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

  • STATUS
    Recruiting
  • days left to enroll
    76
  • participants needed
    60
  • sponsor
    Ottawa Hospital Research Institute
Updated on 18 April 2022
cancer
lymphoid leukemia
fludarabine
hematologic malignancy
cyclophosphamide
chronic lymphocytic leukemia
lymphoma
hodgkin's disease
cell transplantation
leukemia
follicular lymphoma
diffuse large b-cell lymphoma
b-cell lymphoma
mantle cell lymphoma
large b-cell lymphoma
salvage therapy
refractory acute lymphoblastic leukemia

Summary

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 40 participants for a total of 60) 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.

Description

The investigators have designed a two-stage, single-arm, open-label early phase study to determine the safety and efficacy of CLIC-1901 cell therapy in patients with CD19+ ALL and NHL. The primary objective in the initial stage of 20 participants will be to evaluate the feasibility of our protocol and the safety and tolerability of infusing autologous CLIC-1901 cells into patients with relapsed/refractory CD19+ ALL or NHL. Once 20 participants have been treated and the treatment is deemed safe, up to 40 more participants will be enrolled in an extension stage where the primary objective will be overall response rate (defined as complete or partial response) at 6 months after CLIC-1901 infusion.

Details
Condition Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia
Treatment CLIC-1901
Clinical Study IdentifierNCT03765177
SponsorOttawa Hospital Research Institute
Last Modified on18 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must have relapsed or refractory CD19+ disease as defined by one of the
following
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
Adequate organ function
demonstrated in tissue biopsy, bone marrow or peripheral blood within the 3
Participant age: 18 to 75 years
months prior to study screening
Provide written informed consent

Exclusion Criteria

Isolated extra-medullary disease
An individual who meets any of the following criteria will be excluded from participation
in this study
Participants with concomitant genetic syndrome, such as Fanconi anemia, Kostmann
Prior treatment with any gene therapy product
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
Presence of active Graft Versus Host Disease requiring systemic therapy
intent and with no evidence of active disease
History of anaphylaxis to gentamicin or its derivatives
Participants with polymerase chain reaction (PCR) positive hepatitis B, hepatitis C
or Human Immunodeficiency Virus (tested within 8 weeks of screening), or any
Pregnant or nursing women
uncontrolled infection at screening
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
Participant has received an investigational agent within the 30 days prior to
enrolment visit
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