Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy

NCT05640713 | Unknown Phase 1

• 1 other identifier: ThisCART19A （FT400-011）
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a a phase 1, open label study to assess the safety and efficacy of ThisCART19 (Allogeneic CAR-T targeting CD19) in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy in china.

Conditions

Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited

Outcome Measures

Primary Outcomes (3)

• Dose limited toxicity(DLT) observation in patient with B Cell Malignancy in each dose level during dose escalation stage

  DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.

  28 days

• Objective Response Rate within 3 months during dose expansion stage

  For Acute Lymphoblastic Leukemia (ALL), Objective response rate(ORR) is the percentage of patients who achieve Complete Response (CR) or Complete Response With Incomplete Hematologic Recovery (CRi); for lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR).

  3 months

• Minimum Residual Disease (MRD) Negative Remission Rate within 3 months during dose expansion stage

  MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. Percentage of participants with MRD negative remission was reported.

  3 months

Secondary Outcomes (4)

• Duration of response(DOR) during dose escalation stage and expansion stage

  24 months

• Relapse-free Survival (RFS)

  24 months

• Event-free Survival (EFS)

  24 months

• Overall Survival (OS)

  24 months

Study Arms (1)

ThisCART19A cells infusion

EXPERIMENTAL

In this study, allogeneic anti-CD19 CAR T cell (ThisCART19A) infusion is used to treat patients with refractory or relapsed CD19 positive B cell acute lymphoblastic leukemia.

Drug: ThisCART19A; Drug: Fludarabine Pill; Drug: Cyclophosphamide; Drug: VP-16 Protocol

Interventions

ThisCART19A DRUG

ThisCART19A is a new type CAR-T therapy for patients with r/r B Cell Malignancy .

ThisCART19A cells infusion

Fludarabine Pill DRUG

Fludarabine is used for lymphodepletion.

ThisCART19A cells infusion

Cyclophosphamide DRUG

Cyclophosphamide is used for lymphodepletion.

ThisCART19A cells infusion

VP-16 Protocol DRUG

VP-16 is used for lymphodepletion.

ThisCART19A cells infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with relapsed or refractory acute lymphocytic leukemia, or lymphoma；
• No gender limitation, Age 14 years to 75 years (both upper and lower limits included)；
• Failing to autologous CAR-T therapy；
• Should be confirmed Cluster of differentiation(CD)19 positive；
• The expected survival time is ≥12 weeks;
• ECOG score 0-1;
• Measurable or detectble disease at time of enrollment.
• Adequate bone marrow, renal, hepatic, pulmonary and cardiac function；

You may not qualify if:

• Allergic to preconditioning measures；
• Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited；
• Uncontrollable bacterial, fungal and viral infection during screening；
• Patients had pulmonary embolism (PE) and/or deep vein thrombosis (DVT) within 3 months prior to enrollment;
• Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment；
• The presence of central nervous system involvement；
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or Syphilis infection. HBV-DNA \< 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment；
• Had big lesion(single lesion diameter ≥10 cm)；
• Receive allogeneic hematopoietic stem cell transplantation less than 100 days；
• Vaccinated with influenza vaccine within 2 weeks prior to cleansing (SARS-COV19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included)；
• Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Fundamenta Therapeutics, Ltd.: collaborator

Study Sites (1)

Henan cancer hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Interventions

fludarabine; Cyclophosphamide; CBV protocol

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Keshu zhou, Dr.

CONTACT

+86-13674902391; drzhouks77@163.com

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 GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: December 1, 2022
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 7, 2022

Record last verified: 2022-11

Locations

CN (1)