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Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) for Diffuse Intrinsic Pontine Glioma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Diffuse Intrinsic Pontine Glioma+4 MoreTumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) - Biological
Eligibility
1 - 30
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new cancer treatment that uses molecular targeted therapy in combination with adoptive cell therapy. The goal is to find the maximum tolerated dose and to evaluate the safety and feasibility of this new treatment.

Eligible Conditions
  • Diffuse Intrinsic Pontine Glioma
  • Neuroblastoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 7 years

2 years
Determine the Overall Response Rate (ORR) of Participants using INSS Response Evaluation Criteria for NB and RANO criteria for DIPG
Number of Participants that are able to have vaccine produced and delivered
Number of Participants with Dose Limiting Toxicities as a Measure of Safety and Tolerability
Year 2
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
7 years
Number of participants with overall survival (OS) during study
Number of participants with progression free survival (PFS) during study

Trial Safety

Safety Progress

1 of 3

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1
BXQ-350 - Part 1 Dose Escalation: Safety and Tolerance
1
Td vaccine
1
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Trial Design

2 Treatment Groups

Arm 2: Relapsed/Refractory Neuroblastoma (NB)
1 of 2
Arm 1: Subjects with Diffuse Intrinsic Pontine Glioma (DIPG).
1 of 2

Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) · No Placebo Group · Phase 1

Arm 2: Relapsed/Refractory Neuroblastoma (NB)
Biological
Experimental Group · 1 Intervention: Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) · Intervention Types: Biological
Arm 1: Subjects with Diffuse Intrinsic Pontine Glioma (DIPG).
Biological
Experimental Group · 1 Intervention: Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 7 years

Who is running the clinical trial?

Giselle SaulnierShollerLead Sponsor
21 Previous Clinical Trials
2,192 Total Patients Enrolled
University of FloridaOTHER
1,249 Previous Clinical Trials
698,669 Total Patients Enrolled
1 Trials studying Diffuse Intrinsic Pontine Glioma
21 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Wake Forest University Health SciencesLead Sponsor
1,122 Previous Clinical Trials
1,127,018 Total Patients Enrolled
Giselle Sholler, MDStudy ChairBeat Childhood Cancer at Atrium Health
16 Previous Clinical Trials
1,919 Total Patients Enrolled
Sri Gururangan, FRCPStudy ChairUniversity of Florida
Duane Mitchell, M.D., Ph.D.Study ChairUniversity of Florida

Eligibility Criteria

Age 1 - 30 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People with a disease that can be measured, as defined in section 8, and a tumor that is accessible for biopsy, can participate in this study if the tumor tissue is >30% viable
You must be 12 months or older at the time of enrollment.
Newly-diagnosed cancer patients are often willing to undergo a biopsy to determine the type of cancer they have and the best treatment plan.
The person must be within two months of diagnosis and prior to starting radiation therapy.
The child must be at least three years old to participate in this study.
People who have had a relapse after trying standard treatments, or those who have not responded to standard treatments and are getting worse, may be candidates for experimental treatments.
(DIPG) is a rare, high-grade tumor that arises from cells in the brain stem
All subjects must be aged 30 or younger at the time of enrollment.
We need someone who is willing to consent to a biopsy so that we can confirm the tumor's identity and extract its RNA for further testing.
References

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