Brief Summary
The goal of the TENACITY-01 clinical trial is to learn if CTD402 UCART is safe and effective for relapsed/refractory T-ALL/LBL patients.
Participants with relapsed/refractory T-ALL/LBL over the age of 12 will be eligible to participate.
Participants will receive one infusion of CTD402 on Day 0 and will be evaluated for anti-tumor activity by an independent review committee based on the NCCN criteria for T-ALL and the Lugano 2014 criteria for T-LBL.
Patients will be followed for up to 24 months in this study and will be required to enroll under a separate long term follow up protocol to be followed for up to 15 years.
Participants with relapsed/refractory T-ALL/LBL over the age of 12 will be eligible to participate.
Participants will receive one infusion of CTD402 on Day 0 and will be evaluated for anti-tumor activity by an independent review committee based on the NCCN criteria for T-ALL and the Lugano 2014 criteria for T-LBL.
Patients will be followed for up to 24 months in this study and will be required to enroll under a separate long term follow up protocol to be followed for up to 15 years.
Brief Title
A Study of CTD402 in T-ALL/LBL Patients
Detailed Description
TENACITY-01 is a single-arm, open-label, multi-center, Phase 1b/2 study to assess the safety and efficacy of CTD402 in adolescent (≥ 12 to 17 years) and adult participants with relapsed/refractory (r/r) T-ALL/LBL. Approximately 18 participants will be enrolled in the Phase 1b portion of the study to evaluate the safety and establish the RP2D of CTD402, with approximately 18 participants receiving CTD402 at RP2D. Approximately 36 participants will be enrolled in the Phase 2 portion of the study to further confirm the efficacy and safety of CTD402.
Both the phase 1b and phase 2 portions will consist of the following sequential phases: screening (up to 2 weeks), lymphodepletion period (within 7 days prior to treatment), CTD402 treatment (a single dose), primary follow-up period (up to 2 years). Once a participant receives the first dose of lymphodepleting chemotherapy regimen, the participant will be considered enrolled into the study.
Long term follow-up will be conducted under a separate protocol until 15 years following CTD402 infusion for survival, toxicity, RCR monitoring, and secondary malignancy.
Both the phase 1b and phase 2 portions will consist of the following sequential phases: screening (up to 2 weeks), lymphodepletion period (within 7 days prior to treatment), CTD402 treatment (a single dose), primary follow-up period (up to 2 years). Once a participant receives the first dose of lymphodepleting chemotherapy regimen, the participant will be considered enrolled into the study.
Long term follow-up will be conducted under a separate protocol until 15 years following CTD402 infusion for survival, toxicity, RCR monitoring, and secondary malignancy.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
917-573-8538
Central Contact Email
clinicaltrials@bioheng.com
Completion Date
Completion Date Type
Estimated
Conditions
Acute Lymphocytic Leukemia Refractory
Lymphoma, Lymphoblastic
Eligibility Criteria
Key Inclusion Criteria:
1. Male or female, ≥ 12 years of age.
2. Participants with body weight ≥ 40 kilogram.
3. Relapsed or refractory T-ALL/LBL is defined as one of the following:
1. Relapsed or refractory disease after two or more lines of systemic therapy;
2. The first relapse occurs within 12 months after first remission;
3. Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period.
4. The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.
5. Have eligible HLA-matched related donor (MRD) or unrelated donor (URD), eligible haploidentical donor (HID) or syngeneic donors.
6. Adequate organ function
7. Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants \< 16) at screening.
Key Exclusion Criteria:
1. Participants with concomitant genetic syndromes associated with bone marrow failure states or any other known bone marrow failure syndrome.
2. Active central nervous system (CNS) involvement
3. Participants with following cardiac conditions will be excluded:
1. History of heart failure New York Heart Association (NYHA) class III or IV;
2. History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment.
4. Primary immune deficiency.
5. Presence of uncontrolled infections.
6. Known history of infection with the human immunodeficiency virus (HIV); hepatitis C virus and syphilis.
7. Active or latent hepatitis B virus infection
8. Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.
