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

Phase 1

Waitlist Available

Led By Craig Sauter, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Bone marrow involvement at the time of relapse or refractory disease and not appropriate for allogeneic transplantation.

- Adequate pulmonary function as assessed by DLCO of ≥ 45% adjusted for hemoglobin

Must not have

- Patients previously treated with autologous or allogeneic bone marrow or stem cell transplantation are ineligible

- Karnofsky performance status ≤ 70 (see appendix VI)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it's safe to give patients their own immune cells after high-dose chemotherapy and autologous stem cell transplantation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to immune cell infusion such as fever, fatigue, blood pressure changes; complications from high-dose chemotherapy like nausea, hair loss; risks associated with stem cell transplant including infection risk due to low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has returned or is not responding to treatment, and I can't have a bone marrow transplant.

Select...

My lung function is good, as shown by a specific breathing test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Select...

I need assistance with my daily activities.

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I do not have any ongoing serious infections.

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I have an aggressive B-cell cancer not listed in the main criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

maximum tolerated dose (MTD)

safety

Side effects data

From 2020 Phase 1 & 2 trial • 34 Patients • NCT02059239

Febrile Neutropenia

Fever

Tumor Lysis Syndrome

Paroxysmal Atrial Tachycardia

Syncope

Heart Failure

Pulmonary Hypertension

Diarrhea

Hypocalcemia

Hypoxia

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Bendamustine

Bendamustine Plus Autologous Transplantation

Bendamustine Plus Allogeneic Transplantation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pegfilgrastim

2013

Completed Phase 3

~4440

Carmustine

1990

Completed Phase 3

~1820