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Trial Title:
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
Condition:
Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited
Conditions: Official terms:
Neoplasms
Cyclophosphamide
Fludarabine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ThisCART19A
Description:
ThisCART19A is a new type CAR-T therapy for patients with r/r B Cell Malignancy .
Arm group label:
ThisCART19A cells infusion
Intervention type:
Drug
Intervention name:
Fludarabine Pill
Description:
Fludarabine is used for lymphodepletion.
Arm group label:
ThisCART19A cells infusion
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Cyclophosphamide is used for lymphodepletion.
Arm group label:
ThisCART19A cells infusion
Intervention type:
Drug
Intervention name:
VP-16 Protocol
Description:
VP-16 is used for lymphodepletion.
Arm group label:
ThisCART19A cells infusion
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan cancer hospital
Address:
City:
Zhengzhou
Country:
China
Start date:
December 1, 2022
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Fundamenta Therapeutics, Ltd.
Agency class:
Industry
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05640713
