Research Study Utilizing Expanded Multi-antigen Specific Lymphocytes for the Treatment of Solid Tumors
-
- STATUS
- Recruiting
-
- participants needed
- 32
-
- sponsor
- Children's Research Institute
Holly Meany, MD
Primary Contact
Children's National Medical Center (5.4 mi away) Contact
Summary
Patients with high-risk solid tumors, those that are refractory to standard up front therapy or relapse after completion of therapy, have a very poor prognosis despite attempts to induce remission with salvage regimen. Novel therapies are critical for this patient population with high-risk cancer.
The ability of tumors to be recognized and lysed by the immune system offers a unique opportunity to aid in tumor eradication by expanding and activating these anti-tumor cells. Through this ability to harness sophisticated and specific immunotherapy, residual or relapsed disease that is resistant to chemotherapy and/or radiotherapy could be eradicated. Prior studies have suggested both safety of expanded specific T cells and efficacy in the setting of melanoma, lymphoma or viral eradication. While this therapy has previously been limited by the versatility of the tumor to down-regulate antigens and evade a single immune-target, the use of multi-antigen specific T cells may permit better and more durable anti-tumor immunity. Thus, the investigators propose to infuse these specific multi-antigen anti-tumor T lymphocytes into patients with high risk solid tumors. This trial will be conducted to demonstrate safety of these cells and generate efficacy and biology data that may be important for future studies that may enhance tumor immunotherapy.
Description
This protocol is designed as a phase I dose-escalation study. In each treatment group (A and B), patients will be enrolled to one of the following TAA-CTL dose levels:
Dose Level One: 1 x 107 cells/m2 Dose Level Two: 2 x 107 cells/m2 Dose Level Three: 4 x 107 cells/m2 Two to four patients will be enrolled at each dose level until the maximum tolerated dose (MTD) is determined at which point to ensure safety a total 8 patients will be treated at the MTD. Expansion cohorts of Group B patients with Wilms tumor, neuroblastoma, rhabdomyosarcoma, adenocarcinoma and esophageal cancer will be permitted to enroll up to 6 additional patients in each disease group, to be treated at the MTD. Each patient will receive at least one TAA-CTL infusion and may receive a maximum of 8 doses total. Dose escalation will occur once at least 2 patients have completed the 45 day follow up period following their first TAA-CTL infusion. The first and second doses will be administered 45 days apart then additional doses will be spaced every 28 days. The expected volume of each infusion is 1 to 10 cc.
Patients will receive cells due to the presence of refractory disease and/or high risk for disease relapse and/or residual detectable disease following HSCT or conventional therapy at the time of the infusion. Group A and Group B patients will use the dose escalation strategy described above. Ideally, patients should not receive other systemic antineoplastic agents for at least 45 days after the infusion of TAA- CTL (for purposes of evaluation), although such treatment may be added if deemed critical for patient care by the attending physician.
If patients with measurable or evaluable disease have a response of stable disease or better by RECIST criteria (see section 3.2.1) at the day 28 evaluation after dose 2 or subsequent evaluations they are eligible to receive up to 6 additional doses of CTLs at 28 day intervals. Each subsequent doseis expected to be at the enrollment dose level (i.e. no subsequent dose escalation). Following dose 1, if a patient's T cell supply is insufficient for subsequent doses at the enrollment dose level, further treatments may be administered at a lower dose level at the treating physician's discretion.
Details
| Treatment | Tumor associated antigen lymphocytes (TAA-CTL) |
|---|---|
| Clinical Study Identifier | NCT02789228 |
| Sponsor | Children's Research Institute |
| Last Modified on | 23 January 2021 |
Adding a note
Select a piece of text and start making personal notes.
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer