CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes for Mantle Cell Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mantle Cell Lymphoma+1 MoreCD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes - Biological
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is investigating the side effects and efficacy of CD19 CAR T cells and acalabrutinib in treating patients with mantle cell lymphoma.

Eligible Conditions
  • Mantle Cell Lymphoma

Treatment Effectiveness

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Up to 15 year post CAR T cell infusion

At 28 days
CD19 CAR T cell persistence
Day 28
Occurrence of dose-limiting toxicities (DLTs) (Safety Lead-in)
Year 1
Overall survival (OS)
Year 1
Progression-free survival (PFS)
Year 15
Duration of CR
Time to CR
Year 1
Best response
Presence of CD19CAR immunogenicity
Year 15
Incidence of adverse events
Year 15
Duration of CR from completion of acalabrutinib
Month 6
Complete response (CR) (Phase II)

Trial Safety

Trial Design

1 Treatment Group

Treatment (CD19 CAR T cells, acalabrutinib)
1 of 1

Experimental Treatment

36 Total Participants · 1 Treatment Group

Primary Treatment: CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes · No Placebo Group · Phase 2

Treatment (CD19 CAR T cells, acalabrutinib)Experimental Group · 2 Interventions: CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes, Acalabrutinib · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 year post car t cell infusion

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
515 Previous Clinical Trials
2,248,044 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,072 Previous Clinical Trials
41,128,882 Total Patients Enrolled
Lihua E BuddePrincipal InvestigatorCity of Hope Comprehensive Cancer Center
1 Previous Clinical Trials
18 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to understand and you are willing to sign a written informed consent.
If available, exceptions may be granted with study principal investigator (PI) approval.
You have failed at least 1 prior regimen before acalabrutinib.
No contraindications to leukapheresis, steroids or tocilizumab.
You have a total serum bilirubin level of 2.
You have not received treatment with acalabrutinib for more than 4 weeks prior to screening.