Study Details

Open

CAR-T Cells in the Treatment of Patients with B Cell Malignancies

In this study, we want to find out if an investigational treatment, P-CD19CD20-ALLO1, is safe and will help treat people with some B-cell malignancies. The study is also being done to determine what dose is tolerated and whether it is effective in treating some B cell malignancies.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

You will undergo screening tests and labs to determine if your cancer has the right characteristics and if you are healthy enough to take part in the study. Once you have passed the screening tests and enroll in the study, you will return for additional visits to confirm you are still eligible. Before receiving the study drug infusion, you will begin a conditioning regimen of 2 chemotherapy drugs for 3 days to prepare your body to receive the study drug. The study drug will be given to you 2 days later via an intravenous (IV) infusion. You will then be assessed during follow-up visits to see the effects of the study drug treatment. Based on the group that you are assigned for the study dose, you might be asked to remain within a 2 hour driving distance from the hospital for 28 days after receiving the study drug infusion.

Incentives

In-person visits:
34 visits for treatment and initial follow up, potentially more for long term follow up

Total length of participation:
Treatment and visits will last for 3 years, long term follow up for 15 years

Looking for Specific Volunteers

Able to participate:

Diagnosis of diffuse large B cell lymphoma, primary mediastinal B cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia
Must have disease that has either not responded to prior treatment or has gotten worse after stopping treatment
If you've had stem cell transplant, at least 90 days have gone by before participation; for CAR-T therapy, at least 4 weeks have gone by
If you experienced any moderate to severe side effects from your last cancer treatment, you must have recovered from those side effects
Must be able to perform activities of self-care and must have adequate bone marrow, liver, and heart function during assessment

Not eligible if:

Have received allogeneic or xenogeneic transplant or allogeneic cellular therapy; have a history of severe reaction (including severe neurotoxic effects) to prior cellular therapy
Have an active malignancy in addition to non-Hodgkin lymphoma or CLL, excluding diseases such as non-metastatic basal cell or squamous cell skin carcinoma
Have active autoimmune disease, such as psoriasis, multiple sclerosis, lupus, rheumatoid arthritis, etc; require medications that suppress your immune system within 2 weeks of treatment
Have history of significant central nervous system disease, such as stroke, epilepsy, etc; patients with CNS metastases or symptomatic central nervous system involvement are excluded
Have history of viral illnesses, including Hepatitis B or C, HIV, HTLV, or other immunodeficiency syndromes; have a positive PCR test for herpes at screening

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

UNC Immunotherapy
UNCImmunotherapy@med.unc.edu

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Natalie Grover
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lymphoma)

IRB Number

23-2028

ClinicalTrials.gov

NCT06014762