CompletedPhase 1

A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy

China7 participantsStarted 2019-09-29

Plain-language summary

This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r DLBCL who received CD19 CAR-T therapy.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. The patient volunteered to participate in the study, and signed the Informed Consent
✓. Age 18-75 years old, male or female
✓. Patients diagnosed with diffuse large B-cell lymphoma (DLBCL, De novo or transformed) histologically according to the 2016 WHO Classification, at least one measurable lesion(LDi≥1.5 cm)
✓. r/r DLBCL patients who received prior CD19 CAR-T therapy, and positive for CD20
✓. At least 2 weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
✓. Adequate organ and bone marrow fuction
✓. No contraindications of apheresis
✓. Expected survival time \> 3 months

Exclusion criteria

✕. Have a history of allergy to cellular products
✕. Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard
✕. A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease
✕. Patients with active CNS involvement
✕. Patients with autoimmune disease, immunodeficiency, or other treatment requiring inhibitors
✕. Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed
✕. Live vaccination within 4 weeks before peripheral blood apheresis
✕. HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers

What they're measuring

The incidence of adverse events

Timeframe: Up to 12 weeks after C-CAR066 infusion

Trial details

NCT IDNCT04316624

SponsorInstitute of Hematology & Blood Diseases Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-08

View on ClinicalTrials.gov More Diffuse Large B Cell Lymphoma trials