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

NCT ID: NCT05640713

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2025-08-01

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.

Detailed Description

This is a phase 1, single-center, nonrandomized, open-label, dose-escalation and dose expansion study to evaluate the safety and efficacy of ThisCART19A in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy and identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ThisCART19A cells infusion

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.

Group Type: EXPERIMENTAL

ThisCART19A

Intervention Type: DRUG

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

Fludarabine Pill

Intervention Type: DRUG

Fludarabine is used for lymphodepletion.

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide is used for lymphodepletion.

VP-16 Protocol

Intervention Type: DRUG

VP-16 is used for lymphodepletion.

Interventions

ThisCART19A

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

Intervention Type: DRUG

Fludarabine Pill

Fludarabine is used for lymphodepletion.

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide is used for lymphodepletion.

Intervention Type: DRUG

VP-16 Protocol

VP-16 is used for lymphodepletion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patient with relapsed or refractory acute lymphocytic leukemia, or lymphoma；

2. No gender limitation, Age 14 years to 75 years (both upper and lower limits included)；

3. Failing to autologous CAR-T therapy；

4. Should be confirmed Cluster of differentiation(CD)19 positive；

5. The expected survival time is ≥12 weeks;

6. ECOG score 0-1;

7. Measurable or detectble disease at time of enrollment.

8. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function；

Exclusion Criteria

1. Allergic to preconditioning measures；

2. 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；

3. Uncontrollable bacterial, fungal and viral infection during screening；

4. Patients had pulmonary embolism (PE) and/or deep vein thrombosis (DVT) within 3 months prior to enrollment;

5. Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment；

6. The presence of central nervous system involvement；

7. 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；

8. Had big lesion(single lesion diameter ≥10 cm)；

9. Receive allogeneic hematopoietic stem cell transplantation less than 100 days；

10. 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)；

11. Patients who are receiving GvHD treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion；

12. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundamenta Therapeutics, Ltd.

INDUSTRY

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan cancer hospital

Zhengzhou, Henan, China

Countries

China

Central Contacts

Keshu zhou, Dr.

Role: CONTACT

drzhouks77@163.com

+86-13674902391

Jun Li, Ph.D

Role: CONTACT

jli@ctigen.com

+86-18662604088

Other Identifiers

ThisCART19A （FT400-011）

Identifier Type: -

Identifier Source: org_study_id