Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With Refractory or Relapsed B Cell Lymphoma

NCT05776407 | Unknown Phase 1

• 1 other identifier: FT400-006-2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1/2, open-label study to assess the efficacy, safety and pharmacokinetics of ThisCART19A (Allogeneic Anti CD19 CAR-T) in patients with refractory or relapsed CD19 positive B cell Lymphoma.

Conditions

Refractory or Relapsed B Cell Lymphoma

Keywords

Allogeneic CAR T，B cell Lymphoma

Outcome Measures

Primary Outcomes (5)

• Dose limited toxicity(DLT) observation in patient with r/r B cell Lymphoma

  DLT was defined as CAR T cells-related events with onset within first 28 days following infusion.

  28 days

• The incidence of all grade TEAEs and ≥3 grade TEAEs

  Incidence of treatment-emergent adverse events (TEAEs) and ≥3 grade TEAEs

  Up to 2 years after ThisCART19A infusion

• Objective Response Rate

  the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment.

  Up to 2 years after ThisCART19A infusion

• Duration of response (DOR)

  DOR is defined as the date of their first CR or PR (which is subsequently confirmed) to PD assessed by investigators and based on the Lugano 2014 assessment criterion for r/r B cell Lymphoma, or death regardless of cause.

  Up to 2 years after ThisCART19A infusion

• Progress-free survival (PFS)

  PFS is defined as the time from the ThisCART19A infusion date to the date of disease progression assessed by investigators and based on the Lugano 2014 assessment criterion, or death any cause.

  Up to 2 years after ThisCART19A infusion

Secondary Outcomes (2)

• TTR (Time to response)

  Up to 2 years after ThisCART19A infusion

• OS (Overall survival)

  Up to 2 years after lymphodepletion

Study Arms (1)

ThisCART19A cells infusion

EXPERIMENTAL

In this study, allogeneic anti-CD19 CAR T cells (ThisCART19A) infusion is used to treat patients with r/r B cell Lymphoma.

Drug: ThisCART19A; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Etoposide

Interventions

ThisCART19A DRUG

Single dose of Allogeneic Anti-CD19 CAR T cells (ThisCART19A) will be infused after the lymphodepletion conditioning of Fludarabine, Cyclophosphamide and Etoposide.

Also known as: Allogeneic Anti-CD19 CAR T cells

ThisCART19A cells infusion

Fludarabine DRUG

Fludarabine is used for lymphodepletion.

ThisCART19A cells infusion

Cyclophosphamide DRUG

Cyclophosphamide is used for lymphodepletion.

ThisCART19A cells infusion

Etoposide DRUG

Etoposide is used for lymphodepletion.

Also known as: VP-16

ThisCART19A cells infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years ≤ age ≤ 65 years.
• Voluntarily sign a documented IRB-approved ICF prior to any screening procedure.
• Patients with histologically confirmed B-cell NHL defined by the World Health Organization (WHO) 2016, including but not limited to diffuse large B-cell lymphoma (DLBCL), follicular lymphoma transferring to DLBCL, mantle cell lymphoma (MCL), follicular lymphoma 3B (FL-3B), original Mediastinal (thymus) large B-cell lymphoma, high-grade B-cell lymphoma and AIDS-associated B-cell lymphoma.
• Prior therapy must have included: Anti-CD20 monoclonal antibody and Anthracycline containing chemotherapy regimen.
• Had available evaluation lesion.
• ECOG(Eastern Cooperative Oncology Group) ≤ 2 or Karnofsky ≥ 60%.
• Serum creatinine≤1.5×ULN or creatinine clearance\>30 mL/min/1.73 m2.
• Alanine aminotransferase(ALT)≤5×ULN(Upper limit of normal) and total bilirubin(TBIL)\<2.0 mg/dL(for patients with Gilbert heald diseases, live involvement and taking atazanavir or indinavir, TBIL\<3.0 mg/dL can be enrolled.)
• Left ventricular ejection fraction(LVEF)≥40%
• Absolute neutrophile counts≥1000/mm3
• Thrombocyte≥30000/mm3
• Total bilirubin(TBIL) ≤ 2.0 mg/dL
• Confirmed Cluster of differentiation(CD)19 positive by biopsy for the patients who received CD19 target therapy before.
• Pregnancy tests for women of childbearing age shall be negative; Both men and women agreed to use effective contraception during treatment and during the subsequent 1 year.
• AIDS Related B Cell Lymphoma :HIV virus loading \< 200 copy/ml and CD4+T cell counts \>200 cells/mm3 within 4 weeks before screening.

You may not qualify if:

• Known for allergic to the preconditioning measures.
• Uncontrollable bacterial, fungal, viral infection before enrollment.
• Patients with pulmonary embolism within 3 months prior enrollment.
• Intolerable serious cardiovascular and cerebrovascular diseases and hereditary diseases.
• Imaging confirmed the presence of central nervous system involvement(including primary and secondary) and rapid progressing diseases.
• Receive allogeneic hematopoietic stem cell transplantation less than 100 days.
• Systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. iIntermittent use of topical, inhaled or intranasal steroids recently or currently. Or systemic disease requiring long-term use of immunosuppression drugs.
• Excluded the patients received Influenza vaccinations within 2 weeks prior to lymphodepletion (Received Severe Acute Respiratory Syndrome-Corona virus disease(SARS-COV)19 vaccines could be included. Received inactivated, live/non-live adjuvant vaccines could be enrolled).
• Excluded women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after infusion. Male subjects planning pregnancy within 1 year after infusion should be excluded.

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead
• Fundamenta Therapeutics, Ltd.: collaborator

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

fludarabine; Cyclophosphamide; Etoposide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

Yao Liu, MD

CONTACT

13228684685; liuyao77@cqu.edu.cn

Jun Li, Ph.D

CONTACT

+86 18662604088; jli@ctigen.com

Study Design

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

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 20, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)