CompletedPhase 1

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

China13 participantsStarted 2019-08-20

Plain-language summary

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

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. The patient volunteered to participate in the study, and signed the Informed Consent
✓. Age 18-70 years old, male or female
✓. Patients with CD20+ DLBCL (including PMBCL and tFL), FL and MCL, at least one measurable lesion (LDi≥ 1.5 cm)
✓. r/r lymphoma patients who received prior CD19 CAR-T therapy
✓. At least one week from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
✓. No immunosuppressive therapy was used within 1 week before C-CAR066 infusion
✓. No mAb treatment within 2 weeks before C-CAR066 infusion
✓. Adequate organ and bone marrow function

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 immunosuppressor
✕. 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 apheresis
✕. HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers

What they're measuring

Incidence of adverse events

Timeframe: Up to 12 weeks after C-CAR066 infusion

Trial details

NCT IDNCT04036019

SponsorShanghai Tongji Hospital, Tongji University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-20

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