Active — Not RecruitingPhase 1

A Trial of "Armored" CAR T Cells Targeting CD19 For Patients With Relapsed CD19+ Hematologic Malignancies

United States39 participantsStarted 2017-03-15

Plain-language summary

The purpose of this phase I study is to test the safety of different dose levels of specially prepared cells collected from the patient called "modified T cells". The investigators want to find a safe dose of modified T cells for patients with this type of cancer that has progressed after standard therapy. The investigators also want to find out what effects these modified T cells have on the patient and the cancer. For patients who were treated, had progression of disease and were removed from study, duplicate enrollment is permitted if it is determined the patients could receive a benefit. If the patients meet all eligibility criteria, they can be enrolled onto study a second time as a new accrual, and receive treatment in a higher dose level cohort.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have CD19+ B cell malignancy with relapsed or refractory disease, defined as below: Patients with CLL: * Refractory to or relapsed after at least 2 prior chemo or chemoimmunotherapy (e.g. FCR, BR) requiring further treatment * Refactory to or relapsed after at least 1 prior biologic agent (e.g. Ibrutinib, idelalisib, venetoclax, except a single agent anti-CD20 monoclonal antibody) requiring further treatment Patients with iNHL (FZ, MZL, WM): * Refractory or relapsed after at least 2 lines of chemoimmunotherapy (including at least one course of anti-CD20 antibody) * Refractory or relapsed after at least 1 prior biologic agent (e.g. lenalidomide, ibrutinib, idelalisib) * Patients must have measurable disease (for WM patients, measureable disease is demonstrable monoclonal paraprotein and bone marrow involvement) Patients with DLBCL, Transformed B cell lymphoma, or High grade B cell lymphoma: * Refractory to or relapsed after 1 or more prior chemoimmunotherapies with at least one containing an anthracycline and CD20 directed therapy * Transplant ineligible * Biopsy proven relapsed disease Patients with ALL, CML in lymphoid blast crisis or Burkitt's lymphoma: * Refractory to at least 1 prior induction chemotherapy * Relapsed after at least 1 prior multiagent systemic chemotherapy that included induction and consolidation * Patients with Philadelphia chromosome-positive ALL must have failed a second generation tyrosine kinase inhibitor …

What they're measuring

Maximum tolerated dose (MTD)

Timeframe: occurring within 30 days from the last infusion

Trial details

NCT IDNCT03085173

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03