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

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Burkitt lymphoma, HIV, active hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

17 Participants Needed

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).

Research Team

Mark Geyer, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

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%.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

High Dose Chemotherapy and ASCT

Participants receive high-dose chemotherapy followed by autologous stem cell transplantation

4-6 weeks

CAR T-Cell Infusion

Infusion of CAR modified T-cells to determine the maximum tolerated dose

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• 19-28z T CELLS
• Autologous Stem Cell Transplantation
• Carmustine
• Cytarabine
• Etoposide
• Melphalan

Trial Overview 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.

Participant Groups

Group I: HIGH DOSE CHEMOTHERAPY AND ASCT Experimental Treatment 7 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+