CAR T Cells Targeting CD30 Positive Lymphomas (4SCAR30273)

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Lymphomas

In brief

Currently, a majority of lymphomas cannot be cured by standard chemo-radiotherapy. Cluster of differentiation antigen 30 (CD30) is expressed in many lymphoma subtypes, such as Hodgkin lymphoma (HL) and anaplastic large cell lymphoma (ALCL). CD30 represents a very attractive target for chimeric antigen receptor (CAR)-based immune cell therapy. This study will evaluate a novel 4th generation CD30 CAR engineered with a self-withdrawal mechanism (FKBP-iCasp9) for both efficacy and safety evaluation in lymphoma patients.

Key facts

Study ID

NCT02274584

Run by

Peking University

People needed

20

Starts

2014-03-01

Expected to finish

2017-10-01

Last updated by the study team

2014-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Relapsed or refractory CD30(+) lymphoma patients proved by immuno-histochemistry (IHC) or Flow-cytometry.
• Not eligible for autologous stem-cell transplantation (ASCT) or relapsed after ASCT.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Age≥18.
• Pulse oximetry of > 90% on room air.
• Adequate hepatic function, defined as alanine transaminase (ALT) <3 x upper limit of normal (ULN), aspartate aminotransferase (AST) <3 x ULN; serum bilirubin and alkaline phosphatase <2 x ULN.
• Adequate renal function, defined as serum creatinine <2.0mg/dl.
• Adequate heart function with LVEF≥50%
• Hb≥80g/L
• Measurable disease can be identified.
• Life expectancy ≥3 months.
• Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 1 year after the study is concluded. The male partner should use a condom.
• Patients must sign an informed consent.

You may not qualify if…

• Uncontrolled active infection.
• Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV).
• HIV positive
• Pregnant or lactating.
• Currently enrolled in another clinical trial.
• Concurrent use of systemic steroids.

Where it is running

• University of Florida — Gainesville, Florida, United States (enrolling)
• Peking University Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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