Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT03765177

Rekrutiert

CLIC-01: CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies

Interventionsstudie

Phase 1/2

CancerCare Manitoba

Sponsor: Ottawa Hospital Research Institute

Zuletzt aktualisiert: 14. August 2025
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

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.

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Andere Medikamente

Erforderliche Mutationen

CD19

Studie gestartet

16. Oktober 2019

Zuletzt vom Sponsor aktualisiert

14. August 2025

Voraussichtlicher Abschluss

1. Januar 2027

Studienkontakt

Name:Natasha Kekre, MD

E-Mail:nkekre@toh.on.ca

Telefon:613-737-8899

Name:Anne Marie Clement

E-Mail:amclement@ohri.ca

Telefon:6137378899

Eignung

Einschlusskriterien

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

Ausschlusskriterien

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.

Glauben Sie, dass diese klinische Studie fälschlicherweise angezeigt wird?

Design-Details

ZuteilungN/A

InterventionsmodellSingle Group Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer60

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung: A single Intravenous infusion of CLIC-1901 will be given.

Interventionen:

CLIC-1901

Ergebnismessungen

Primäre Ergebnismessungen

Proportion of participants experiencing either Grade 3 or 4 cytokine release syndrome.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-19016 months after CAR-T cell infusion

Complete response, partial response and disease progression reviewed 6 months after CAR-T cell infusion

Meeting enrollment targetsFirst 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

Sekundäre Ergebnismessungen

Keine

Studie vormerken

Studie teilen

Studie herunterladen

Glauben Sie, dass diese klinische Studie fälschlicherweise angezeigt wird?

Studie melden

Studie herunterladen

Studienzentren

Diese Studie hat 3 Studienzentren

CancerCare Manitoba

Winnipeg, Manitoba, CA

Name:Chantalle Menard, MD

Rekrutiert noch nicht

Winnipeg, Manitoba, R3E 0V9 CA

CancerCare Manitoba

Rekrutierend

Ottawa, Ontario, K1H 8L6 CA

The Ottawa Hospital - General Campus

Rekrutierend

Vancouver, British Columbia, V5Z1M9 CA

Vancouver General Hospital

Loading Maps...