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CAR T-cell Therapy

CRISPR CAR-T Cell Therapy for B-Cell Lymphoma

Phase 1
Recruiting
Research Sponsored by Caribou Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care
Age greater than or equal to 18 at the time of enrollment
Must not have
Central nervous system (CNS) lymphoma, prior CNS malignancy
Prior allogeneic stem cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying a new drug, CB-010, to see if it is safe and effective in treating adults with B cell non-Hodgkin lymphoma that has come back or does not respond to other treatment.

Who is the study for?
Adults over 18 with relapsed/refractory B cell non-Hodgkin lymphoma who've had standard treatments can join. They must be fairly healthy, able to perform daily activities (ECOG status 0 or 1), and have good organ function. Excluded are those needing steroids, with certain neurological or autoimmune diseases, previous anti-CD19 therapy, stem cell transplants, CNS lymphoma/malignancy, primary immunodeficiency, active thyroid disorders (except stable hypothyroidism), and other recent cancers.
What is being tested?
The ANTLER trial is testing CB-010 after a pre-treatment ('lymphodepletion') with fludarabine and cyclophosphamide in adults with advanced B cell non-Hodgkin lymphoma. It aims to assess the safety of this CRISPR-edited CAR-T therapy as well as its potential effectiveness and how the body processes it.
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fever and fatigue (cytokine release syndrome), blood abnormalities, infections due to low blood counts from chemotherapy pre-treatment, allergic reactions during infusion of the CAR-T cells, and organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My non-Hodgkin lymphoma has returned or didn't respond after standard treatment.
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I am 18 years old or older.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had cancer in my brain or spinal cord before.
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I have had a stem cell transplant from a donor.
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I am receiving treatment for ongoing graft versus host disease.
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I need or will need corticosteroid treatment.
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I have a history of seizures, stroke, memory disorders, balance issues, or autoimmune disease affecting my brain.
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I have been treated with a medicine that targets CD19.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
evaluates tumor response (Part B)
measures number of patients with dose-limiting toxicities (Part A).

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Expansion of CB-010Experimental Treatment3 Interventions
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
Group II: Dose Escalation of CB-010Experimental Treatment3 Interventions
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1860

Find a Location

Who is running the clinical trial?

Caribou Biosciences, Inc.Lead Sponsor
3 Previous Clinical Trials
270 Total Patients Enrolled
1 Trials studying Lymphoma
150 Patients Enrolled for Lymphoma

Media Library

CB-010 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04637763 — Phase 1
Lymphoma Research Study Groups: Dose Escalation of CB-010, Expansion of CB-010
Lymphoma Clinical Trial 2023: CB-010 Highlights & Side Effects. Trial Name: NCT04637763 — Phase 1
CB-010 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04637763 — Phase 1
~10 spots leftby Aug 2025
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