymphoproliferative malignancies: the emerging field of CD19 CAR T-cell therapy. [2017]
Biology and clinical application of CAR T cells for B cell malignancies. [2023]
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