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Participants with Diffuse Large B-Cell Lymphoma (DLBCL) and large B cell lymphoma for B-Cell Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, NYB-Cell Lymphoma+4 More19(T2)28z1xx TRAC T cell - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will evaluate a new therapy for relapsed/refractory B-cell lymphoma to see if it is safe and effective, and to determine the best dose to use.

Eligible Conditions
  • B-Cell Lymphoma
  • Non-Hodgkin's Lymphoma
  • Diffuse Large B-Cell Lymphoma, Non-Germinal Center B-Cell Subtype
  • Mediastinal Large B Cell Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 0 Secondary · Reporting Duration: up to 1 year

up to 1 year
Maximum tolerated dose (MTD)

Trial Safety

Safety Progress

1 of 3

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Trial Design

1 Treatment Group

Participants with Diffuse Large B-Cell Lymphoma (DLBCL) and large B cell lymphom...
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Participants with Diffuse Large B-Cell Lymphoma (DLBCL) and large B cell lymphoma · No Placebo Group · Phase 1

Participants with Diffuse Large B-Cell Lymphoma (DLBCL) and large B cell lymphoma
Biological
Experimental Group · 1 Intervention: 19(T2)28z1xx TRAC T cell · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year

Who is running the clinical trial?

TakedaIndustry Sponsor
1,134 Previous Clinical Trials
4,062,866 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,846 Previous Clinical Trials
590,036 Total Patients Enrolled
Jae Park, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
13 Previous Clinical Trials
437 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years old.
You have creatinine concentrations lower than or equal to 1.5 mg/100 ml, a creatinine clearance higher than 45ml/min/m2, direct bilirubin levels under 2.0mg/100 ml and AST and ALT values beneath 3.0x the upper limit of normal (ULN).
Your pulmonary function is considered satisfactory, as evidenced by a minimum oxygen saturation of 92% on room air.
You have histologically confirmed DLBCL or large B cell lymphoma including NOS, Transformed DLBCL from follicular lymphoma, High-grade B cell lymphoma (excluding Burkitt's), Primary mediastinal large B cell Lymphoma and are chemotherapy refractory; failed to achieve a partial response within 12 months of the last therapy; progressed/recurred in ≤12 months after prior autologous stem cell transplantation, or relapsed disease after 2+ chemoimmunotherapies with one containing an anthracycline and CD20 directed therapy
References

Frequently Asked Questions

What risks do people with Diffuse Large B-Cell Lymphoma (DLBCL) and large B cell lymphoma face?

"Since this is a Phase 1 trial, with limited data supporting the safety and efficacy of Participants with Diffuse Large B-Cell Lymphoma (DLBCL) and large B cell lymphoma, we gave it a score of 1." - Anonymous Online Contributor

Unverified Answer

What is the cap on the number of participants in this trial?

"Affirmative, the clinicaltrials.gov data indicates that this study is actively seeking enrollees and was originally posted on February 23rd 2023 with a last edit date of February 24th 2023. The trial requires 30 participants to be recruited from one medical facility." - Anonymous Online Contributor

Unverified Answer

Are there any vacant positions for patients within this trial?

"Affirmative. According to clinicaltrials.gov, the trial is actively recruiting participants with its initial posting on February 23rd 2023 and last update made 24 hours later. The single research site requires 30 enrollees for completion of this experiment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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