Allogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies

NCT05391490 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: UCL/1269002021-002878-88
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

KCAT19 is a single-centre, non-randomised, open-label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in adults (age 16-65 years) with high risk, relapsed/refractory (r/r) B cell malignancies.

Conditions

Blood Cancer

Keywords

CAR T cells; leukemia; lymphoma

Outcome Measures

Primary Outcomes (2)

• KCAT 19 T cell generation feasibility

  Feasibility of generation of T cell receptor-negative KCAT19 T cells as evaluated by the number of therapeutic products generated.

  Up to 28 days after last patient is recruited

• KCAT19 T cell Toxicity

  Toxicity following KCAT19 T cell administration as evaluated by the incidence of grade 3-5 toxicity causally related to the ATIMP

  Up to 28 days after last patient treated

Secondary Outcomes (7)

• Response rate

  6 months after last patient treated with ATIMP

• KCAT19 T cell persistence

  After last treated patient completes the 2 year follow up visit

• KCAT19 T cell persistence

  After last treated patient completes the 2 year follow up visit

• Hypogammaglobulinaemia and B cell aplasia

  2 years after last patient treated

• Time to Disease Progression

  2 years after last patient treated

Study Arms (1)

Single Arm Trial

EXPERIMENTAL

Treatment with Lymphodepletion followed by a dose of KCAT19 T cells.

Genetic: KCAT19 T cells

Interventions

KCAT19 T cells GENETIC

Allogeneic, cord unit derived KCAT19 T cells

Single Arm Trial

Eligibility Criteria

• Age: 16 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 16-65 years
• Relapsed or refractory B cell malignancy following at least 2 prior lines of therapy:
• B-ALL: relapsed or refractory B-ALL following standard therapy, requiring salvage, in whom alternative therapies are deemed inappropriate by their treating physician Or LBCL: relapsed/refractory DLBCL (incl. transformed FL but not Richter's transformation) or PMBCL following ≥2 prior lines of therapy which must include Rituximab, anthracycline and autologous CD19 CAR, (unless CD19 CAR cannot be manufactured) Or MCL: relapsed/ refractory disease following ≥2 lines of therapy which must include Rituximab, Bruton's tyrosine kinase inhibitor and autologous CD19CAR therapy (unless CD19 CAR cannot be manufactured) Or Indolent B-NHL (either Follicular Lymphoma, Marginal Zone Lymphoma or other low-grade lymphoma) which is relapsed / refractory following ≥2 prior lines of therapy which must include anti-CD20 therapy and chemotherapy with anthracycline or bendamustine.
• CD19+ disease
• Agreement to have a pregnancy test, use adequate contraception (if applicable)
• Written informed consent

You may not qualify if:

• CD19 negative disease
• Active CNS involvement of disease
• Diagnosis of chronic lymphocytic leukaemia/ small lymphocytic lymphoma or Burkitt lymphoma
• Active hepatitis B, C or HIV infection
• Oxygen saturation ≤ 90% on air
• Bilirubin \>2 x upper limit of normal
• GFR \<30ml/min
• Women who are pregnant or breast feeding
• Stem Cell Transplant patients only: active significant acute GvHD (overall Grade ≥ II, Modified Glucksberg criteria) or moderate/severe chronic GvHD (NIH consensus criteria) requiring immunosuppressive therapy and/or systemic steroids
• Karnofsky score \<60%
• Known allergy to albumin or DMSO
• Patients receiving corticosteroids at a dose of \>5 mg prednisolone per day (or equivalent) that cannot be discontinued
• Life expectancy \<3 months
• Cardiac dysrhythmias (excluding well-controlled AF or other supraventricular tachycardia) or significant cardiac disease and left ventricular ejection fraction \<40%
• Patients who can reasonably access autologous CD19 CAR treatment as part of standard of care or a clinical trial\*

Sponsors & Collaborators

• University College, London: lead

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

David Gear

CONTACT

0207 670 5748; ctc.kcat19@ucl.ac.uk

Alex Day

CONTACT

ctc.kcat19@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre, non-randomised, open-label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP)

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 26, 2022
• Study Start: October 1, 2022
• Primary Completion: November 1, 2024
• Study Completion (Estimated): November 1, 2034
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share