Study Details

Open

Phase Ib/II Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) and CCR4 for Relapsed/Refractory CD30+ Hodgkin s Lymphoma

The purpose of this study is to use the body's own immune cells, modify them, and give them back to you as treatment for your relapsed Hodgkin's Lymphoma.

Age & Gender

3 years ~ 17 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

Your blood will be collected so the process to make the modified study treatment cells can begin. The modified study cells will hopefully be more the study also body's normal cells. The study team will do blood tests and other procedures to confirm it is safe for you to get the modified study cells. If it is safe, you will complete three to four days of pre-treatment that will prepare your body to accept the study cells better. You will then receive the study cell infusion. You will have to stay near the hospital after infusion and will be seen frequently in clinic for follow-up visits that may include lab tests, imaging, or biopsies of your tumor. You will continue follow up visits based on how well you have responded to the study treatment.

In-person visits:
Minimum of 15 clinic visits for the first year, possibly more depending on side effects of treatment (If none, enter

Phone or online visits:
All visits will be done in person unless your Online disease has gotten worse, then you may be contacted by phone for follow-ups

Total length of participation:
year for treatment and initial follow up visits. Up to 15 years for long-term follow up. (Use common blocks of time e.g 4 months insteadof16weeks

Looking for Specific Volunteers

Able to participate:

Subject must have a diagnosis of Classical Hodgkin Lymphoma (Eligibility for specific condition cohort)
Diagnosis of recurrent lymphoma in subjects who have failed ≥ 2 prior treatment
Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the
Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception
Subject is willing to undergo a biopsy prior to treatment, after CAR-T cell infusion, and at the time of progression,

Not eligible if:

If you had major surgery within 28 days to lymphodepletion.
Subject has received chemotherapy orradition therapy within the precvious 3 weeks prior to lymphodepletion
Subject has received anti-CD30 and antibody -based therapy within the previous 3 weeks

Phase Ib/II Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) and CCR4 for Relapsed/Refractory CD30+ Hodgkin s Lymphoma

Age & Gender

Visit Availability

Location

What will be asked of you

Looking for Specific Volunteers

Able to participate:

Not eligible if:

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Additional Study Information

Principal Investigator

Study Type

Study Topics

IRB Number

ClinicalTrials.gov

Helpful Links

Questions?