Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is an open label, non-randomized, phase 1 study of anti-CD19 CAR-T cells against relapsed CD19 positive NHL, CLL and ALL based in a lymphodepletion regimen (fludarabine and cyclophosphamide) and using a CellReGen-based process for manufacturing CAR-T cells. This study will utilize a staggered enrollment design with a safety observation period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Subjects aged ≥ 18 years.

• Histologically confirmed relapsed or refractory CD-19+ malignancy, including: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), Chronic Lymphocytic Leukemia (CLL)/Richter's syndrome. CD-19+ must be confirmed by immunohistochemistry or flow cytometry analysis.

• Subjects who have relapsed or refractory disease after failing at least 2 or more prior lines of therapy.

• ECOG Performance Status ≤ 2.

• Life expectancy \> 12 weeks.

• Willing to consent to 15 years of follow-up as part of IRB 110692: Long-Term Evaluation of the Biology and Outcomes of Hematopoietic Stem Cell Transplantation

• Adequate organ function as defined as:

‣ Hematologic:

• Absolute neutrophil count (ANC) ≥ 500/mm3

∙ Platelet count ≥ 10,000/mm3

∙ Hemoglobin ≥ 8 g/dL

⁃ Hepatic:

• Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN).

∙ AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN

⁃ Renal:

• Serum Creatinine ≤ 2 x institutional upper limit of normal (ULN) or eGFR \>30 ml/min/1.73m2

• For subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:

‣ Subjects \< 50 years of age:

• Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and

∙ Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution

⁃ Subjects ≥ 50 years of age:

• Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or

∙ Had radiation-induced menopause with last menses \>1 year ago; or

∙ Had chemotherapy-induced menopause with last menses \>1 year ago

• Subjects of childbearing potential and subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.

• Recovery to baseline or ≤ Grade 2 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered stable by the treating investigator.

• Adequate venous access.

• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

• Step 2 Eligibility Confirmation

‣ The following criteria must be confirmed within 7 days prior to lymphodepletion. If all criteria are not met, lymphodepletion should be delayed.

• Confirmation of successful CAR-T manufacturing.

∙ No evidence or suspicion of an infection.

∙ Serum Creatinine ≤ 2 x institutional upper limit of normal (ULN) or eGFR \>30 ml/min/1.73m2

∙ No worsening of clinical status compared to either the initial eligibility criteria that would, in the opinion of the treating physician, significantly increase the risk from lymphodepleting chemotherapy or exclude them from treatment with study CAR-T therapy.

• Step 3 Eligibility Confirmation

‣ The following criteria must be confirmed prior to CAR-T therapy. If all criteria are not met, CAR-T therapy should be delayed.

• No worsening of clinical status compared to either the initial eligibility criteria that would, in the opinion of the treating physician, significantly increase the risks from treatment with CAR-T therapy.

∙ Confirmation that washout periods outlined in section 6.6 and Appendix 10 have been followed.

Locations
United States
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Contact Information
Primary
Catherine Cromar
Catherine.Cromar@hci.utah.edu
801-213-5652
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2027-01-15
Participants
Target number of participants: 6
Treatments
Experimental: Anti-CD19 CAR-T Cell Infusion
Sponsors
Leads: University of Utah

This content was sourced from clinicaltrials.gov

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