Share
Save
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
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-05-26
Primary completion: 2025-08-01
Study completion finish: 2025-09-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT04637763
Intervention or treatment
GENETIC: CB-010
DRUG: Cyclophosphamide
DRUG: Fludarabine
Conditions
- • Lymphoma, Non-Hodgkin
- • Non Hodgkin Lymphoma
- • Lymphoma
- • Relapsed Non Hodgkin Lymphoma
- • Refractory B-Cell Non-Hodgkin Lymphoma
- • B Cell Lymphoma
- • B Cell Non-Hodgkin's Lymphoma
Find a site
Closest Location:
Westmead Hospital
Research sites nearby
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
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
|
EXPERIMENTAL: Expansion of CB-010
| GENETIC: CB-010
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome 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
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!