Open for Enrollment Soon
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 surya.nagesh@duke.edu.

Age Group
Adults

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
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon
More Information
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698