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)
BIOHENG THERAPEUTICS US LLC
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.
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 co…
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
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-mat…
Interventions
- DrugCTD402 CAR T Cell Injection
CAR T cells
Locations (8)
- Stanford UniversityPalo Alto, California
- Colorado Blood Cancer InstituteDenver, Colorado
- University of ChicagoChicago, Illinois
- Mayo Clinic - RochesterRochester, Minnesota
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Montefiore Einstein Comprehensive Cancer CenterThe Bronx, New York