Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies

• Sponsor: Fundamenta Therapeutics, Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04384393
• Collaborator: Anhui Provincial Hospital (Other)
• Enrollment: 30
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 41.5
• Patients Per Site: 15
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This is a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.

Condition or Disease	Intervention/Treatment	Phase
B Cell Malignancy	Biological: ThisCART19 cells	Phase 1

Detailed Description

This is a single-center, nonrandomized, open-label study to evaluate the safety and clinical activity of ThisCART19 in patients with refractory or relapsed CD19 positive B cell malignancies, such as acute or chronic lymphocytic leukemia, lymphoma and etc. The dose range is 0.2-60 x 10^6 cells per kg body weight.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study to Evaluate the Safety and Clinical Activity of Allogeneic Chimeric Antigen Receptor T Cells Targeting CD19 in Patients With Refractory or Relapsed B Cell Malignancies.
• Actual Study Start Date: May 9, 2020
• Anticipated Primary Completion Date: Nov 10, 2022
• Anticipated Study Completion Date: Oct 24, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ThisCART19 cells injections In this study, allogeneic anti-CD19 CAR T Cells(ThisCART19 cells) is used to treat patients with refractory or relapsed CD19 positive B cell malignancies.	Biological: ThisCART19 cells; 0.2-60 x 10^6 CAR T cells per kg body weight.

Outcome Measures

Primary Outcome Measures

1. Incidence of Dose Limiting Toxicities [From infusion to Day 28]

   To assess adverse events as dose limiting toxicities as defined by the protocol.

2. Complete Remission [At Day 28 after ThisCART19 infusion]

   Proportion of patients in whom with morphologic complete remission (CR)

3. TRM: Treatment Related Mortality [Up to 2 years]

   The mortality related with ThisCART19 infusion.

Secondary Outcome Measures

1. Objective Response Rate [Up to 1 year]

   For Acute Lymphoblastic Leukemia (ALL), Objective response rate(ORR) is the percentage of patients who achieve CR or chronic lymphocytic leukemia(CRi); for chronic lymphocytic leukemia (CLL) and lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR).

2. Duration of Response [Up to 1 year]

   Duration of Response (DOR) defined as the duration (days) from initial response to disease relapse, progression, or death due to any course.

3. Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability [From inclusion up to 1 year]

   Adverse events assessed according to NCI-CTCAE v5.0 criteria

4. Overall Survival Rate of 2 Years [At year 2]

   The rate of patients whom alive at year 2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient with relapsed or refractory CD19 positive acute or chronic lymphocytic leukemia, or lymphoma.

2. No alternative treatment options deemed by investigator.

3. Measurable or detectble disease at time of enrollment.

4. Eastern cooperative oncology group (ECOG) performance status of ≤2.

5. Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO).

6. Estimated life expectancy > 12 weeks deemed by investigator.

7. Serum creatinine ≤1.6 mg/dl and/or blood urea nitrogen(BUN) ≤ 1.5 mg/dl .

8. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 upper limit of normal (ULN).

9. Informed consent explained to, understood by and signed by patient/guardian.

Exclusion Criteria:

1. Pregnant or lactating women

2. Uncontrolled infection

3. Active hepatitis B virus or hepatitis C virus infection.

4. Patients who need steroids to control disease.

5. Patients who accepted autologous stem-cell transplantation (ASCT) within 100 days.

6. Patients with grade 2-4 graft-versus-host disease (GVHD), or deemed need to manage by investigator.

7. History of Human Immunodeficiency Virus (HIV) infection.

8. Patients with active central nervous system (CNS) involvement by malignancy.

9. Patients combine with other disease cause neutrophil count (ANC) < 750 per microlitre or platelet count (PLT)< 50,000 per microlitre.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of USTC (Anhui Provincial Hospital)	Hefei	Anhui	China
2	Fundamenta Therapeutice Co.,Ltd	Suzhou	Jiangsu	China

Sponsors and Collaborators

• Fundamenta Therapeutics, Ltd.
• Anhui Provincial Hospital

Investigators

• Principal Investigator: Xingbing Wang, The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fundamenta Therapeutics, Ltd.
• ClinicalTrials.gov Identifier: NCT04384393
• Other Study ID Numbers: ThisCART19
• First Posted: May 12, 2020
• Last Update Posted: Jan 11, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jan 11, 2022