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CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)

PHASE1RECRUITING

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.

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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.

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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

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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

Condition: Lymphoma, Non-Hodgkin, Non Hodgkin Lymphoma and more
GENETIC: CB-010 and other drugs
Westmead, New South Wales, Australia and more
Sponsor: Caribou Biosciences, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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 Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.	GENETIC: CB-010 CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.
EXPERIMENTAL: Expansion of CB-010 Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.	GENETIC: CB-010 CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.

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

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)