Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT03765177

Reclutamento in corso

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

Interventistico

Fase 1/2

CancerCare Manitoba

Sponsor: Ottawa Hospital Research Institute

Ultimo Aggiornamento: 14 agosto 2025
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

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.

Mostra Descrizione Dettagliata

Categoria di Trattamento

Altri Farmaci

Mutazioni richieste

CD19

Studio Iniziato

16 ottobre 2019

Ultimo Aggiornamento dello Sponsor

14 agosto 2025

Completamento Stimato

1 gennaio 2027

Contatto dello studio

Nome:Natasha Kekre, MD

Email:nkekre@toh.on.ca

Telefono:613-737-8899

Nome:Anne Marie Clement

Email:amclement@ohri.ca

Telefono:6137378899

Idoneità

Criteri di Inclusione

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

Criteri di Esclusione

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.

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Dettagli del Disegno

AllocazioneN/A

Modello di InterventoSingle Group Assignment

MascheramentoNone (Open Label)

Numero da Arruolare60

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

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

Interventi:

CLIC-1901

Misure di Esito

Misure di Esito Primarie

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

Misure di Esito Secondarie

Nessuno

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Siti dello Studio

Questo studio ha 3 siti

CancerCare Manitoba

Winnipeg, Manitoba, CA

Nome:Chantalle Menard, MD

Non ancora in reclutamento

Winnipeg, Manitoba, R3E 0V9 CA

CancerCare Manitoba

In fase di reclutamento

Ottawa, Ontario, K1H 8L6 CA

The Ottawa Hospital - General Campus

In fase di reclutamento

Vancouver, British Columbia, V5Z1M9 CA

Vancouver General Hospital

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