A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)

Sponsor

CRISPR Therapeutics AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04502446

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.

Condition or Disease	Intervention/Treatment	Phase
T Cell Lymphoma	Biological: CTX130	Phase 1

Detailed Description

The study may enroll approximately 45 subjects in total.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Relapsed or Refractory T or B Cell Malignancies

Actual Study Start Date :

Jul 31, 2020

Anticipated Primary Completion Date :

Mar 1, 2027

Anticipated Study Completion Date :

May 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CTX130 Administered by IV infusion following lymphodepleting chemotherapy.	Biological: CTX130 CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.

Arm

Intervention/Treatment

Experimental: CTX130

Administered by IV infusion following lymphodepleting chemotherapy.

Biological: CTX130

CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.

Outcome Measures

Primary Outcome Measures

Part A (dose escalation) [From CTX130 infusion up to 28 days post-infusion]
Incidence of adverse events
Part B (cohort expansion) [From CTX130 infusion up to 60 months post-infusion]]
Objective response rate

Secondary Outcome Measures

Progression Free Survival [From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months]
Overall Survival [From date of CTX130 until date of death due to any cause, assessed up to 60 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria (abbreviated):

Age ≥18 years.
Confirmed diagnosis of a T cell malignancy or Diffuse Large B-Cell Lymphoma (DLBCL).
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Adequate renal, liver, cardiac, and pulmonary organ function.
Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX130 infusion.

Exclusion Criteria (abbreviated):

Prior allogeneic stem cell transplant (SCT).
Prior treatment with any anti-CD70 targeting agents.
History of certain central nervous system (CNS), cardiac or pulmonary conditions.
Active HIV, hepatitis B virus or hepatitis C virus infection.
Previous or concurrent malignancy, except treated with curative approach not requiring systemic therapy and in remission for >12 months, or any other localized malignancy with low risk of developing into metastatic disease.
Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
Prior solid organ transplantation.
Pregnant or breastfeeding females.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site 2	Duarte	California	United States	91010
2	Research Site 5	Stanford	California	United States	94305
3	Research Site 10	New Haven	Connecticut	United States	06520
4	Research Site 4	Miami	Florida	United States	33124
5	Research Site 8	Bronx	New York	United States	10467
6	Research Site 9	New York	New York	United States	10065
7	Research Site 1	Houston	Texas	United States	77030
8	Research Site 6	Salt Lake City	Utah	United States	84112
9	Research Site 3	Sydney	New South Wales	Australia	2050
10	Research Site 7	Toronto	Ontario	Canada	M5G 2C1

Sponsors and Collaborators

CRISPR Therapeutics AG

Investigators

Study Director: Anjali Sharma, MD, CRISPR Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CRISPR Therapeutics AG

ClinicalTrials.gov Identifier:

NCT04502446

Other Study ID Numbers:

CRSP-ONC-004

First Posted:

Aug 6, 2020

Last Update Posted:

May 17, 2022

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by CRISPR Therapeutics AG

CAR T

Allogeneic

Lymphoma

Additional relevant MeSH terms:

Lymphoma, T-Cell

Study Results

No Results Posted as of May 17, 2022