Trial Title:
A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed/Refractory Hematologic Malignancies
NCT ID:
NCT06492304
Condition:
T Cell Lymphoma
B Cell Lymphoma
Acute Myeloid Leukemia
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Hematologic Neoplasms
Conditions: Keywords:
CAR T
B Cell Lymphoma
T Cell Lymphoma
Allogeneic
Leukemia
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CTX131
Description:
CTX131 (CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically
modified ex vivo using CRISPR-Cas9 gene editing components
Arm group label:
CTX131
Summary:
This is an open label, multicenter, phase 1/2 dose evaluation and cohort expansion study
evaluating the safety and efficacy of CTX131 in subjects with Relapsed/Refractory
Hematologic Malignancies
Detailed description:
The study may enroll up to 290 subjects in total. CTX131 is a CD70-directed chimeric
antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells prepared for
the treatment of relapsed/refractory hematological malignancies. The cells are from
healthy adult volunteer donors that are genetically modified ex vivo using CRISPR-Cas9
(clustered regularly interspaced short palindromic repeats/ CRISPR-associated protein 9)
gene editing components (single guide RNA and Cas9 nuclease)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. ≥18 years of age
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (ECOG status of
2 will be permitted for subjects with AML)
3. Diagnosed with r/r T Cell Lymphoma (TCL), B Cell Lymphoma (BCL), or Acute Myeloid
Leukemia (AML) T cell lymphoma, including Stage ≥IIB Mycosis fungoides (MF)/ Sézary
syndrome (SS) after at least 2 prior systemic therapies Peripheral T cell lymphoma
(PTCL) after at least 1 prior line of therapy (PTCL-note otherwise specified (NOS),
PTCL-T follicular helper (TFH), Angioimmunoblastic T cell lymphoma (AITL), Adult T
cell leukemia/lymphoma (ATLL) of leukemic, lymphomatous, and chronic unfavorable
subtypes), (ALK)- ALCL after at least 1 prior line of therapy, ALK+ Anaplastic large
cell lymphoma (ALCL) after at least 2 prior lines of therapy
B cell lymphoma, including Diffuse large B cell lymphoma (DLBCL)-NOS, transformed
marginal zone lymphoma(MZL), transformed FL, high-grade BCL with MYC and BCL2 and/or
BCL6 rearrangements, Follicular lymphoma (FL) grade 3b, after at least 2 prior lines
of therapy including an anti- CD20 monoclonal antibody and an anthracycline
containing regimen Mantle cell lymphoma (MCL) after up to 5 prior lines of therapy
which must include an anthracycline- or bendamustine-containing regimen, an anti-
CD20 monoclonal antibody, and a BTK inhibitor
Acute myeloid leukemia or AML/MDS per ELN criteria 2022 after at least 1 prior line
of AML therapy. APL, BCR-ABL positive leukemia, and AML secondary to prior therapy
or history of genetic syndrome associated with BM failure are excluded.
4. Adequate renal, liver, cardiac and pulmonary organ function
5. Females of childbearing potential and male subjects must agree to use an acceptable,
highly effective method of contraception (as specified in the protocol) from
enrollment through at least 12 months after last CTX131 infusion
Exclusion Criteria:
1. Prior treatment with anti-CD70 targeting agents
2. Active CNS manifestation of underlying disease
3. History or presence of clinically relevant CNS pathology such as seizure, stroke,
severe brain injury, cerebellar disease, myelopathy, history of posterior reversible
encephalopathy syndrome with prior therapy, or another condition that in opinion of
investigator may increase CAR T-related toxicities
4. Uncontrolled bacterial, viral, or fungal infection
5. Positive for HIV, or active hepatitis B virus or hepatitis C virus infection.
6. Concurrent systemic treatment with an anticancer biologic (e.g., monoclonal
antibody) within 30 days prior to CTX131 infusion or with a non-biological
anticancer drug within 14 days prior to CTX131 infusion. Mogamulizumab treatment is
prohibited 50 days prior to CTX131 infusion.
7. Diagnosis with another invasive malignancy in the last 5 years with the exception of
non- melanoma skin cancer and malignancies deemed by the investigator and medical
monitor to be of low likelihood for recurrence
8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids
and/or other immunosuppressive therapy.
9. Prior solid organ or allogeneic BM transplantation, except for AML cohorts if at
least 3 months since allogeneic HSCT, not receiving immunosuppressive therapy or
donor lymphocyte infusion post SCT in the 2 weeks prior to lymphodepletion, and have
no clinically active GvHD
10. Treatment with CD19-targeting CAR-T within 6 months prior to CTX131 infusion
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site 6
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research 2
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site 3
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site 5
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site 4
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site 1
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Swaminathan Iyer, MD
Phone:
713-792-5242
Email:
SPIyer@mdanderson.org
Start date:
August 13, 2024
Completion date:
November 2030
Lead sponsor:
Agency:
CRISPR Therapeutics
Agency class:
Industry
Source:
CRISPR Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06492304