1. Male or female, ≥ 12 years of age.
2. Participants with body weight ≥ 40 kilogram.
3. Relapsed or refractory T-ALL/LBL is defined as one of the following:
1. Relapsed or refractory disease after two or more lines of systemic therapy;
2. The first relapse occurs within 12 months after first remission;
3. Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period.
4. The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.
5. Have eligible HLA-matched related donor (MRD) or unrelated donor (URD), eligible haploidentical donor (HID) or syngeneic donors.
6. Adequate organ function
7. Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants \< 16) at screening.
Key Exclusion Criteria:
1. Participants with concomitant genetic syndromes associated with bone marrow failure states or any other known bone marrow failure syndrome.
2. Active central nervous system (CNS) involvement
3. Participants with following cardiac conditions will be excluded:
1. History of heart failure New York Heart Association (NYHA) class III or IV;
2. History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment.
4. Primary immune deficiency.
5. Presence of uncontrolled infections.
6. Known history of infection with the human immunodeficiency virus (HIV); hepatitis C virus and syphilis.
7. Active or latent hepatitis B virus infection
8. Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.
Inclusion Criteria
Inclusion Criteria:
1. Male or female, ≥ 12 years of age.
2. Participants with body weight ≥ 40 kilogram.
3. Relapsed or refractory T-ALL/LBL is defined as one of the following:
1. Relapsed or refractory disease after two or more lines of systemic therapy;
2. The first relapse occurs within 12 months after first remission;
3. Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period.
4. The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.
5. Have eligible HLA-matched related donor (MRD) or unrelated donor (URD), eligible haploidentical donor (HID) or syngeneic donors.
6. Adequate organ function
7. Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants \< 16) at screening.
1. Male or female, ≥ 12 years of age.
2. Participants with body weight ≥ 40 kilogram.
3. Relapsed or refractory T-ALL/LBL is defined as one of the following:
1. Relapsed or refractory disease after two or more lines of systemic therapy;
2. The first relapse occurs within 12 months after first remission;
3. Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period.
4. The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.
5. Have eligible HLA-matched related donor (MRD) or unrelated donor (URD), eligible haploidentical donor (HID) or syngeneic donors.
6. Adequate organ function
7. Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants \< 16) at screening.
Gender
All
Gender Based
false
Keywords
CAR-T Therapy
relapsed/refractory
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
12 Years
NCT Id
NCT07070219
Org Class
Industry
Org Full Name
BIOHENG THERAPEUTICS US LLC
Org Study Id
BHCT-CTD402-201
Overall Status
Recruiting
Phases
Phase 1
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Single-Arm, Open-Label, Multi-Center, Phase 1b/ 2 Study to Evaluate the Safety, Efficacy, and Cellular Pharmacokinetic Profile of CTD402 in Participants With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and Lymphoblastic Lymphoma (T-LBL) (TENACITY-01)
Primary Outcomes
Outcome Description
Incidence of dose limiting toxicities including incidence of adverse events and graft vs host disease
Outcome Measure
Safety Profile
Outcome Time Frame
24 months
Outcome Description
Percentage of participants who achieve overall complete remission (OCR) assess by an independent review committee
Outcome Measure
Response Evaluation
Outcome Time Frame
24 months
Secondary Outcomes
Outcome Description
CTD402 cellular pharmacokinetic (PK)
Outcome Time Frame
24 months
Outcome Measure
Characterize the cPK profile of CTD402
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Roberto Alejandro Sica
Investigator Email
asica@montefiore.org
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Blood & Bone Marrow Cancers --- PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA
Blood & Bone Marrow Cancers --- LEUKEMIA, LYMPHOID
Cancer --- LEUKEMIA
Blood & Bone Marrow Cancers --- LEUKEMIA
Cancer --- NEOPLASMS
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- LYMPHOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- LYMPHATIC DISEASES
Blood & Bone Marrow Cancers --- IMMUNOPROLIFERATIVE DISORDERS
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA
RECURRENCE
LEUKEMIA, LYMPHOID
LEUKEMIA
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
LYMPHOPROLIFERATIVE DISORDERS
LYMPHATIC DISEASES
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES
DISEASE ATTRIBUTES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS