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RecruitingLast updated: 29 February 2024

ANTLER: This study is evaluating how safe and effective CAR T-cell therapy (called CB-010) is in adults with relapsed or refractory B-cell non-Hodgkin lymphomaA Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma

Clinical summary

Summary

CB-010 is a CRISPR-edited allogeneic CAR T-Cell therapy targeting CD19 - a new form of immunotherapy. Participants will receive CB-010 following lymphodepletion consisting of cyclophosphamide and fludarabine.

This study has two parts.

Part A is a dose escalation following a 3+3 design, with sequential, prespecified, increasing doses. 

Part B is the expansion portion where participants will receive CB-010 at the dose determined in Part A.

 

 

Conditions

This trial is treating patients with non-Hodgkin lymphoma that is relapsed or refractory after prior standard care treatment

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

Trial Acronym

ANTLER

More information

Trial Identifiers

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Trial sponsor

Caribou Biosciences, Inc.

Scientific Title

A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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