CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine.
Study details:
This clinical trial is a first-in-human, Phase 1, multicenter, open-label evaluation of safety and emerging efficacy of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma. The study is conducted in two parts: Part A is dose escalation following a 3 + 3 design, with sequential, prespecified, increasing doses. Part B is the expansion portion where patients will receive CB-010 at the dose determined in Part A.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Age greater than or equal to 18 at the time of enrollment
- Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate hematologic, renal, liver, cardiac and pulmonary organ function
Exclusion criteria
- Prior therapy with an anti-CD19 targeting agent
- Active or chronic graft versus host disease requiring therapy
- Prior allogeneic stem cell transplantation
- Central nervous system (CNS) lymphoma, prior CNS malignancy
- Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement.
- Primary immunodeficiency
- Current or expected need for systemic corticosteroid therapy
- Current thyroid disorder. Hypothyroidism controlled with stable hormone replacement is permitted
- Other malignancy within 2 years of study entry, except curatively treated malignancies or malignancies with low risk of recurrence
- Unwillingness to follow extended safety monitoring
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT04637763
Intervention or treatment
GENETIC: CB-010
DRUG: Cyclophosphamide
DRUG: Fludarabine
Conditions
- Lymphoma, Non-Hodgkin
- Relapsed Non Hodgkin Lymphoma
- Refractory B-Cell Non-Hodgkin Lymphoma
- Non Hodgkin Lymphoma
- Lymphoma
- B Cell Lymphoma
- B Cell Non-Hodgkin's Lymphoma
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Westmead Hospital
Select from list below to view details:
Westmead Hospital
Westmead, New South Wales, Australia
Epworth Healthcare
Richmond, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
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Who is running the clinical trial?
Caribou Biosciences, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Dose Escalation of CB-010
| Genetic: CB-010, Drug: Cyclophosphamide, Drug: Fludarabine |
EXPERIMENTAL: Expansion of CB-010
| Genetic: CB-010, Drug: Cyclophosphamide, Drug: Fludarabine |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome measures number of patients with dose-limiting toxicities (Part A). | Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion. | 28 days following CB-010 infusion |
| Primary outcome evaluates tumor response (Part B) | The primary endpoint is objective response rate. | Up to 12 months |
Secondary Outcome
References
Clinical Trials Gov: CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)Other trials to consider
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