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This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

CRSP-ONC_001 _PhI_allo_ CART_NHL (B Cell Cancers) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called CTX110 (the study drug) is a safe and effective treatment for people with B cell cancers.

What is the Condition Being Studied?

B Cell Cancers (NHL, B-ALL)

Who Can Participate in the Study?

Adults diagnosed with B cell cancers who:
- Have relapsed from previous treatment; OR
- Did not have an adequate response to standard treatments

For more information about who can join this study, please contact the study team at

Age Group

What is Involved?

If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
- Have a physical exam
- Have a heart scan (ECG)
- Have blood draws and give urine samples
- Have bone marrow samples taken
- Have images taken (X-ray or CT scan)
- Have a Lumbar puncture/tumor biopsy

If you are eligible to continue after screening, you will be scheduled for a procedure called leukapheresis to collect some of your white blood cells. Once your cells are collected, they will be sent to be genetically modified with CRISPR/Cas9 to become activated and turned into the study drug.

Before you get the study drug by intravenous (IV) infusion, you will receive a 3-day course of lymphodepleting chemotherapy (a combination of fludarabine and cyclophosphamide). You may also get a dose of a chemotherapy called daratumumab up to 5 days before the LD chemotherapy, and may continue to receive it monthly (up to 3 doses).

This study is divided into 2 different parts, Part A and Part B:
- During Part A, increasing doses of the study drug will be given to participants
- During Part B, a fixed dose of the study drug will be given to participants based on the results of Part A

Whether you are in Part A or Part B will depend on when you join the study.

Once you stop taking the study drug, you will enter a follow-up period. During this period, you will visit our clinic over 5 years according to the following schedule:
- Weekly for the first month
- Every 30 days for months 2-3
- Every 3 months until month 18
- Every 6 months from Months 24 to 60

Study Details

Full Title
A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9?Engineered T Cells (CTX110) in Subjects With Relapsed or Refractory B Cell Malignancies
Principal Investigator
Cellular Therapy Specialist
Protocol Number
IRB: PRO00106428
NCT: NCT04035434
Phase I
Enrollment Status
Open for Enrollment Soon
More Information
Contact the Duke Recruitment Innovation Center