Autologous Stem Cell Transplant + CAR T-Cell Therapy for B-Cell Lymphoma

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen ByMark Geyer, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to test the safety of delivering the patients' own immune cells, called T cells, after the high-dose chemotherapy (HDT) and autologous stem cell transplantation (ASCT).

Eligibility Criteria

This trial is for adults over 18 with aggressive B-cell non-Hodgkin lymphoma who've relapsed or are not responding to treatment. They should have a life expectancy of more than 3 months, good kidney and liver function, no severe heart or lung issues, and no other cancers that could interfere with the study. Those previously treated with bone marrow or stem cell transplants, or those with uncontrolled infections including HIV and hepatitis B/C can't participate.

Inclusion Criteria

- Life expectancy of > 3 months.

- Bilirubin < 2.0 mg/100 ml, AST and ALT < 3x the upper limit of normal, PT and PTT < 2x normal outside the setting of stable chronic anticoagulation therapy

My heart is functioning well, with an LVEF greater than 40%.

+5 more

Exclusion Criteria

- Patients with HIV, active hepatitis B, or hepatitis C infection.

I have had cancer before, but it doesn't affect my current study participation.

I have not had a bone marrow or stem cell transplant.

+3 more

Participant Groups

The trial tests high-dose chemotherapy followed by returning patients' own stem cells (ASCT) and then infusing their T-cells modified to target CD19+ B-cells (CAR-T therapy). It aims to see if this combination is safe for treating refractory/relapsed aggressive B-cell non-Hodgkin lymphoma.

1Treatment groups

Experimental Treatment

Group I: HIGH DOSE CHEMOTHERAPY AND ASCTExperimental Treatment7 Interventions

This is a phase 1 dose escalation study designed to determine the maximum tolerated dose (MTD) of CAR modified T cells in patients with relapsed and refractory aggressive B-NHL. Three dose levels (5 x 106 19-28z T cells/kg, 1 x 107 19-28z T cells/kg, and 2 x 107 19-28z T cells/kg) are considered for the MTD.