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CAR T-cell Therapy

CRX100 for Solid Cancers

Phase 1

Recruiting

Led By Oliver Dorigo, MD

Research Sponsored by BioEclipse Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

iRECIST evaluable disease using computed tomography (CT) or magnetic resonance imaging (MRI) with IV contrast, with at least one measurable target lesion

Histologically-confirmed diagnosis of specific tumors: triple negative adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer, or gastric cancer

Must not have

Clinically significant immunodeficiency in a subject or household contacts

New or progressive brain metastasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after dose administration for each dosed subject.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is safe and effective. The drug will be given to patients with different types of cancer to see if it shrinks their tumors.

Who is the study for?

Adults over 18 with advanced solid tumors like certain breast, colorectal, liver, bone, ovarian or stomach cancers can join. They should be recovered from past treatments and free of active infections. Participants must have measurable cancer on scans and agree to use contraception. Those with recent immunosuppressants, other cancers or treatments, serious illnesses including HIV/hepatitis B/C or brain metastasis cannot join.

What is being tested?

CRX100 is being tested in this phase 1 trial for safety and how the body processes it. It involves taking patients' immune cells out (leukapheresis), treating them to become 'cytokine induced killer cells', then putting them back into the patient to fight cancer.

What are the potential side effects?

Potential side effects are not detailed but may include reactions related to immune system activation such as fever or fatigue due to infusion of modified immune cells (CIK). As a phase 1 trial focuses on safety, close monitoring for any adverse effects is expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer can be measured by scans and has at least one visible tumor.

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My cancer is one of the specified types: triple negative breast, colon, rectum, liver, bone, ovarian, or stomach.

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I haven't received any cellular therapy in the last 12 weeks.

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I am not currently on treatment for any serious infections.

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My condition has not improved with standard treatments, or I cannot tolerate them.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I or someone I live with has a significant immune system problem.

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My cancer has spread to my brain.

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I haven't had chemotherapy in the last 3 weeks.

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I do not have HIV, hepatitis B or C, or any severe illness that could affect my study participation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after dose administration for each dosed subject.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after dose administration for each dosed subject.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after dose administration for each dosed subject. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the maximum tolerated dose (MTD), maximum feasible dose (MFD) or optimal biological dose (OBD) and determine recommended Phase 1b/Phase 2a dose level.

Frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities

Secondary study objectives

Biodistribution of CRX100 based on subject's viral load as assessed through a viral shedding assay.

Early anti-tumor activity of investigational drug based on iRECIST criteria

Immune response to investigational drug based on subject's levels of neutralizing antibodies.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Monotherapy Dose-Escalation CohortsExperimental Treatment3 Interventions

Prior to the current amendment, no DLTs were observed at Dose Levels 1-5. Starting with the current protocol amendment, dosing decisions in monotherapy cohorts will utilize a 3+3 design for Dose Level 6. CRX100 infusion will occur every nine weeks (+/- 7 days). Subjects will receive up to a maximum of four infusions of CRX100 unless it is determined by the treating physician and the sponsor that it is in the best interest of the subjects to receive additional doses of CRX100 beyond four doses. A minimum of three DLT-evaluable subjects will be doses at Dose Level 6 and expanded to six subjects if determined necessary based on DLT incidence using the 3+3 design, and discussion with SRC and Sponsor.

Group II: Combination Therapy CohortsExperimental Treatment3 Interventions

Subjects with relasped or refractory solid tumors, as defined in the inclusion criteria, will be enrolled to evaluate the safety and anti-tumor activity of CRX100 in combination with Pembrolizumab in patients with advanced solid malignancies. The dose of CRX100 used will be determined from the monotherapy cohorts. CRX100 infusion will occur every nine weeks (+/- 7 days). Subjects will receive up to a maximum of four doses of CRX100 unless it is determined by the treating physician and the sponsor that it is in the best interest of the subjects to receive additional doses of CRX100 beyond four doses. Pembrolizumab will be administered at 200mg IV every three weeks (Q3W) per the approved label.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2310