huCART19-IL18 for Chronic Lymphocytic Leukemia

University of Pennsylvania, Philadelphia, PA

Chronic Lymphocytic Leukemia+2 More ConditionshuCART19-IL18 - Biological

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial is testing how safe it is to give people higher doses of a new cancer treatment.

Eligible Conditions

Chronic Lymphocytic Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Phase 1

Similar Trials

1

Single arm study

1

1

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: 12 months

1 months

Overall Remission Rate (ORR).

12 months

Characterize low level disease and B cell assessment in response to huCART19-IL18 cells

Duration of Response (DOR)

Event Free Survival (EFS)

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0.

Number of subjects who have a response

Overall Survival (OS)

Progression free survival (PFS)

3 months

Determination of Maximum Tolerated Dose (MTD)

Occurrence of dose-limiting toxicities (DLTs).

Overall Response Rate (ORR).

Percentage of manufacturing products that meet release criteria.

6 months

Best Overall Response (BOR)

Trial Safety

Phase-Based Safety

1 of 3

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1

Single arm study

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Awards & Highlights

No Placebo Group

All patients enrolled in this trial will receive the new treatment.

Trial Design

24 Treatment Groups

NHL Dose Level 1b (DL1b)

1 of 24

ALL Dose Level 1b (DL1b)

1 of 24

NHL Dose Level 4 (DL4)

1 of 24

CLL Dose Level 2 (DL2)

1 of 24

ALL Dose Level 3 (DL3)

1 of 24

NHL Dose Level 2 (DL2)

1 of 24

ALL Dose Level 5 (DL5)

1 of 24

NHL Dose Level 5 (DL5)

1 of 24

CLL Dose Level 1b (DL1b)

1 of 24

ALL Dose Level 4 (DL4)

1 of 24

CLL Dose Level 5 (DL5)

1 of 24

CLL Dose Level 3 (DL3)

1 of 24

CLL Dose Level 4 (DL4)

1 of 24

NHL Dose Level 1a (DL1a)

1 of 24

NHL Dose Level -1 (DL-1)

1 of 24

ALL Dose Level 2 (DL2)

1 of 24

NHL Dose Level 3 (DL3)

1 of 24

Dose Level 1a (DL1a)

1 of 24

Dose Level -1 (DL-1)

1 of 24

Dose Level 1b (DL1b)

1 of 24

Dose Level 2 (DL2)

1 of 24

Dose Level 3 (DL3)

1 of 24

Dose Level 4 (DL4)

1 of 24

Dose Level 5 (DL5)

1 of 24

Experimental Treatment

72 Total Participants · 24 Treatment Groups

Primary Treatment: huCART19-IL18 · No Placebo Group · Phase 1

NHL Dose Level 1b (DL1b)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

ALL Dose Level 1b (DL1b)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

NHL Dose Level 4 (DL4)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

CLL Dose Level 2 (DL2)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

ALL Dose Level 3 (DL3)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

NHL Dose Level 2 (DL2)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

ALL Dose Level 5 (DL5)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

NHL Dose Level 5 (DL5)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

CLL Dose Level 1b (DL1b)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

ALL Dose Level 4 (DL4)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

CLL Dose Level 5 (DL5)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

CLL Dose Level 3 (DL3)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

CLL Dose Level 4 (DL4)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

NHL Dose Level 1a (DL1a)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

NHL Dose Level -1 (DL-1)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

ALL Dose Level 2 (DL2)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

NHL Dose Level 3 (DL3)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

Dose Level 1a (DL1a)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

Dose Level -1 (DL-1)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

Dose Level 1b (DL1b)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

Dose Level 2 (DL2)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

Dose Level 3 (DL3)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

Dose Level 4 (DL4)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

Dose Level 5 (DL5)

Biological

Experimental Group · 1 Intervention: huCART19-IL18 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: 12 months

Who is running the clinical trial?

University of Pennsylvania

University of PennsylvaniaLead Sponsor

1,897 Previous Clinical Trials

41,217,851 Total Patients Enrolled

Jakub Svoboda, MDPrincipal InvestigatorUniversity of Pennsylvania

5 Previous Clinical Trials

76 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

References

2021. "huCART19-IL18 in CD19+ Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04684563.

Frequently Asked Questions

How many participants have been recruited for this research endeavor?

"Confirmed. According to clinicaltrials.gov, this medical research project is actively recruiting participants, having first been posted on May 6th 2021 and most recently edited on October 31st 2022. The study seeks 30 enrollees at a single site of operation." - Anonymous Online Contributor

Unverified Answer

Is there a call for volunteers at this time to participate in the clinical trial?

"Affirmative. Records on clinicaltrials.gov demonstrate that this healthcare trial, which was first posted on May 6th 2021, is still in the process of recruiting patients. Approximately 30 individuals are required to be recruited from 1 site." - Anonymous Online Contributor

Unverified Answer

Has the FDA authorized huCART19-IL18 for medicinal use?

"The safety of huCART19-IL18 was conservatively estimated at a score of 1 due to the nature of Phase 1 trials, which only have limited data supporting efficacy and safety." - 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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