IRB #

STUDY00019760

Title

A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of
Allogeneic CRISPR-Cas9–Engineered T Cells (CTX110) in Subjects with Relapsed or Refractory
B-Cell Malignancies

Principal Investigator

Richard Maziarz

Study Purpose

The purpose of the study is to learn about the safety and efficacy of CTX110 (study product), an investigational product made from allogeneic T cells that have been modified with gene editing, when infused into patients with Non-Hodgkin lymphoma (NHL). We are hoping to find out if the use of study product in NHL patients is better, worse, or the same as chemotherapy.

Medical Condition(s)

Relapsed or Refractory B Cell Malignancies, B-cell non-hodgkin lmphomas, DLBCL, high grade B cell lymphoma, transformed FL, Richter's transformation of CLL

Eligibility Criteria

- > 18 years of age
- Diagnosed with B-cell non-Hodgkin lymphomas: DLBCL, high grade B-cell lymphoma, transformed follicular lymphoma, grade 2b follicular lymphoma, Richter's transformation of CLL
- Refractory or relapsed disease
- 2 or more prior lines of therapy
- Either have failed autologous HSCT or ineligible for or refused prior autologous HSCT
- Adequate organ function
- No prior CAR T cell therapy
- No prior allogeneic HSCT
- No history of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system involvment
- Patients cannot have unstable angina, clinically significant arrhythmia, or heart attack in the past 6 months
- No presence of bacterial, viral or fungal infection that is uncontrolled or requires IV anti-infectives.
- Women who are pregnant or breastfeeding

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

5 years with the requirement to sign on to a separate long term follow up study for an additional 10 years.

Minors Included

No

Contact

Knight Cancer Intake Center: (503) 494-7999
Clinical Trials Information Line: (503) ­494-­1080 or trials@ohsu.edu

Sponsor

CRISPR Therapeutics

Recruitment End

01/01/2030

Compensation Provided

Yes

Compensation

You will be reimbursed for your study participation, with exact amounts to be determined once the budget has been finalized.

You and your caregiver will receive a debit card that will have money uploaded to it based on the study visits that you complete.


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