ACTolog in Patients With Solid Cancers



Status:Recruiting
Conditions:Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 65
Updated:1/23/2019
Start Date:June 30, 2017
End Date:September 2019
Contact:Rebecca Griffith-Eskew
Email:griffith-eskew@immatics.com
Phone:346-204-5359

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Phase I Adoptive Cellular Therapy Trial With Endogenous CD8+ T Cells (ACTolog® IMA101) Alone or in Combination With Atezolizumab in Patients With Relapsed and/or Refractory Solid Cancers

The study purpose is to learn about the safety and tolerability of IMA101 alone (Cohort 1) or
in combination with atezolizumab (Cohort 2) in patients with advanced solid cancers.

SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) and the
main biomarkers screening. If the patient is eligible, white blood cells will be collected
with a leukapheresis for the manufacture of the IMA101 product.

MANUFACTURE: IMA101 product will be made from the patient's white blood cells.

TREATMENT: IMA101 product will be administered to the patient intravenously after
lymphodepleting pre-conditioning with chemotherapy (fludarabine and cyclophosphamide).

Low-dose IL-2 will be self-administered twice daily for a total of 28 doses after infusion of
IMA101 product. In Cohort 2, atezolizumab will be administered every 3 weeks, starting no
earlier than 3 weeks after the IMA101 product infusion and after hematologic recovery.

Patients will be monitored closely throughout the study.

Inclusion Criteria:

1. Patients must have pathologically confirmed advanced/metastatic cancer prior to
enrollment.

2. HLA phenotype positive.

3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

4. Life expectancy > 6 months prior to enrollment.

5. Patient is a candidate for a maximum of one further line of established therapy (prior
to treatment with ACTolog).

6. The patient has adequate organ and marrow function per protocol

7. At least one lesion (metastasis or primary tumor) being considered accessible by
non-high-risk collection procedures for biopsy.

8. The patient has adequate hepatic function per protocol

9. The patient has serum creatinine clearance ≥50 mL/min by the Cockcroft-Gault formula.

10. The patient has adequate pulmonary function per protocol and oxygen saturation >92% on
room air.

11. Acceptable coagulation status: INR ≤2.0 x ULN and PTT ≤2.0 x ULN.

12. Women of childbearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the duration
of study participation.

13. Male subjects must agree to use effective contraception or abstinence while on study
and for 90 days after infusion of the ACTolog T-cell product.

14. Ability of subject to understand and the willingness to sign written informed consent
for study participation.

15. Confirmed availability of production capacities for the patient's ACTolog products.

16. ACTolog target expression as evaluated by the in vitro diagnostic device IMA_Detect:
Patient's tumor must express at least one ACTolog target as assessed by quantitative
PCR (qPCR) (to be assessed from a tumor biopsy to be performed if all other
eligibility criteria are met).

Exclusion Criteria

1. Any condition contraindicating leukapheresis.

2. Patients with brain metastases. Patients with a history of brain metastases may be
eligible, if an imaging scan with contrast enhancement not older than 4 weeks is able
to exclude the existence of currently active brain metastasis.

3. HIV infection, active Hepatitis B or C infection, or active infections requiring oral
or intravenous antibiotics or that can cause a severe disease and pose a severe danger
to lab personnel working on patients' blood or tissue. If positive test results are
not indicative of an active infection, patients can be included.

4. The patient has received chemotherapy, surgery, radiotherapy (for therapeutic
purposes), tyrosine kinase inhibitor (TKI) (e.g. erlotinib, gefitinib),
investigational drugs, chronic use of systemic corticosteroids or statin therapy
within 2 weeks prior to leukapheresis.

5. Previous extensive radiotherapy to the lung or liver during the last 4 months prior to
lymphodepletion regimen.

6. The patient has cardiac conditions defined per protocol

7. Patients with prior stem cell transplantation or solid organ transplantation.

8. The patient has concurrent severe and/or uncontrolled medical disease that could
compromise participation in the study

9. Active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction,
abdominal carcinomatosis or other known risk factors for bowel perforation.

10. History of other malignancies (except for adequately treated basal or squamous cell
carcinoma or carcinoma in situ) within the last 3 years.

11. The patient is pregnant or is breastfeeding.

12. Serious autoimmune disease: Patients with a history of active serious inflammatory
bowel disease (including Crohn's disease and ulcerative colitis) or autoimmune
disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma],
systemic Lupus Erythematosus or autoimmune vasculitis [e.g. Wegener's Granulomatosis]
are excluded from this study.

13. History of hypersensitivity to cyclophosphamide, fludarabine or IL-2.

14. Immunosuppression, not related to prior treatment for malignancy.

15. History of or current immunodeficiency disease or prior treatment compromising immune
function at the discretion of the treating physician.

16. Patients with Grade 3 or higher immune-related toxicities related to prior checkpoint
inhibitors
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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from
Houston, TX
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