Status:
RECRUITING
CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Acute Lymphoblastic Leukemia
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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) cell...
Detailed 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 obj...
Eligibility Criteria
Inclusion
- 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
- 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.
- Adequate organ function
- Participant age: 18 to 75 years.
- Provide written informed consent
Exclusion
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Isolated extra-medullary disease.
- Participants with concomitant genetic syndrome, such as Fanconi anemia, Kostmann 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 intent and with no evidence of active disease.
- Prior treatment with any gene therapy product.
- 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.
- Presence of active Graft Versus Host Disease requiring systemic therapy.
- 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.
- History of anaphylaxis to gentamicin or its derivatives.
- Participant has received an investigational agent within the 30 days prior to enrolment visit.
- Pregnant or nursing women.
Key Trial Info
Start Date :
October 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2042
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03765177
Start Date
October 16 2019
End Date
June 30 2042
Last Update
August 14 2025
Active Locations (3)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z1M9
2
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
3
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6